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Alendronate: Drug information

Alendronate: Drug information
2025© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Alendronate: Patient drug information" and "Alendronate: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Binosto;
  • Fosamax
Brand Names: Canada
  • ACH-Alendronate;
  • AG-Alendronate;
  • AG-Alendronate Sodium;
  • Alendronate-70;
  • APO-Alendronate;
  • Auro-Alendronate;
  • DOM-Alendronate [DSC];
  • DOM-Alendronate-FC [DSC];
  • Fosamax;
  • GEN-Alendronate;
  • JAMP-Alendronate;
  • JAMP-Alendronate Sodium;
  • M-Alendronate;
  • MINT-Alendronate;
  • NRA-Alendronate;
  • PMS-Alendronate-FC;
  • RIVA-Alendronate FC;
  • SANDOZ Alendronate;
  • TEVA-Alendronate
Pharmacologic Category
  • Bisphosphonate Derivative
Dosing: Adult
Osteoporosis, fracture risk reduction

Osteoporosis, fracture risk reduction

Note: Correct hypocalcemia and vitamin D deficiency (eg, to a 25-hydroxyvitamin D level ≥20 ng/mL [≥50 nmol/L]) prior to initiating therapy and ensure adequate calcium and vitamin D intake during therapy (Ref).

Males and postmenopausal females:

Patients with high fracture risk, including those with a history of fragility fracture, or males ≥50 years of age and postmenopausal females with a T-score of −2.5 or lower or a T-score between −1 and −2.5 at high fracture risk according to a risk assessment (Ref):

Treatment: Oral: 70 mg once weekly or 10 mg once daily.

Patients without high fracture risk, including those with a T-score between −1 and −2.5 and who are not at high fracture risk according to a risk assessment, but who desire pharmacologic therapy for prevention of bone loss or fracture (Ref):

Prevention: Oral: 35 mg once weekly or 5 mg once daily.

Duration of therapy: The optimal duration of therapy has not been established. Consider discontinuing after 5 years if bone mineral density (BMD) is stable, there have been no previous fragility fractures, and short-term fracture risk is low. If fracture risk remains high (eg, fragility fracture before or during therapy), consider extending therapy for up to 10 years or switching to alternative therapy. If discontinued, the decision to resume therapy is based on multiple factors, including decline in BMD and risk factors for fracture (Ref).

Glucocorticoid-induced:

Note: For use in males ≥50 years of age and postmenopausal females with osteoporosis and receiving any glucocorticoids, or with a T-score between −1 and −2.5 and moderate or higher fracture risk according to a risk assessment who are expected to receive systemic glucocorticoids for ≥3 months at a prednisone dose of ≥7.5 mg/day (or its equivalent), or who are taking high dose glucocorticoids (eg, prednisone ≥30 mg/day for >1 month) irrespective of other factors (Ref). In younger males and premenopausal females, patient selection must be individualized (Ref). Avoid use in females who are pregnant, who plan on becoming pregnant, or who are not using effective birth control (Ref).

Prevention (off-label use) or treatment: Oral: 70 mg once weekly (Ref) or 10 mg once daily (Ref).

Duration of therapy: The optimal duration of treatment has not been established; duration should be individualized based on continuation of glucocorticoid therapy and fracture risk (Ref).

Paget disease, treatment

Paget disease, treatment (alternative agent): Note: For symptomatic patients with active disease and select patients with asymptomatic disease (eg, abnormal biochemical marker, prior to planned surgery at an active pagetic site) (Ref).

Initial: Oral: 40 mg once daily for 6 months (Ref).

Re-treatment: A second course (ie, 40 mg orally once daily for 6 months) may be considered following a 6-month posttreatment evaluation period in patients whose serum alkaline phosphatase normalized during initial treatment but then subsequently rose above normal after discontinuation or if serum alkaline phosphatase failed to normalize during the initial course (Ref).

Prostate cancer, bone loss associated with androgen deprivation therapy

Prostate cancer, bone loss associated with androgen deprivation therapy (alternative agent) (off-label use):

Note: For use in males without bone metastases treated long term with androgen deprivation therapy who are at elevated risk of osteoporotic fractures (eg, T-score of –2.5 or lower, prior fragility fracture, or T-score between –1 and –2.5 at high fracture risk according to a risk assessment tool) (Ref). Due to uncertain efficacy relative to preferred agents, some experts recommend against the use of alendronate for this indication unless preferred agents are unavailable or inappropriate (Ref).

Oral: 70 mg once weekly (Ref).

Missed doses (once weekly): If a once-weekly dose is missed, administer the next morning after remembered; then return to the original scheduled day of the week on the once-weekly schedule; however, do not administer 2 doses on the same day.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function:

CrCl ≥35 mL/minute: No dosage adjustment necessary.

CrCl <35 mL/minute: Use not recommended (manufacturer’s labeling). However, based on limited data, use of an unadjusted dose may be considered in patients with CrCl of >25 to <35 mL/minute and without underlying CKD-mineral and bone disorder when the benefits outweigh the risks (Ref).

Hemodialysis, intermittent (thrice weekly): Not dialyzed (Ref): Use not recommended (Ref).

Peritoneal dialysis: Use not recommended (Ref).

Dosing: Liver Impairment: Adult

The liver dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Matt Harris, PharmD, MHS, BCPS, FAST, FCCP; Jeong Park, PharmD, MS, BCTXP, FCCP, FAST; Arun Jesudian, MD; Sasan Sakiani, MD.

Note: Alendronate is not metabolized and is excreted in the urine (Ref). Use with caution, avoid, or delay initiation in patients with recent treatment for esophageal varices (eg, banding or sclerotherapy) or consider an alternative agent that can be administered parenterally (Ref).

Liver impairment prior to treatment initiation:

Child-Turcotte-Pugh class A to C: No dosage adjustment necessary (Ref).

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Alendronate: Pediatric drug information")

Dosage guidance:

Clinical considerations: Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.

Osteogenesis imperfecta

Osteogenesis imperfecta: Note: Intravenous bisphosphonates may be preferred over oral options due to improved outcomes (Ref).

Daily dosing: Limited data available, dosing regimens and efficacy results variable (Ref):

Children ≥2 years and Adolescents:

≤30 kg: Oral: 5 mg once daily.

30 to <40 kg: 5 or 10 mg once daily.

≥40 kg: Oral: 10 mg once daily.

Osteopenia/Osteoporosis, patients with acute lymphoblastic leukemia

Osteopenia /Osteoporosis, patients with acute lymphoblastic leukemia:

Weekly dosing: Limited data available: (Ref):

Children ≥3 years and Adolescents:

15 to <25 kg: Oral: 20 mg once weekly.

25 to <35 kg: Oral: 30 mg once weekly.

35 to <45 kg: Oral: 40 mg once weekly.

45 to <55 kg: Oral: 50 mg once weekly.

55 to <65 kg: Oral: 60 mg once weekly.

≥65 kg: Oral: 70 mg once weekly.

Osteopenia/Osteoporosis, patients with chronic diseases

Osteopenia/Osteoporosis , patients with chronic diseases (eg, connective tissue disorders, cystic fibrosis, rheumatologic disorders): Limited data available, optimal regimen not defined:

Daily dosing (Ref):

Children ≥4 years and Adolescents:

<20 kg: Oral: 5 mg once daily.

20 to <30 kg: Oral: 5 or 10 mg once daily.

≥30 kg: Oral: 10 mg once daily.

Weekly dosing (Ref):

Children ≥11 years and Adolescents:

≤30 kg: Oral: 35 mg once weekly.

>30 kg: Oral: 70 mg once weekly.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no pediatric-specific recommendations provided in the manufacturer's labeling; based on experience in adult patients, use is not recommended in patients with a CrCl of <35 mL/minute.

Dosing: Liver Impairment: Pediatric

There are no pediatric-specific recommendations provided in the manufacturer's labeling; based on experience in adult patients, no adjustment required.

Adverse Reactions (Significant): Considerations
Atypical femur fractures

Atypical femur fractures (AFF) have been reported with bisphosphonate use, including alendronate. The fractures include subtrochanteric femur (bone just below the hip joint) and diaphyseal femur (long segment of the thigh bone). The benefits of therapy (when used for osteoporosis) generally outweigh the absolute risk of AFF within the first 5 years of treatment, especially in patients with high fracture risk (Ref). The risk decreases after bisphosphonate discontinuation (Ref). AFF is estimated to occur in ~0.2 % of bisphosphonate users after ≥5 years of therapy (Ref).

Mechanism: Time-related. Long-term suppression of bone turnover may be primarily responsible; however, microdamage accumulation and alterations of collagen cross-linking have also been postulated (Ref).

Onset: Delayed; most fractures have occurred in patients receiving bisphosphonates (including alendronate) for at least 3 to 5 years (Ref). Patients may experience prodromal pain weeks or months before the fracture occurs (Ref). Patients may also exhibit precursory signs of AFF (eg, thickening of the lateral cortex) on radiographic evaluation before developing a fracture (Ref).

Risk factors:

• Long-term treatment (>3 to 5 years) (Ref)

• Asian people (in North America) (Ref)

• Femoral bowing (Ref)

• Glucocorticoid use (>1 year) (Ref)

GI mucosal irritation

Esophagitis, dysphagia, esophageal ulcer, erosive esophagitis, esophageal stenosis, and esophageal perforation have been reported with bisphosphonate use, including alendronate (Ref). Oropharyngeal ulcer has also been noted (Ref). Experiencing a GI event increases the likelihood of decreased compliance at 1 year (Ref) or discontinuation (Ref).

Mechanism: GI mucosal irritation is secondary to the local effect of alendronate on the gastric mucosa (as opposed to a systemic effect) (Ref).

Onset: Varied; dependent upon the type of mucosal injury, but case reports have noted onset within 2 days to 12 months after initiation (Ref).

Risk factors:

• Incorrect administration technique (ie, <180 mL water, lying down after administration, chewing or sucking a bisphosphonate tablet) (Ref)

• Older adults (Ref)

• Concurrent nonsteroidal anti-inflammatory drug or antithrombotic use (Ref)

• Prior GI issues (Ref)

• Oral administration of bisphosphonates (as compared to IV administration) (Ref)

Hypocalcemia

While transient decreased serum calcium is expected with the use of alendronate (and all bisphosphonates) secondary to their mechanism of action, cases of symptomatic hypocalcemia have been reported (Ref). Hypocalcemia may occur in patients with or without comorbid hypoparathyroidism and is reversible with discontinuation of alendronate, regardless of cause (Ref).

Mechanism: By decreasing osteoclast activity, calcium is not released into the bloodstream, causing a transient decrease in blood calcium. In patients with normally functioning parathyroid glands, calcium homeostasis is regained shortly after starting the bisphosphonate (Ref).

Onset: Varied; case reports have noted onset of symptomatic hypocalcemia within 10 days to 12 weeks of initiation (Ref).

Risk factors:

• Baseline hypocalcemia (Ref)

• Impaired kidney function (Ref)

• Impaired parathyroid function (Ref)

• IV bisphosphonate (Ref)

• Vitamin D deficiency (Ref)

• Thyroidectomy (Ref)

Musculoskeletal pain

Severe and occasionally debilitating musculoskeletal pain involving the bones, joints, and/or muscles has been reported during treatment with a bisphosphonate, including alendronate (Ref). Symptoms may resolve upon discontinuation (Ref). Severe musculoskeletal pain may occur independent of an associated acute phase reaction (eg, fever, chills, bone pain, myalgias, arthralgias) that is more often associated with IV administration of a bisphosphonate or an initial exposure to once-weekly or once-monthly oral bisphosphonate therapy (Ref).

Mechanism: Not clearly established; may or may not be related to an acute phase reaction mediated by interleukin-6, tumor necrosis factor-alpha, and other pro-inflammatory cytokines (Ref).

Onset: Varied; may occur within days, months, or years following initiation (Ref). In one descriptive study (n=107), the onset ranged from 1 day to 52 months (median: 14 days) following initiation of alendronate (Ref).

Risk factors:

• Prior history of severe musculoskeletal pain associated with bisphosphonate use; some patients experience recurrence when rechallenged with the same drug or another bisphosphonate (Ref).

Osteonecrosis of the jaw

Osteonecrosis of the jaw (ONJ) was first described in dental literature (Ref) with the use of IV bisphosphonates. However, there is conflicting evidence of whether this risk is seen with oral bisphosphonates, such as alendronate, or is simply an increased risk in those who are treated with agents for osteoporosis (Ref). ONJ is most commonly reversible and not life-threatening; however, the possibility of ONJ increases the risk of nonadherence (Ref).

Mechanism: Dose- and time-related; exact mechanism unknown, but several hypothesized mechanisms exist, such as oversuppression of bone turnover (Ref), mucosal toxicity (Ref), cytokine-mediated inflammation (Ref), and infection (Ref).

Onset: Varied; may occur following years of bisphosphonate therapy or occurrence can be spontaneous or after insult, such as tooth extraction and/or dental implant procedures (Ref).

Risk factors:

• Alcohol use disorder (Ref)

• Anemia (Ref)

• Cancer and anticancer therapy (Ref)

• Corticosteroid therapy (Ref)

• Dental extraction and/or dental implant procedures (Ref)

• Diabetes (Ref)

• Extended duration (>3 years) of bisphosphonate (Ref)

• High-dose, IV bisphosphonate (Ref)

• Immunological disorders (Ref)

• Oral surgery or trauma (Ref)

• Poor oral hygiene (Ref)

• Poorly fitting dental appliance (Ref)

• Radiotherapy to head and neck (Ref)

• Tobacco smoking (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Incidences of adverse reactions (mostly GI) increase significantly in patients treated for Paget disease at 40 mg/day.

>10%: Endocrine & metabolic: Decreased serum calcium (18%; transient, mild) (table 1)

Alendronate: Adverse Reaction: Decreased Serum Calcium

Drug (Alendronate)

Placebo

Population

Indication

18%

12%

Females

Osteoporosis

1% to 10%:

Endocrine & metabolic: Decreased serum phosphate (10%; transient, mild)

Gastrointestinal: Abdominal distension (≤1%), abdominal pain (2% to 7%), acid regurgitation (1% to 5%), constipation (≤3%), diarrhea (≤3%), dyspepsia (1% to 3%), dysphagia (0.1% to 1%) (table 2), esophageal ulcer (0.1% to 2%) (table 3), flatulence (≤4%), gastric ulcer (≤1%; may be severe with complications), gastritis (≤1%), gastroesophageal reflux disease (3%), melena (1%), nausea (1% to 3%)

Alendronate: Adverse Reaction: Dysphagia

Drug (Alendronate)

Placebo

Population

Indication

Number of Patients (Alendronate)

Number of Patients (Placebo)

1%

0%

Females

Osteoporosis

196

397

0.1%

0.1%

Females

Osteoporosis

3,236

3,223

Alendronate: Adverse Reaction: Esophageal Ulcer

Drug (Alendronate)

Placebo

Population

Indication

Number of Patients (Alendronate)

Number of Patients (Placebo)

2%

0%

Females

Osteoporosis

196

397

0.1%

0.1%

Females

Osteoporosis

3,236

3,223

Nervous system: Headache (3%)

Neuromuscular & skeletal: Muscle cramps (≤1%), musculoskeletal pain (0.4% to 6%) (table 4)

Alendronate: Adverse Reaction: Musculoskeletal Pain

Drug (Alendronate)

Placebo

Population

Dose

Indication

Number of Patients (Alendronate)

Number of Patients (Placebo)

Comments

4%

3%

Females

N/A

Osteoporosis

196

397

Includes bone pain, joint pain, muscle pain

3%

N/A

Females

70 mg once weekly

Osteoporosis

519

N/A

Includes bone pain, joint pain, muscle pain

3%

N/A

Females

10 mg once daily

Osteoporosis

370

N/A

Includes bone pain, joint pain, muscle pain

2%

N/A

Females

5 mg once daily

Osteoporosis

361

N/A

Includes bone pain, joint pain, muscle pain

2%

N/A

Females

35 mg once weekly

Osteoporosis

362

N/A

Includes bone pain, joint pain, muscle pain

0.8%

0.9%

Females

5 mg once daily

Osteoporosis

642

648

Includes bone pain, joint pain, muscle pain

0.4%

0.3%

Females

N/A

Osteoporosis

3,236

3,223

Includes bone pain, joint pain, muscle pain

~6%

~1%

N/A

40 mg once daily

Paget disease

175

N/A

N/A

<1%: Gastrointestinal: Dysgeusia

Postmarketing:

Cardiovascular: Peripheral edema

Dermatologic: Alopecia, erythema of skin, skin rash (occasionally with photosensitivity), Stevens-Johnson syndrome, toxic epidermal necrolysis

Endocrine & metabolic: Hypocalcemia (symptomatic) (Ref)

Gastrointestinal: Duodenal ulcer (may be severe with complications), erosive esophagitis (Ref), esophageal perforation (Ref), esophageal stenosis (Ref), esophagitis (Ref)

Hypersensitivity: Hypersensitivity reaction (includes angioedema, urticaria) (Ref)

Nervous system: Asthenia, dizziness, malaise, vertigo

Neuromuscular & skeletal: Femur fracture (low-energy fractures, including atypical subtrochanteric and diaphyseal) (Ref), joint swelling, osteonecrosis (cholesteatoma of the external auditory canal), osteonecrosis of the jaw (Ref)

Ophthalmic: Episcleritis, scleritis (Ref), uveitis (Ref)

Respiratory: Exacerbation of asthma, oropharyngeal ulcer (Ref)

Miscellaneous: Fever

Contraindications

Hypersensitivity to alendronate or any component of the formulation; hypocalcemia; abnormalities of the esophagus (eg, stricture, achalasia) which delay esophageal emptying; inability to stand or sit upright for at least 30 minutes; increased risk of aspiration (effervescent tablets; oral solution)

Canadian labeling: Additional contraindications (not in the US labeling): Renal insufficiency with CrCl <35 mL/minute

Warnings/Precautions

Disease-related concerns:

• Bariatric surgery: Altered absorption and ulceration risk: Avoid oral bisphosphates after bariatric surgery; inadequate oral absorption and potential anastomotic ulceration may occur. If therapy is indicated, IV administered bisphosphonates are recommended.

• Renal impairment: Use with caution in patients with renal impairment.

Dosage form specific issues:

• Effervescent tablet: Each effervescent tablet contains 603 mg of sodium (NaCl 1,532 mg). Use with caution in patients following a sodium-restricted diet. Note: Prior to October 2020, the sodium content was listed as 650 mg/tablet (NaCl 1,650 mg/tablet) in the manufacturer’s labeling.

Warnings: Additional Pediatric Considerations

Possible decreased bone remodeling affecting growth or fracture healing may occur with bisphosphonate therapy; a case report in an adolescent treated with high-dose pamidronate described abnormal long-bone modeling (Rauch 2004); a large, placebo-controlled osteogenesis imperfecta trial (n=109, age range: 4 to 19 years) reported that alendronate did not interfere with fracture healing (Ward 2011).

Product Availability

Alendronate 40 mg tablets have been discontinued in the US for more than 1 year.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Oral:

Generic: 70 mg/75 mL (75 mL)

Tablet, Oral:

Fosamax: 70 mg

Generic: 5 mg, 10 mg, 35 mg, 70 mg

Tablet Effervescent, Oral:

Binosto: 70 mg

Generic Equivalent Available: US

May be product dependent

Pricing: US

Solution (Alendronate Sodium Oral)

70 mg/75 mL (per mL): $1.15

Tablet, effervescent (Binosto Oral)

70 mg (per each): $90.00

Tablets (Alendronate Sodium Oral)

5 mg (per each): $2.93

10 mg (per each): $2.93

35 mg (per each): $0.69 - $52.83

70 mg (per each): $0.80 - $59.08

Tablets (Fosamax Oral)

70 mg (per each): $46.30

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Fosamax: 70 mg

Generic: 5 mg, 10 mg, 40 mg, 70 mg

Administration: Adult

Oral: Administer first thing in the morning and ≥30 minutes before the first food, beverage (except plain water), or other medication(s) of the day. Do not take with mineral water or with other beverages. Patients should be instructed to stay upright (not to lie down) for ≥30 minutes and until after first food of the day (to reduce esophageal irritation).

Oral solution: Administer oral solution, followed with ≥2 oz of plain water.

Tablet (Fosamax): Must be taken with 6 to 8 oz of plain water. The tablet should be swallowed whole; do not chew or suck.

Tablet, effervescent (Binosto): Do not swallow, chew, or allow undissolved tablet to dissolve in mouth. Dissolve one tablet in 4 oz of room temperature plain water only; once effervescence stops, wait ≥5 minutes and stir the solution for ~10 seconds and then drink.

Administration: Pediatric

Oral: Administer first thing in the morning and ≥30 minutes before the first food, beverage (except plain water), or other medication of the day. Do not take with mineral water or with other beverages. Remain upright (do not lie down) for at least 30 minutes and until after first food of the day (to reduce esophageal irritation).

Oral solution: Follow administration of oral solution with at least 2 oz of plain water.

Tablet (Fosamax): Must be taken with 6 to 8 oz of plain water. The tablet should be swallowed whole; do not chew or suck on the tablet.

Tablet, effervescent (Binosto): Dissolve one tablet in 4 oz (120 mL) of room temperature plain water only; once effervescence stops, wait ≥5 minutes and stir the solution for ~10 seconds and then drink.

Missed doses: Once weekly dosing: If a once-weekly dose is missed, it should be given the next morning after remembered; then return to the original scheduled day of the week on the once-weekly schedule; however, do not give 2 doses on the same day.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Binosto: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/BinostoMedGuide.pdf

Fosamax: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s068,021575s024lbl.pdf#page=24

Use: Labeled Indications

Osteoporosis:

Binosto: Treatment of osteoporosis in postmenopausal females and to increase bone mass in males with osteoporosis.

Fosamax: Treatment and prevention of osteoporosis in postmenopausal females; treatment to increase bone mass in males with osteoporosis; treatment of glucocorticoid-induced osteoporosis in patients with low bone mineral density who are receiving a prednisone dosage of ≥7.5 mg/day (or equivalent).

Paget disease: Fosamax: Treatment of Paget disease of the bone in patients (males and females) who are symptomatic, at risk for future complications, or with alkaline phosphatase ≥2 times the upper limit of normal.

Use: Off-Label: Adult

Osteoporosis, glucocorticoid-induced, prevention; Prostate cancer, bone loss associated with androgen deprivation therapy

Medication Safety Issues
Sound-alike/look-alike issues:

Alendronate may be confused with risedronate

Fosamax may be confused with Flomax, Fosamax Plus D, fosinopril, Zithromax

International issues:

Fosamax [US, Canada, and multiple international markets] may be confused with Fisamox brand name for amoxicillin [Australia]

Older Adult: High-Risk Medication:

Bisphosphonates are identified in the Screening Tool of Older Person's Prescriptions (STOPP) criteria as a potentially inappropriate medication in older adults (≥65 years of age). Some disease states of concern include kidney disease and gastrointestinal disease (O’Mahony 2023).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Aminoglycosides: May increase hypocalcemic effects of Bisphosphonate Derivatives. Aminoglycosides may increase nephrotoxic effects of Bisphosphonate Derivatives. Risk C: Monitor

Angiogenesis Inhibitors (Systemic): May increase adverse/toxic effects of Bisphosphonate Derivatives. Specifically, the risk for osteonecrosis of the jaw may be increased. Risk C: Monitor

Aspirin: May increase adverse/toxic effects of Alendronate. Specifically, the incidence of upper gastrointestinal adverse events may be increased Risk C: Monitor

Deferasirox: Bisphosphonate Derivatives may increase adverse/toxic effects of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor

Inhibitors of the Proton Pump (PPIs and PCABs): May decrease therapeutic effects of Bisphosphonate Derivatives. Risk C: Monitor

Nonsteroidal Anti-Inflammatory Agents: May increase adverse/toxic effects of Bisphosphonate Derivatives. Both an increased risk of gastrointestinal ulceration and an increased risk of nephrotoxicity are of concern. Risk C: Monitor

Palopegteriparatide: Bisphosphonate Derivatives may decrease therapeutic effects of Palopegteriparatide. Bisphosphonate Derivatives may increase therapeutic effects of Palopegteriparatide. Risk C: Monitor

Parathyroid Hormone: Alendronate may decrease therapeutic effects of Parathyroid Hormone. More specifically, Alendronate may interfere with normalization of blood calcium concentrations. Risk X: Avoid

Polyvalent Cation Containing Products: May decrease serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of oral medications containing polyvalent cations within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. Risk D: Consider Therapy Modification

Food Interactions

All food and beverages interfere with absorption. Coadministration with dairy products may decrease alendronate absorption. Beverages (especially orange juice, coffee, and mineral water) and food may reduce the absorption of alendronate as much as 60%. Management: Alendronate must be taken first thing in the morning and ≥30 minutes before the first food, beverage (except plain water), or other medication of the day.

Reproductive Considerations

Underlying causes of osteoporosis should be evaluated and treated prior to considering bisphosphonate therapy in patients prior to menopause; effective contraception is recommended when bisphosphonate therapy is used in patients who could become pregnant (Cohen 2017; Pepe 2020). Bisphosphonates are incorporated into the bone matrix and gradually released over time; exposure prior to pregnancy may theoretically increase the risk of fetal harm (Stathopoulos 2011). Bisphosphonate use should be avoided in patients planning to become pregnant within 12 months (Pepe 2020), although recommendations vary as when to stop bisphosphonates prior to a planned pregnancy (Chakrabarti 2023).

Bisphosphonates can be considered for the prevention and treatment of glucocorticoid-induced osteoporosis in premenopausal patients with moderate or higher fracture risk who do not plan to become pregnant during the treatment period and who are using effective birth control (or are not sexually active) (ACR [Humphrey 2023]). Bisphosphonates should be used for the shortest duration possible (Chakarabarti 2023). An agent with a shorter skeletal half-life (eg, risedronate) may be preferred in patients who could become pregnant (ACR [Humphrey 2023]; Chakarabarti 2023).

Pregnancy Considerations

It is not known if bisphosphonates cross the placenta, but based on their lower molecular weight, fetal exposure is expected (Djokanovic 2008; Stathopoulos 2011).

Outcome data related to the use of alendronate in pregnancy are available (Gerin 2016; Green 2014; Levy 2009; Ornoy 2006; Sokal 2019; Stathopoulos 2011).

Bisphosphonates are incorporated into the bone matrix and gradually released over time. The amount available in the systemic circulation varies by drug, dose, and duration of therapy. Theoretically, there may be a risk of fetal harm when pregnancy follows the completion of therapy (hypocalcemia, low birth weight, and decreased gestation have been observed in some case reports); however, available data have not shown that exposure to bisphosphonates during pregnancy significantly increases the risk of adverse fetal events (Djokanovic 2008; Green 2014; Levy 2009; Machairiotis 2019; Sokal 2019; Stathopoulos 2011). Exposed infants should be monitored for hypocalcemia after birth (Djokanovic 2008; Stathopoulos 2011).

Changes in bone metabolism that occur during pregnancy and postpartum may be associated with the development of pregnancy- and lactation-associated osteoporosis (PLAO). Data related to the pharmacologic treatment and duration of treatment of PLAO are limited and specific recommendations are not available. Bisphosphonates may be one option when treatment is initiated postpartum (Anagnostis 2024; Hardcastle 2022; Pepe 2020; Qian 2021).

Breastfeeding Considerations

It is not known if alendronate is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Changes in bone metabolism that occur during pregnancy and postpartum may be associated with the development of pregnancy- and lactation-associated osteoporosis (PLAO). Data related to the pharmacologic treatment and duration of treatment of PLAO are limited and specific recommendations are not available. Bisphosphonates may be one option when treatment is initiated postpartum; breastfeeding is not recommended (Anagnostis 2024; Hardcastle 2022; Pepe 2020; Qian 2021).

Dietary Considerations

Ensure adequate calcium and vitamin D intake; if dietary intake is inadequate, dietary supplementation is recommended. Patients should consume:

Calcium: 1,000 mg/day (males: 50 to 70 years of age) or 1,200 mg/day (females ≥51 years of age and males ≥71 years of age) (IOM 2011; NOF [Cosman 2014]).

Vitamin D: 800 to 1,000 units/day (age ≥50 years) (NOF [Cosman 2014]). Recommended dietary allowance (RDA): 600 units daily (age ≤70 years) or 800 units/day (age ≥71 years) (IOM 2011).

Monitoring Parameters

Osteoporosis: Serial bone mineral density (BMD) should be evaluated at baseline and every 1 to 3 years on treatment (usually at ~2 years following initiation of therapy, then more or less frequently depending on patient-specific factors and stability of BMD) (AACE/ACE [Camacho 2020]; ES [Eastell 2019]; NOF [Cosman 2014]); evaluate BMD every 2 to 4 years during a drug holiday (ES [Eastell 2019]); in patients with combined alendronate and glucocorticoid treatment, evaluate BMD at initiation of glucocorticoid therapy and after 6 to 12 months, then every 2 to 3 years if patient continues to have significant osteoporosis risk factors (ACR [Humphrey 2023]); annual measurements of height and weight, assessment of chronic back pain; serum calcium (prior to and during therapy) and 25(OH)D; may consider monitoring biochemical markers of bone turnover (eg, fasting serum CTX or urinary NTX) at baseline, 3 months, and 6 months, to assess treatment response, adherence to therapy, and/or possible malabsorption (ES [Eastell 2019]).

Paget disease: Serum total alkaline phosphatase at 6 to 12 weeks for initial response to treatment (when bone turnover will have shown a substantial decline) and potentially at 6 months (maximal suppression of high bone turnover); following treatment completion, monitor at ~6- to 12-month intervals (ES [Singer 2014]); monitoring more specific biochemical markers of bone turnover (eg, serum P1NP, NTX, serum beta-CTx) is generally only warranted in patients with Paget disease who have abnormal liver or biliary tract function or when early assessment of response to treatment is needed (eg, spinal compression, very active disease) (ES [Singer 2014]); pain (posttreatment pain may not strictly correlate with increased biochemical markers [Ralston 2019]); serum calcium (prior to and during therapy) and 25(OH)D.

Femur fracture in patients presenting with thigh or groin pain (during or after treatment; if fracture identified, also evaluate contralateral limb).

Mechanism of Action

A bisphosphonate which inhibits bone resorption via actions on osteoclasts or on osteoclast precursors; decreases the rate of bone resorption, leading to an indirect increase in bone mineral density. In Paget disease, characterized by disordered resorption and formation of bone, inhibition of resorption leads to an indirect decrease in bone formation; but the newly-formed bone has a more normal architecture.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: 28 L (exclusive of bone)

Protein binding: ~78%

Metabolism: None

Bioavailability: Fasting:

Children ≥4 years and Adolescents: Mean range: 0.41% to 0.56% (Nakhla 2011; Ward 2005)

Adults: 0.6%; reduced up to 60% with coffee or orange juice

Half-life elimination: Exceeds 10 years

Excretion: Urine; feces (as unabsorbed drug)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Elimination may be reduced.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Fosamax | Fozanate | Lendomax;
  • (AR) Argentina: Actimax | Alenato | Alendronato Austral | Alendronato denver farma | Alendronato Lepetit | Alendronato northia | Apo alendronate | Arendal | Berlex | Brek | Elandur | Findeclin | Fosamax | Lendronal | Marvil | Oseotenk | Osteofene | Osteonate | Pamoseo | Phostarac | Regenesis | Reyoin | Rixofem | Silidral | Tilios;
  • (AT) Austria: Alendris | Alendrohexal | Alendromax | Alendron | Alendronat-Nycomed | Alendronsaeure 1A Pharma | Alendronsaeure Actavis | Alendronsaeure Arcana | Alendronsaeure bluefish | Alendronsaeure Pfizer | Alendronsaeure ratiopharm | Alendronsaeure sandoz | Alendronstad | Fosamax;
  • (AU) Australia: Alendro | Alendrobell | Alendronate an | Alendronate pfizer | Alendronate sandoz | Alendronate-GA | Apo alendronate | Chemmart alendronate | Cm Alendronate | Densate | Fonat | Fosamax | Genrx Alendronate | Ossmax | Terry white chemists alendronate | Tw Alendronate;
  • (BD) Bangladesh: Alendon | Ostel;
  • (BE) Belgium: Alendromed | Alendronate Accord | Alendronate EG | Alendronate Merck | Alendronate Mylan | Alendronate pfizer | Alendronate Ratiopharm | Alendronate sandoz | Alendronate teva | Alendroninezuur Apotex | Fosamax;
  • (BF) Burkina Faso: Alendro | Bifosa | Ralenost;
  • (BG) Bulgaria: Alendronat Actavis | Alendronic acid | Forosa | Fosamax | Fosamax ow | Fosanate | Lindron | Tevanate;
  • (BR) Brazil: Alendil | Alendosseo | Alendrin | Alendronato de sodio | Alendronato sodico | Alendrus | Bonagran | Bonalen | Boneprev | Cleveron | Endronax | Endrostan | Endrox | Fosamax | Ledar | Minusorb | Ossomax | Ostelox | Ostenan | Osteofar | Osteoform | Osteoral | Ostrat | Ostrazil | Recalfe | Terost;
  • (CH) Switzerland: Alendron Mepha | Alendronat Actavis | Alendronat Adico | Alendronat Helvepharm | Alendronat sandoz | Alendronat Spirig | Alendronat Streuli | Alendronat Teva | Alendronat zentiva | Binosto | Fosamax;
  • (CI) Côte d'Ivoire: Alendro | Bifosa | Osteonate;
  • (CL) Chile: Aldrox | Arendal | Fosamax | Fosval | Holadren | Leodrin | Oseotal | Oseum | Osteosan;
  • (CN) China: An lun | Fosamax | Gu bang | Tian ke;
  • (CO) Colombia: Alendrobal | Alendronato | Alendronato mk | Arendal | Armol | Bifemelan | Eucalen | Fixopan | Fosamax | Indrol | Labinfost | Lokar | Neobon | Osdronat | Osficar | Osfidronat | Ostertrin | Ostex | Osticalcin | Secnitron | Tibolene;
  • (CZ) Czech Republic: Alendronat Actavis | Alendronat Pliva | Alendronat sandoz | Alendronic acid aurobindo | Apo alendronat | Fosamax | Fosteofos | Gendron | Lindron | Siranin;
  • (DE) Germany: Alendro Ksk | Alendro-Q | Alendromed | Alendron | Alendron einmal woechentlich | Alendron Hexal | Alendron Sandoz | Alendronat Acis | Alendronate pfizer | Alendronsaeure 1A Pharma | Alendronsaeure AbZ | Alendronsaeure Actavis | Alendronsaeure AL | Alendronsaeure AWD | Alendronsaeure Axcount | Alendronsaeure Basics | Alendronsaeure bioeq pharma | Alendronsaeure bluefish | Alendronsaeure CT | Alendronsaeure dura | Alendronsaeure Heumann | Alendronsaeure ratiopharm | Alendronsaeure stada | Alendronsaeure tecnimede | Alendronsaeure Volkspharma | Binosto | Fosamax | Tevanate;
  • (DK) Denmark: Alendronat Ratiopharm;
  • (DO) Dominican Republic: Alendronato | Alendronato Exels | Alendronato genfar | Arendal | Armol | Defixal | Dronat | Fixopan | Fosamax | Foseron | Fosfalen | Fosfoplus | Nor Ospor | Oseomax | Ossifix | Osteofel | Osteomax | Osteonato | Osteoplus | Porosin;
  • (EC) Ecuador: Acido alendronico nifa | Aldrox | Alendral | Alendronato | Alendronato mk | Alendronato nifa | Alendronato sodico | Alendrostioxx | Armol | Endronal | Eskeleton | Eucalen | Fixopan | Fosamax | Fosmin | Fosval | Lendronat | Ostat | Osteomix | Oxtalen | Porosin;
  • (EE) Estonia: Alendronic acid stada | Alenotop | Fosamax | Lendrate | Sedron;
  • (EG) Egypt: Alendene | Alendex | Alendomax | Bonalene | Bonapex | Borgalendro | Fosamax | Nofract | Osteomax | Osteomepha | Osteonate;
  • (ES) Spain: Acido alendronico | Acido alendronico Apotex | Acido alendronico ciclum | Acido alendronico mabo | Acido Alendronico pensa | Acido Alendronico Semanal | Acido alendronico semanal Aurobindo | Acido alendronico semanal Cuve | Acido alendronico semanal Davur | Acido alendronico semanal Normon | Acido alendronico semanal Pharmagenus | Acido alendronico semanal Qualigen | Acido alendronico semanal Ranbaxy | Acido alendronico semanal Rimafar | Acido alendronico semanal Tecnimede | Acido alendronico semanal Vir | Acido alendronico Stada | Adelan semanal | Alenvir Semanal | Bifoal semanal | Binosto | Calbion semanal | Fosamax | Lefosan semanal | Semandrol semanal | Soludronate semanal;
  • (ET) Ethiopia: Lendomax | Sodium alendronate;
  • (FI) Finland: Alendronat Actavis | Alendronat Arrow | Alendronat Bluefish | Alendronat mylan | Alendronat Orifarm | Alendronat Pfizer | Alendronat Ranbaxy | Alendronat Ratiopharm | Alendronat sandoz | Binosto | Bonasol | Fosamax;
  • (FR) France: Acide alendronique | Acide Alendronique Almus | Acide Alendronique Alter | Acide Alendronique Arrow | Acide Alendronique Biogaran | Acide Alendronique EG | Acide alendronique evolugen | Acide Alendronique Merck | Acide alendronique phr lab | Acide Alendronique Qualimed | Acide alendronique Ranbaxy | Acide Alendronique Ratiopharm | Acide Alendronique Sandoz | Acide Alendronique Teva | Acide alendronique winthrop | Acide Alendronique Zydus | Bonasol | Fosamax | Steovess;
  • (GB) United Kingdom: Alendronic | Alendronic acid | Alendronic Almus | Binosto | Fosamax;
  • (GR) Greece: Aledrolet | Alendral | Alendronate/mylan | Arthroplus | Aurodren | Binosto | Bone-aid | Debenal | Delfoza | Deparex | Dronalent | En Por | Enimon | Farmemax | Forosa | Fosalen | Fosamax | Fosandron | Fosazom | Ledronin | Linadax | Lozostun | Meldoz | Moralen | Mosmass | Osaston | Ostalert | Ostaven | Porocalm | Ridon | Zakodronate | Zemaros | Zulgar;
  • (HK) Hong Kong: Acido alendronico | Alendon | Alendronate | Alendronate sandoz | Alovell | Apo alendronate | Bifosa | Euromax | Fosamax | Mosmass | Osteofos | Reventa | Samix;
  • (HR) Croatia: Aledox | Alendor | Forosa | Fosamax | Fosamax T | Valora;
  • (HU) Hungary: Epolar | Fosamax | Massidron | Sedron | Trabecan teva;
  • (ID) Indonesia: Alenoxal | Alovell | Fosamax | Nichospor | Oslene | Osteofar | Voroste;
  • (IE) Ireland: Alendronic acid | Alendronic acid bluefish once weekly | Binosto | Bonasol | Fosamax | Fostepor | Fostolin | Osteomel | Romax | Tevanate;
  • (IL) Israel: Alendronate teva | Fosalan | Maxibone;
  • (IN) India: Aldren | Alenost | Bifosa | Denfos | Dronal | Ostalen | Osteofos | Ostonat | Ralenost | Restofos | Zophost;
  • (IR) Iran, Islamic Republic of: Osteofose;
  • (IT) Italy: Acido alendronico aurobindo | Acido alendronico tecnigen | Acido alendronico zentiva | Adronat | Alendronato | Alendronato Aahcl | Alendronato Actavis | Alendronato almus | Alendronato Bentley | Alendronato Doc | Alendronato EG | Alendronato Pensa | Alendronato Sandoz | Alendros | Aston | Binosto | Bonasol | Dralenos | Dronal | Fosamax | Genalen | Glamor | Loss | Porodron | Realen;
  • (JO) Jordan: Alendronate sandoz | Alfa Porosis | Bonmax | Calidron | Dargol | Drolate | Fosamax | Foznate;
  • (JP) Japan: Alendronate | Alendronate amel | Alendronate Mylan | Alendronate Towa | Alendronic acid towa | Bonalon | Fosamac;
  • (KE) Kenya: Bongard | Landronate | Maxlen | Menofos | Osteofos | Reventa;
  • (KR) Korea, Republic of: Aidbon | Airend | Aland | Alangdelon | Albone | Aldren | Aledlon | Aledron | Alen d | Alend | Alenda | Alendrex | Alendro | Alendronate | Alendros | Alene | Alenfos | Alenmax | Alenstar | Alent | Alentop | Aleron | Alfomax | Allenmax | Allentop | Alobon | Alonate | Alont | Alront | Arangdron | Arenbon | Arond | Ausomax | Binosto | Bisbon | Bolend | Bonadron | Bonaid | Bonalen | Bonamax | Bonmax | Bonomax | Bonpill | Calmax | Daewoong alendronate | Foalen | Folend | Forend | Forenmax | Fosaalen | Fosaalon | Fosalen | Fosalend | Fosalong | Fosalonin | Fosamax | Fosanet | Fosaqueen | Fosaron | Ginodron | Gynodron | Kingdron | Lite alendron | Malend | Marend | Marvil | Masibone | Masibone s | Momax | Newsendro | Os | Parend | Polenmax | Posaronin | Tevanate | Tibone | Tibone weekly;
  • (KW) Kuwait: Alendro | Alendronate sandoz | Fosamax | Fozanate | Lendomax | Osteo;
  • (LB) Lebanon: Alendomax | Bonmax | Drolate | Fosamax | Osteomed | Osteve;
  • (LT) Lithuania: Acido alendronico semanal Kern Pharma | Alendon | Alendronic acid accord | Alendronic acid actiopharma | Alenotop | Fosamax | Lindron | Ralenost | Sedron | Tevanate;
  • (LU) Luxembourg: Alendron | Alendronate EG | Alendronate sandoz | Alendronsaeure Ratio | Beenos | Fosamax | Ostacid;
  • (LV) Latvia: Fosamax | Ostemax | Ralenost;
  • (MA) Morocco: Acide Alendronique Gt | Acide Alendronique Normon | Adronat | Anor | Fosamax | Inros;
  • (MX) Mexico: Alendronato | Alendronato Ultra | Alsix | Apodrolen | Bifosmac | Blindafe | Cistros | Denofel | Dronadil | Drovitan | Fosalacin | Fosamax | Kalosten | Landrolen | Lenadrin | Oxivag | Sinfract | Synostep | Zeroclast;
  • (MY) Malaysia: Alendronate | Alendronate sandoz | Alendronic acid | Apo alendronate | Apodrolen | Binosto | Fosamax | Ralenost;
  • (NL) Netherlands: Alendroninezr | Alendroninezuur A | Alendroninezuur Accord | Alendroninezuur actavis | Alendroninezuur cf | Alendroninezuur KR | Alendroninezuur mylan | Alendroninezuur PCH | Alendroninezuur ratiopharm | Alendroninezuur sandoz | Bonasol | Dronal | Fosamax;
  • (NO) Norway: Adronat | Alendronat | Alendronat Arrow | Alendronat Bluefish | Alendronat Teva | Alendronat Unimedic | Alendronic acid accord | Alendronic acid teva | Alendroninezuur PCH | Binosto | Fosamax;
  • (NZ) New Zealand: Fosamax;
  • (PE) Peru: Acido alendronico | Alendra 7 | Alendron | Alendronato | Alendronato sodico | Alendroporosis | Alenost | Alostal | Arendal | Bonaliv | Durost | Endronal | Eucalen | Fijacalcin | Fixopan | Fosamax | Fosavit | Fosmin | Fosval | Holadren | Lafedam | Leandronato | Marvil | Osteosan | Poris | Zondral;
  • (PH) Philippines: Aldren | Alendra | Alendroxl | Alovell | Binosto | Bondros | Forosa | Fosamax | Osteocor | Osteomax | Reventa | Tevanate;
  • (PK) Pakistan: Alendrate | Alendroflex | Alendrogen | Alendrowin | Alidium | Andonat | Bonafide | Bonate | Bonfit | Bongard | Bonpart | Bostrong | Botic | Denfos | Drate | Dyronate | Firmofos | Fosamax | Fosnate | Lendra | No prosis | Orthonate | Ossel | Ostamed | Osteopor | Reventa;
  • (PL) Poland: Alenato | Alendran | Alendrolek | Alendronat aurobindo | Alendronat Bluefish | Alendronate Arrow | Alendronic acid genoptim | Alenotop | Fosamax | Lindron | Osalen | Ostemax comfort | Ostenil | Ostodronic | Ostolek | Rekostin;
  • (PR) Puerto Rico: Binosto | Fosamax;
  • (PT) Portugal: Acido alendronico | Acido alendronico almus | Acido alendronico arrowblue | Acido alendronico aurobindo | Acido Alendronico Azevedos | Acido alendronico bifosal | Acido Alendronico Farmoz | Acido alendronico frosst | Acido alendronico generis | Acido Alendronico GP | Acido alendronico j. neves | Acido alendronico jaba | Acido alendronico Mepha | Acido alendronico ratiopharm | Acido alendronico sandoz | Adronat | Alegonat | Aleostito | Binosto | Bonasol | Fosamax;
  • (PY) Paraguay: Alend | Alendronato dallas | Alendronato genfar | Arendal | Atralon | Discal | Fosval | Holadren | Osteol;
  • (QA) Qatar: Alendro | Alendronate Sandoz | Binosto | Fosamax Once Weekly | Osteo-Acino | Osteve;
  • (RO) Romania: Acid alendronic accord | Acid alendronic aurobindo | Alendronat sandoz | Fosamax | Ranos | Tevanat;
  • (RU) Russian Federation: Alendrokern | Alendronate | Binosto | Forosa | Fosamax | Lindron | Ostalon | Osterepar | Strongos | Tevanate;
  • (SA) Saudi Arabia: Alendocan | Alendro | Alendronate sandoz | Apo alendronate | Bonamax | Drolate | Fosamax | Fozanate | Lendomax | Osteo | Osteodens | Osteomax | Osteve | Pms-alendronate;
  • (SE) Sweden: Alenat | Alendronat Accord | Alendronat aristo veckotablett | Alendronat Arrow | Alendronat aurobindo veckotablett | Alendronat Bluefish | Alendronat ebb veckotablett | Alendronat mds veckotablett | Alendronat mylan | Alendronat Orifarm | Alendronat paranova veckotablett | Alendronat Ranbaxy | Alendronat sandoz | Alendronat Stada | Alendronat Teva | Alendronat Unimedic | Binosto | Fosamax;
  • (SG) Singapore: Alendronate sandoz | Apo alendronate | Binosto | Fosamax | Lendomax;
  • (SI) Slovenia: Alenax | Alendor | Alendronat Arrow | Fosamax | Lindron | Tevanate;
  • (SK) Slovakia: Alendromax | Alendronat | Fosamax | Gendron | Siranin | Tevalen;
  • (SR) Suriname: Alendronate | Alendronic acid | Alendroninezuur Accord | Alendroninezuur actavis | Alendroninezuur mylan | Apo alendronate;
  • (TH) Thailand: Aldren | Alendronate sandoz | Bonmax | Fosamax | Maxlen | Pleofix | Ralenost;
  • (TN) Tunisia: Fosalen | Fosamax;
  • (TR) Turkey: Alemaks | Andante | As Aldeks | Bonacton | Bonemax | Fosamax | Osalen | Osteomax | Vegabon;
  • (TW) Taiwan: Alendronate sandoz | Apo alendronate | Binosto | Covaxin | Fosamax;
  • (UA) Ukraine: Alendon 10 | Alendon 70 | Alendra | Alendronat sandoz | Alendronat stoma | Fosamax | Londromax | Ostemax | Osteo | Osteofos | Ralenost;
  • (UG) Uganda: Aldren | Alendronate | Reventa;
  • (UY) Uruguay: Alendral | Alendronato | Bones | Gerical | Marvil | Osteonato | Osteopor;
  • (VE) Venezuela, Bolivarian Republic of: Acido alendronico | Aldronac | Alendron | Alendronato | Alendronato sodico | Aliot | Defixal | Denfos | Fixopan | Fosamax | Genalmen | Osteodur | Osteomax | Porosal;
  • (VN) Viet Nam: Messi | Sagafosa | Vonland;
  • (ZA) South Africa: Accord Alendronate | Aldren | Alendronate | Alendronate unicorn | Boniran | Densate | Fosamax | Ostena | Osteobon | Osteonate | Ran alendronate | Solibon;
  • (ZM) Zambia: Alendro | Relenost | Zophost
  1. Adachi JD, Saag KG, Delmas PD, et al. Two-year effects of alendronate on bone mineral density and vertebral fracture in patients receiving glucocorticoids: a randomized, double-blind, placebo-controlled extension trial. Arthritis Rheum. 2001;44(1):202-211. doi:10.1002/1529-0131(200101)44:1<202::AID-ANR27>3.0.CO;2-W [PubMed 11212161]
  2. Adler RA, El-Hajj Fuleihan G, Bauer DC, et al. Managing osteoporosis in patients on long-term bisphosphonate treatment: report of a Task Force of the American Society for Bone and Mineral Research [published correction appears in J Bone Miner Res. 2016;31(10):1910]. J Bone Miner Res. 2016;31(1):16-35. doi: 10.1002/jbmr.2708. [PubMed 26350171]
  3. Aibar Arregui MA, de Escalante Yangüela B, Muñoz Villalengua M, Garcés Horna V. Esophageal stenosis caused by alendronate. Rev Esp Enferm Dig. 2011;103(6):338-339. doi: 10.4321/s1130-01082011000600015. [PubMed 21736407]
  4. Akcay T, Turan S, Guran T, Bereket A. Alendronate treatment in children with osteogenesis imperfecta. Indian Pediatr. 2008;45(2):105-109 [PubMed 18310788]
  5. Alendronate sodium oral solution [prescribing information]. Berkeley Heights, NJ: Hikma Pharmaceuticals USA Inc; September 2020.
  6. Alendronate sodium tablet [prescribing information]. East Windsor, NJ: Aurobindo Pharma USA, Inc; July 2023.
  7. Alendronate sodium tablet [prescribing information]. Warren, NJ: Cipla USA, Inc; September 2020.
  8. Alibhai SMH, Zukotynski K, Walker-Dilks C, et al; Cancer Care Ontario Genitourinary Cancer Disease Site Group. Bone health and bone-targeted therapies for prostate cancer: a programme in evidence-based care - Cancer Care Ontario clinical practice guideline. Clin Oncol (R Coll Radiol). 2017;29(6):348-355. doi:10.1016/j.clon.2017.01.007 [PubMed 28169118]
  9. Allen MR, Burr DB. The pathogenesis of bisphosphonate-related osteonecrosis of the jaw: so many hypotheses, so few data. J Oral Maxillofac Surg. 2009;67(5 Suppl):61-70. doi:10.1016/j.joms.2009.01.007 [PubMed 19371816]
  10. Allen CS, Yeung JH, Vandermeer B, Homik J. Bisphosphonates for steroid-induced osteoporosis. Cochrane Database Syst Rev. 2016;10(10):CD001347. doi:10.1002/14651858.CD001347.pub2 [PubMed 27706804]
  11. American Dental Association Council on Scientific Affairs, “Dental Management of Patients Receiving Oral Bisphosphonate Therapy,” JADA, 2006, 137(8):1144-50. Available at http://jada.ada.org/article/S0002-8177(14)64960-6/pdf [PubMed 16873332]
  12. Anagnostis P, Lampropoulou-Adamidou K, Bosdou JK, et al. Comparative effectiveness of therapeutic interventions in pregnancy and lactation-associated osteoporosis: a systematic review and meta-analysis. J Clin Endocrinol Metab. 2024;109(3):879-901. doi:10.1210/clinem/dgad548 [PubMed 37708365]
  13. Apkon S, Coll J. Use of weekly alendronate to treat osteoporosis in boys with muscular dystrophy. Am J Phys Med Rehabil. 2008;87(2):139-143. [PubMed 17912140]
  14. APO-Alendronate (alendronate) [product monograph]. Toronto, Ontario, Canada: Apotex Inc; February 2024.
  15. Author Unknown. Safety update: bone-building drugs: risks explained. Consum Rep Health. 2006. 18(5):3.
  16. Axelsson KF, Nilsson AG, Wedel H, Lundh D, Lorentzon M. Association between alendronate use and hip fracture risk in older patients using oral prednisolone. JAMA. 2017;318(2):146-155. doi:10.1001/jama.2017.8040 [PubMed 28697254]
  17. Bailie GR, Mason NA. Bailie and Mason’s 2020 Dialysis of Drugs. Renal Pharmacy Consultants LLC. 2020.
  18. Bhalla AK. Management of osteoporosis in a pre-menopausal woman. Best Pract Res Clin Rheumatol. 2010;24(3):313-327. doi:10.1016/j.berh.2010.01.006 [PubMed 20534366]
  19. Bianchi ML, Cimaz R, Bardare M, et al. Efficacy and safety of alendronate for the treatment of osteoporosis in diffuse connective tissue diseases in children: a prospective multicenter study. Arthritis Rheum. 2000;43(9):1960-1966. [PubMed 11014345]
  20. Bianchi ML, Colombo C, Assael BM, et al. Treatment of low bone density in young people with cystic fibrosis: a multicentre, prospective, open-label observational study of calcium and calcifediol followed by a randomised placebo-controlled trial of alendronate. Lancet Respir Med. 2013;1(5):377-385. doi:10.1016/S2213-2600(13)70064-X [PubMed 24429202]
  21. Binosto (alendronate) [prescribing information]. Boston, MA: Radius Health Inc; October 2023.
  22. Binosto (alendronate) [prescribing information]. Morristown, NJ: Ascend Therapeutics; December 2021.
  23. Black DM, Abrahamsen B, Bouxsein ML, Einhorn T, Napoli N. Atypical femur fractures: review of epidemiology, relationship to bisphosphonates, prevention, and clinical management. Endocr Rev. 2019;40(2):333-368. doi: 10.1210/er.2018-00001. [PubMed 30169557]
  24. Black DM, Geiger EJ, Eastell R, et al. Atypical femur fracture risk versus fragility fracture prevention with bisphosphonates. N Engl J Med. 2020;383(8):743-753. doi:10.1056/NEJMoa1916525 [PubMed 32813950]
  25. Bock O, Boerst H, Thomasius FE, et al. Common musculoskeletal adverse effects of oral treatment with once weekly alendronate and risedronate in patients with osteoporosis and ways for their prevention. J Musculoskelet Neuronal Interact. 2007;7(2):144-148. [PubMed 17627083]
  26. Bruder JM, Ma JZ, Wing N, Basler J, Katselnik D. Effects of alendronate on bone mineral density in men with prostate cancer treated with androgen deprivation therapy. J Clin Densitom. 2006;9(4):431-437. [PubMed 17097529]
  27. Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists/American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis-2020 update. Endocr Pract. 2020;26(suppl 1):s1-s46. doi:10.4158/GL-2020-0524SUPPL [PubMed 32427503]
  28. Cartsos VM, Zhu S, and Zavras AI, “Bisphosphonate Use and the Risk of Adverse Jaw Outcomes: A Medical Claims Study of 714,217 People,” J Am Dent Assoc, 2008, 139(1):23-30. [PubMed 18167381]
  29. Chakrabarti K, McCune WJ. Glucocorticoid-induced osteoporosis in premenopausal women: management for the rheumatologist. Curr Opin Rheumatol. 2023;35(3):161-169. doi:10.1097/BOR.0000000000000934 [PubMed 36943706]
  30. Charles JF. Treatment of Paget disease of bone. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 17, 2021.
  31. Chesnut CH 3rd, Harris ST. Short-term effect of alendronate on bone mass and bone remodeling in postmenopausal women. Osteoporos Int. 1993;3 suppl 3:S17-19. doi: 10.1007/BF01623003. [PubMed 8298198]
  32. Chiu WY, Chien JY, Yang WS, Juang JM, Lee JJ, Tsai KS. The risk of osteonecrosis of the jaws in Taiwanese osteoporotic patients treated with oral alendronate or raloxifene. J Clin Endocrinol Metab. 2014;99(8):2729-2735. doi: 10.1210/jc.2013-4119. [PubMed 24758181]
  33. Christodoulou C, Pervena A, Klouvas G, et al. Combination of bisphosphonates and antiangiogenic factors induces osteonecrosis of the jaw more frequently than bisphosphonates alone. Oncology. 2009;76(3):209-211. [PubMed 19212145]
  34. Cimaz R, Gattorno M, Sormani MP, et al. Changes in markers of bone turnover and inflammatory variables during alendronate therapy in pediatric patients with rheumatic diseases. J Rheumatol. 2002;29(8):1786-1792. [PubMed 12180745]
  35. Cohen A. Premenopausal osteoporosis. Endocrinol Metab Clin North Am. 2017;46(1):117-133. doi:10.1016/j.ecl.2016.09.007 [PubMed 28131128]
  36. Collier J. Bone disorders in chronic liver disease. Hepatology. 2007;46(4):1271-1278. doi:10.1002/hep.21852 [PubMed 17886334]
  37. Cosman F, de Beur SJ, LeBoff MS, et al; National Osteoporosis Foundation. Clinician's guide to prevention and treatment of osteoporosis. Osteoporos Int. 2014;25(10):2359-2381. doi:10.1007/s00198-014-2794-2 [PubMed 25182228]
  38. de Nijs RN, Jacobs JW, Lems WF, et al; STOP Investigators. Alendronate or alfacalcidol in glucocorticoid-induced osteoporosis. N Engl J Med. 2006;355(7):675-684. doi: 10.1056/NEJMoa053569. [PubMed 16914703]
  39. de Groen PC, Lubbe DF, Hirsch LJ, et al. Esophagitis associated with the use of alendronate. N Engl J Med. 1996;335(14):1016-1021. doi:10.1056/NEJM199610033351403 [PubMed 8793925]
  40. Dioguardi M, Di Cosola M, Copelli C, et al. Oral bisphosphonate-induced osteonecrosis complications in patients undergoing tooth extraction: a systematic review and literature updates. Eur Rev Med Pharmacol Sci. 2023;27(13):6359-6373. doi:10.26355/eurrev_202307_32996 [PubMed 37458653]
  41. Djokanovic N, Klieger-Grossmann C, and Koren G, "Does Treatment With Bisphosphonates Endanger the Human Pregnancy?" J Obstet Gynaecol Can, 2008, 30(12):1146-8. [PubMed 19175968]
  42. Durie BG, Katz M, and Crowley J, "Osteonecrosis of the Jaw and Bisphosphonates," N Engl J Med, 2005, 353(1):99-102. [PubMed 16000365]
  43. Eastell R, Rosen CJ, Black DM, Cheung AM, Murad MH, Shoback D. Pharmacological management of osteoporosis in postmenopausal women: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2019;104(5):1595-1622. doi:10.1210/jc.2019-00221 [PubMed 30907953]
  44. Edwards BJ, Hellstein JW, Jacobsen PL, et al, “Updated Recommendations for Managing the Care of Patients Receiving Oral Bisphosphonate Therapy: An Advisory Statement From the American Dental Association Council on Scientific Affairs,” J Am Dent Assoc, 2008, 139(12):1674-7. [PubMed 19047674]
  45. Eguchi T, Basugi A, Kanai I, Miyata Y, Hamada Y. Multiple oral ulcers caused by incorrect use of oral bisphosphonate in a patient with dementia: a case report. Gerodontology. 2019;36(1):82-84. doi:10.1111/ger.12378 [PubMed 30461047]
  46. Expert opinion. Senior Hepatic Editorial Team: Matt Harris, PharmD, MHS, BCPS, FAST, FCCP; Jeong Park, PharmD, MS, BCTXP, FCCP, FAST; Arun Jesudian, MD; Sasan Sakiani, MD.
  47. Expert opinion. Senior Renal Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
  48. FDA Drug Safety Communication 2018. FDA Drug Safety Communication: Safety update for osteoporosis drugs, bisphosphonates, and atypical fractures. Published October 13, 2010. Accessed November 23, 2020. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-safety-update-osteoporosis-drugs-bisphosphonates-and-atypical.
  49. Filleul O, Crompot E, and Saussez S, "Bisphosphonate-Induced Osteonecrosis of the Jaw: A Review of 2,400 Patient Cases," J Cancer Res Clin Oncol, 2010, 136(8):1117-24. [PubMed 20508948]
  50. Finkelstein JS, Yu EW. Treatment of osteoporosis in men. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 12, 2021.
  51. Fosamax (alendronate) [prescribing information]. Jersey City, NJ: Organon LLC; June 2021.
  52. Fosamax (alendronate) [product monograph]. Kirkland, Quebec, Canada: Organon Canada Inc; August 2023.
  53. Fosamax (alendronate) [product monograph]. Kirkland, Quebec, Canada: Organon Canada Inc; May 2021.
  54. Galluzzo S, Santini D, Vincenzi B, et al. Immunomodulating role of bisphosphonates on human gamma delta T cells: an intriguing and promising aspect of their antitumour activity. Expert Opin Ther Targets. 2007;11(7):941-954. doi: 10.1517/14728222.11.7.941. [PubMed 17614762]
  55. Guañabens N, Monegal A, Cerdá D, et al. Randomized trial comparing monthly ibandronate and weekly alendronate for osteoporosis in patients with primary biliary cirrhosis. Hepatology. 2013;58(6):2070-2078. doi:10.1002/hep.26466 [PubMed 23686738]
  56. Guañabens N, Parés A, Ros I, et al. Alendronate is more effective than etidronate for increasing bone mass in osteopenic patients with primary biliary cirrhosis. Am J Gastroenterol. 2003;98(10):2268-2274. doi:10.1111/j.1572-0241.2003.07639.x [PubMed 14572578]
  57. Gerin M, Jambon G, Fouque-Aubert A, et al. Neonatal transient hypophosphatemic hypercalciuric rickets in dizygous twins: A role for maternal alendronate therapy before pregnancy or antireflux medications? Arch Pediatr. 2016;23(9):957-962. [PubMed 27150561]
  58. Gertz BJ, Holland SD, Kline WF, et al. Studies of the oral bioavailability of alendronate. Clin Pharmacol Ther. 1995;58(3):288-298. doi:10.1016/0009-9236(95)90245-7. [PubMed 7554702]
  59. Green SB, Pappas AL. Effects of maternal bisphosphonate use on fetal and neonatal outcomes. Am J Health Syst Pharm. 2014;71(23):2029-2036. [PubMed 25404594]
  60. Greenspan SL, Nelson JB, Trump DL, Resnick NM. Effect of once-weekly oral alendronate on bone loss in men receiving androgen deprivation therapy for prostate cancer: a randomized trial. Ann Intern Med. 2007;146(6):416-424. [PubMed 17371886]
  61. Greenspan SL, Nelson JB, Trump DL, et al. Skeletal health after continuation, withdrawal, or delay of alendronate in men with prostate cancer undergoing androgen-deprivation therapy. J Clin Oncol. 2008;26(27):4426-4434. [PubMed 18802155]
  62. Gregson CL, Armstrong DJ, Bowden J, et al. UK clinical guideline for the prevention and treatment of osteoporosis. Arch Osteoporos. 2022;17(1):58. doi:10.1007/s11657-022-01061-5 [PubMed 35378630]
  63. Gwynne Jones DP, Savage RL, Highton J. Alendronate-induced synovitis. J Rheumatol. 2008;35(3):537-538. [PubMed 18203307]
  64. Hall SF, Edmonds SW, Lou Y, et al. Patient-reported reasons for nonadherence to recommended osteoporosis pharmacotherapy. J Am Pharm Assoc (2003). 2017;57(4):503-509. doi: 10.1016/j.japh.2017.05.003. [PubMed 28602783]
  65. Hansen T, Kunkel M, Weber A, James Kirkpatrick C. Osteonecrosis of the jaws in patients treated with bisphosphonates - histomorphologic analysis in comparison with infected osteoradionecrosis. J Oral Pathol Med. 2006;35(3):155-160. doi: 10.1111/j.1600-0714.2006.00391.x. [PubMed 16454811]
  66. Hardcastle SA. "Pregnancy and lactation associated osteoporosis". Calcif Tissue Int. 2022;110(5):531-545. doi:10.1007/s00223-021-00815-6 [PubMed 33620518]
  67. Hellstein JW, Adler RA, Edwards B, et al, "Managing the Care of Patients Receiving Antiresorptive Therapy for Prevention and Treatment of Osteoporosis: Executive Summary of Recommendations From the American Dental Association Council on Scientific Affairs," J Am Dent Assoc, 2011, 142(11):1243-51. [PubMed 22041409]
  68. Hellstein JW, Adler RA, Edwards B, et al, "Managing the Care of Patients Receiving Antiresorptive Therapy for Prevention and Treatment of Osteoporosis: Recommendations From the American Dental Association Council on Scientific Affairs," 2011, Available at http://www.ada.org/~/media/ADA/Member%20Center/FIles/topics_ARONJ_report.ashx. Accessed February 2013.
  69. Houston C, Mathews K, Shibli-Rahhal A. Bone density and alendronate effects in Duchenne muscular dystrophy patients. Muscle Nerve. 2014;49(4):506-511. [PubMed 23835890]
  70. Humphrey MB, Russell L, Danila MI, et al. 2022 American College of Rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Rheumatol. 2023;75(12):2088-2102. doi:10.1002/art.42646 [PubMed 37845798]
  71. IOM (Institute of Medicine), Dietary Reference Intakes for Calcium and Vitamin D, Washington, DC: The National Academies Press, 2011.
  72. Jackson C, Freeman ALJ, Szlamka Z, Spiegelhalter DJ. The adverse effects of bisphosphonates in breast cancer: a systematic review and network meta-analysis. PLoS One. 2021;16(2):e0246441. doi:10.1371/journal.pone.0246441 [PubMed 33544765]
  73. Jacobson DL, Lindsey JC, Gordon C, et al. Alendronate improves bone mineral density in children and adolescents perinatally infected with human immunodeficiency virus with low bone mineral density for age. Clin Infect Dis. 2020;71(5):1281-1288. doi:10.1093/cid/ciz957 [PubMed 31573608]
  74. Jara MA, Varghese J, Hu MI. Adverse events associated with bone-directed therapies in patients with cancer. Bone. 2022;158:115901. doi:10.1016/j.bone.2021.115901 [PubMed 33631354]
  75. Jones DG, Savage R, Highton J. Synovitis induced by alendronic acid can present as acute carpal tunnel syndrome. BMJ. 2005;330(7482):74. doi:10.1136/bmj.330.7482.74 [PubMed 15637369]
  76. Kaku T, Oh Y, Sato S, et al. Prevalence of precursory signs of atypical femoral fractures in patients receiving bone-modifying agents for bone metastases: a cross-sectional study. JBMR Plus. 2023;7(7):e10749. doi:10.1002/jbm4.10749 [PubMed 37457876]
  77. Kashyap AS, Kashyap S. Hypoparathyroidism unmasked by alendronate. Postgrad Med J. 2000;76(897):417-418. doi: 10.1136/pmj.76.897.417. [PubMed 10878202]
  78. Katsarelis H, Shah NP, Dhariwal DK, Pazianas M. Infection and medication-related osteonecrosis of the jaw. J Dent Res. 2015;94(4):534-539. doi:10.1177/0022034515572021 [PubMed 25710950]
  79. Khan AA, Kaiser S. Atypical femoral fracture. CMAJ. 2017;189(14):E542. doi:10.1503/cmaj.160450 [PubMed 28396331]
  80. Khan AA, Morrison A, Hanley DA, et al. Diagnosis and management of osteonecrosis of the jaw: a systematic review and international consensus. J Bone Miner Res. 2015; 30(1):3-23. [PubMed 25414052]
  81. Kharazmi M, Sjöqvist K, Rizk M, Warfvinge G. Oral ulcer associated with alendronate: a case report. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010;110(6):e11-13. doi: 10.1016/j.tripleo.2010.04.035. [PubMed 20674418]
  82. Kharazmi M, Sjöqvist K, Warfvinge G. Oral ulcers, a little known adverse effect of alendronate: review of the literature. J Oral Maxillofac Surg. 2012;70(4):830-836. doi: 10.1016/j.joms.2011.03.046. [PubMed 21816532]
  83. Khosla S, Burr D, Cauley J, et al. Bisphosphonate-associated osteonecrosis of the jaw: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2007;22(10):1479-1491. doi:10.1359/jbmr.0707onj [PubMed 17663640]
  84. Kizub DA, Miao J, Schubert MM, et al. Risk factors for bisphosphonate-associated osteonecrosis of the jaw in the prospective randomized trial of adjuvant bisphosphonates for early-stage breast cancer (SWOG 0307). Support Care Cancer. 2021;29(5):2509-2517. doi:10.1007/s00520-020-05748-8 [PubMed 32929540]
  85. Klotz LH, McNeill IY, Kebabdjian M, Zhang L, Chin JL; Canadian Urology Research Consortium. A phase 3, double-blind, randomised, parallel-group, placebo-controlled study of oral weekly alendronate for the prevention of androgen deprivation bone loss in nonmetastatic prostate cancer: the Cancer and Osteoporosis Research with Alendronate and Leuprolide (CORAL) study. Eur Urol. 2013;63(5):927-935. [PubMed 23040208]
  86. Kontoleon P, Ilias I, Stavropoulos PG, Papapetrou PD. Urticaria after administration of alendronate. Acta Derm Venereol. 2000;80(5):398 [PubMed 11200854]
  87. Lanza FL. Gastrointestinal adverse effects of bisphosphonates: etiology, incidence and prevention. Treat Endocrinol. 2002;1(1):37-43. doi:10.2165/00024677-200201010-00004 [PubMed 15765619]
  88. Lenzer J. US drugs regulator issues severe pain alert on bisphosphonates. BMJ. 2008;336(7636):117. doi:10.1136/bmj.39461.527650.4E [PubMed 18202062]
  89. Lethaby C, Wiernikowski J, Sala A, Naronha M, Webber C, Barr RD. Bisphosphonate therapy for reduced bone mineral density during treatment of acute lymphoblastic leukemia in childhood and adolescence: a report of preliminary experience. J Pediatr Hematol Oncol. 2007;29(9):613-616. [PubMed 17805035]
  90. Leung S, Ashar BH, Miller RG. Bisphosphonate-associated scleritis: a case report and review. South Med J. 2005;98(7):733-735. doi:10.1097/01.SMJ.0000152753.80490.9F [PubMed 16108245]
  91. Levy S, Fayez I, Taguchi N, et al, "Pregnancy Outcome Following in utero Exposure to Bisphosphonates," Bone, 2009, 44(3):428-30. [PubMed 19059370]
  92. Lewiecki EM. Prevention of osteoporosis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed June 25, 2021.
  93. Lewiecki EM. Safety of long-term bisphosphonate therapy for the management of osteoporosis. Drugs. 2011;71(6):791-814. doi: 10.2165/11585470-000000000-00000. [PubMed 21504254]
  94. Lin TC, Yang CY, Kao Yang YH, Lin SJ. Incidence and risk of osteonecrosis of the jaw among the Taiwan osteoporosis population. Osteoporos Int. 2014;25(5):1503-1511. doi: 10.1007/s00198-014-2624-6. [PubMed 24515577]
  95. Liu ZM, Zhang M, Zong Y, et al. The efficiency and safety of alendronate versus teriparatide for treatment glucocorticoid-induced osteoporosis: a meta-analysis and systematic review of randomized controlled trials. PLoS One. 2022;17(5):e0267706. doi:10.1371/journal.pone.0267706 [PubMed 35639783]
  96. Lo JC, O'Ryan FS, Gordon NP, et al. Prevalence of Osteonecrosis of the Jaw in Patients With Oral Bisphosphonate Exposure. J Oral Maxillofac Surg. 2010;68(2):243-253. [PubMed 19772941]
  97. Lockwood M, Banderudrappagari R, Suva LJ, Makhoul I. Atypical femoral fractures from bisphosphonate in cancer patients - Review. J Bone Oncol. 2019;18:100259. doi: 10.1016/j.jbo.2019.100259. [PubMed 31497503]
  98. Maalouf NM, Heller HJ, Odvina CV, Kim PJ, Sakhaee K. Bisphosphonate-induced hypocalcemia: report of 3 cases and review of literature. Endocr Pract. 2006;12(1):48-53. doi: 10.4158/EP.12.1.48. [PubMed 16524863]
  99. MacDonald P, Cranston A, Virdee M, Farncombe T, Athale U, Barr RD. Safety and efficacy of alendronate to treat osteopenia in children during therapy for acute lymphoblastic leukemia: a retrospective cohort study of sequential outcomes. J Pediatr Hematol Oncol. 2023;45(4):200-206. doi:10.1097/MPH.0000000000002606 [PubMed 36729669]
  100. Machairiotis N, Ntali G, Kouroutou P, Michala L. Clinical evidence of the effect of bisphosphonates on pregnancy and the infant. Horm Mol Biol Clin Investig. 2019;40(2). doi:10.1515/hmbci-2019-0021 [PubMed 31539355]
  101. Malik AR, Campbell SH, Toma NM. Bilateral acute anterior uveitis after alendronate. Br J Ophthalmol. 2002;86(12):1443. doi:10.1136/bjo.86.12.1443 [PubMed 12446386]
  102. Marchand D, Loshak H. Duration of Bisphosphonate Treatment for Patients with Osteoporosis: A Review of Clinical Effectiveness and Guidelines. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; October 4, 2019. [PubMed 31893493]
  103. Marx RE. Pamidronate (Aredia) and zoledronate (Zometa) induced avascular necrosis of the jaws: a growing epidemic. J Oral Maxillofac Surg. 2003;61(9):1115-1117. doi: 10.1016/s0278-2391(03)00720-1. [PubMed 12966493]
  104. Marx RE, Sawatari Y, Fortin M, Broumand V. Bisphosphonate-induced exposed bone (osteonecrosis/osteopetrosis) of the jaws: risk factors, recognition, prevention, and treatment. J Oral Maxillofac Surg. 2005;63(11):1567-1575. doi: 10.1016/j.joms.2005.07.010. [PubMed 16243172]
  105. Mavrokokki T, Cheng A, Stein B, et al, “Nature and Frequency of Bisphosphonate-Associated Osteonecrosis of the Jaws in Australia,” J Oral Maxillofac Surg, 2007, 65(3):415-23. [PubMed 17307586]
  106. Miller PD, McClung MR, Macovei L, et al. Monthly oral ibandronate therapy in postmenopausal osteoporosis: 1-year results from the MOBILE study. J Bone Miner Res. 2005;20(8):1315-1322. doi:10.1359/JBMR.050313 [PubMed 16007327]
  107. Modi A, Siris ES, Steve Fan CP, Sajjan S. Gastrointestinal events among patients initiating osteoporosis therapy: A retrospective administrative claims database analysis. Clin Ther. 2015;37(6):1228-1234. doi: 10.1016/j.clinthera.2015.03.018. [PubMed 25866298]
  108. Modi A, Sajjan S, Michael Lewiecki E, Harris ST, Papadopoulos Weaver J. Relationship between gastrointestinal events and compliance with osteoporosis therapy: an administrative claims analysis of the US managed care population. Clin Ther. 2016;38(5):1074-1080. doi:10.1016/j.clinthera.2016.03.027 [PubMed 27112533]
  109. Munigoti S, Frazer R, Rees A, Blackshaw G, Thomas G, Roberts A. A rare complication with a single dose of alendronate. BMJ Case Rep. 2010;2010:bcr0220102738. doi: 10.1136/bcr.02.2010.2738. [PubMed 22778283]
  110. Nakhla M, Denker AE, Connor JD, et al. Bioavailability and short-term tolerability of alendronate in glucocorticoid-treated children. Clin Ther. 2011;33(10):1516-1523. [PubMed 21962451]
  111. Nicolatou-Galitis O, Schiødt M, Mendes RA, et al. Medication-related osteonecrosis of the jaw: definition and best practice for prevention, diagnosis, and treatment. Oral Surg Oral Med Oral Pathol Oral Radiol. 2019;127(2):117-135. doi: 10.1016/j.oooo.2018.09.008. [PubMed 30393090]
  112. North American Menopause Society. Management of osteoporosis in postmenopausal women: the 2021 position statement of The North American Menopause Society. Menopause. 2021;28(9):973-997. doi:10.1097/GME.0000000000001831 [PubMed 34448749]
  113. O'Mahony D, Cherubini A, Guiteras AR, et al. STOPP/START criteria for potentially inappropriate prescribing in older people: version 3. Eur Geriatr Med. 2023;14(4):625-632. doi:10.1007/s41999-023-00777-y [PubMed 37256475]
  114. Ornoy A, Wajnberg R, Diav-Citrin O. The outcome of pregnancy following pre-pregnancy or early pregnancy alendronate treatment. Reprod Toxicol. 2006;22(4):578-579. [PubMed 16996245]
  115. Palomo T, Vilaça T, Lazaretti-Castro M. Osteogenesis imperfecta: diagnosis and treatment. Curr Opin Endocrinol Diabetes Obes. 2017;24(6):381-388. doi:10.1097/MED.0000000000000367 [PubMed 28863000]
  116. Papapetrou PD. Bisphosphonate-associated adverse events. Hormones (Athens). 2009;8(2):96-110. doi:10.14310/horm.2002.1226 [PubMed 19570737]
  117. Parés A, Guañabens N. Osteoporosis in primary biliary cirrhosis: pathogenesis and treatment. Clin Liver Dis. 2008;12(2):407-x. doi:10.1016/j.cld.2008.02.005 [PubMed 18456188]
  118. Park-Wyllie LY, Mamdani MM, Juurlink DN, et al. Bisphosphonate use and the risk of subtrochanteric or femoral shaft fractures in older women. JAMA. 2011;305(8):783-789. doi: 10.1001/jama.2011.190. [PubMed 21343577]
  119. Paul AK, Seetharaman M. Esophageal stricture associated with alendronate use. CMAJ. 2011;183(7):E429. doi: 10.1503/cmaj.100415. [PubMed 21343270]
  120. Penning-van Beest FJ, Goettsch WG, Erkens JA, Herings RM. Determinants of persistence with bisphosphonates: a study in women with postmenopausal osteoporosis. Clin Ther. 2006;28(2):236-242. doi: 10.1016/j.clinthera.2006.01.002. [PubMed 16678644]
  121. Pepe J, Body JJ, Hadji P, et al. Osteoporosis in premenopausal women: a clinical narrative review by the ECTS and the IOF. J Clin Endocrinol Metab. 2020;105(8):dgaa306. doi:10.1210/clinem/dgaa306 [PubMed 32453819]
  122. Pereira RM, Carvalho JF, Paula AP, et al, "Guidelines for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis," Rev Bras Reumatol, 2012, 52(4):580-93. [PubMed 22885424]
  123. Pizones J, Plotkin H, Parra-Garcia JI, et al. Bone healing in children with osteogenesis imperfecta treated with bisphosphonates. J Pediatr Orthop. 2005;25(3):332-335. [PubMed 15832149]
  124. Qian Y, Wang L, Yu L, Huang W. Pregnancy- and lactation-associated osteoporosis with vertebral fractures: a systematic review. BMC Musculoskelet Disord. 2021;22(1):926. doi:10.1186/s12891-021-04776-7 [PubMed 34732196]
  125. Ralston SH, Corral-Gudino L, Cooper C, et al. Diagnosis and management of Paget's disease of bone in adults: a clinical guideline. J Bone Miner Res. 2019;34(4):579-604. doi: 10.1002/jbmr.3657. [PubMed 30803025]
  126. Rauch F, Glorieux FH. Osteogenesis imperfecta. Lancet. 2004;363(9418):1377-1385. [PubMed 15110498]
  127. Rauch F, Travers R, Glorieux FH. Pamidronate in children with osteogenesis imperfecta: histomorphometric effects of long-term therapy. J Clin Endocrinol Metab. 2006;91(2):511-516. [PubMed 16291701]
  128. Refer to manufacturer's labeling.
  129. Richmond BK. Profound refractory hypocalcemia after thyroidectomy in a patient receiving chronic oral bisphosphonate therapy. Am Surg. 2005;71(10):872-873. [PubMed 16468539]
  130. Rosen HN, Drezner MK. Overview of the management of osteoporosis in postmenopausal women. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed November 4, 2021a.
  131. Rosen HN, Saag KG. Prevention and treatment of glucocorticoid-induced osteoporosis. Connor RF, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed March 25, 2024.
  132. Rossi V, Lee B, Marom R. Osteogenesis imperfecta: advancements in genetics and treatment. Curr Opin Pediatr. 2019;31(6):708-715. doi:10.1097/MOP.0000000000000813 [PubMed 31693577]
  133. Ruggiero S, Gralow J, Marx RE, et al. Practical guidelines for the prevention, diagnosis, and treatment of osteonecrosis of the jaw in patients with cancer. J Clin Oncol. 2006. 2(1):7-14. doi: 10.1200/JOP.2006.2.1.7. [PubMed 20871729]
  134. Ruggiero SL, Dodson TB, Aghaloo T, Carlson ER, Ward BB, Kademani D. American Association of Oral and Maxillofacial Surgeons' position paper on medication-related osteonecrosis of the jaws – 2022 update. J Oral Maxillofac Surg. 2022;80(5):920-943. doi:10.1016/j.joms.2022.02.008 [PubMed 35300956]
  135. Saag KG, Emkey R, Schnitzer TJ, et al, Alendronate for the prevention and treatment of glucocorticoid-induced osteoporosis. Glucocorticoid-Induced Osteoporosis Intervention Study Group. N Engl J Med. 1998;339(5):292-299. [PubMed 9682041]
  136. Saylor PJ, Rumble RB, Tagawa S, et al. Bone health and bone-targeted therapies for prostate cancer: ASCO endorsement of a Cancer Care Ontario guideline. J Clin Oncol. 2020;38(15):1736-1743. doi:10.1200/JCO.19.03148 [PubMed 31990618]
  137. Schussheim DH, Jacobs TP, Silverberg SJ. Hypocalcemia associated with alendronate. Ann Intern Med. 1999;130(4 pt 1):329. doi: 10.7326/0003-4819-130-4-199902160-00008. [PubMed 10068397]
  138. Seikaly MG, Kopanati S, Salhab N, et al. Impact of alendronate on quality of life in children with osteogenesis imperfecta. J Pediatr Orthop. 2005;25(6):786-791. [PubMed 16294137]
  139. Shane E, Burr D, Ebeling PR, et al. Atypical subtrochanteric and diaphyseal femoral fractures: report of a task force of the American Society for Bone and Mineral Research [published correction appears in J Bone Miner Res. 2011 Aug;26(8):1987]. J Bone Miner Res. 2010;25(11):2267-2294. doi:10.1002/jbmr.253 [PubMed 20842676]
  140. Shane E, Burr D, Abrahamsen B, et al. Atypical subtrochanteric and diaphyseal femoral fractures: second report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2014;29(1):1-23. doi:10.1002/jbmr.1998. [PubMed 23712442]
  141. Shapiro CL, Van Poznak C, Lacchetti C, et al. Management of osteoporosis in survivors of adult cancers with nonmetastatic disease: ASCO clinical practice guideline. J Clin Oncol. 2019;37(31):2916-2946. doi:10.1200/JCO.19.01696 [PubMed 31532726]
  142. Simm PJ, Biggin A, Zacharin MR, et al. Consensus guidelines on the use of bisphosphonate therapy in children and adolescents. J Paediatr Child Health. 2018;54(3):223-233. doi:10.1111/jpc.13768 [PubMed 29504223]
  143. Singer FR 3rd, Bone HG, Hosking DJ, et al; Endocrine Society. Paget's disease of bone: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2014;99(12):4408-4422. [PubMed 25406796]
  144. Smith MR. Side effects of androgen deprivation therapy. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed July 5, 2022.
  145. Sokal A, Elefant E, Leturcq T, Beghin D, Mariette X, Seror R. Pregnancy and newborn outcomes after exposure to bisphosphonates: a case-control study. Osteoporos Int. 2019;30(1):221-229. [PubMed 30171300]
  146. Stathopoulos IP, Liakou CG, Katsalira A, et al, "The Use of Bisphosphonates in Women Prior to or During Pregnancy and Lactation," Hormones (Athens)', 2011, 10(4):280-91. [PubMed 22281884]
  147. Stoch SA, Saag KG, Greenwald M, et al. Once-weekly oral alendronate 70 mg in patients with glucocorticoid-induced bone loss: a 12-month randomized, placebo-controlled clinical trial. J Rheumatol. 2009;36(8):1705-1714. doi: 10.3899/jrheum.081207. [PubMed 19487264]
  148. Tadrous M, Wong L, Mamdani MM, et al. Comparative gastrointestinal safety of bisphosphonates in primary osteoporosis: a network meta-analysis. Osteoporos Int. 2014;25(4):1225-1235. doi:10.1007/s00198-013-2576-2 [PubMed 24287510]
  149. Tee SI, Yosipovitch G, Chan YC, et al. Prevention of glucocorticoid-induced osteoporosis in immunobullous diseases with alendronate: a randomized, double-blind, placebo-controlled study. Arch Dermatol. 2012;148(3):307-314. doi: 10.1001/archdermatol.2011.354. [PubMed 22105813]
  150. Tosteson AN, Grove MR, Hammond CS, et al. Early discontinuation of treatment for osteoporosis. Am J Med. 2003;115(3):209-216. doi: 10.1016/s0002-9343(03)00362-0. [PubMed 12947959]
  151. Toussaint ND, Lau KK, Strauss BJ, Polkinghorne KR, Kerr PG. Effect of alendronate on vascular calcification in CKD stages 3 and 4: a pilot randomized controlled trial. Am J Kidney Dis. 2010;56(1):57-68. doi:10.1053/j.ajkd.2009.12.039 [PubMed 20347511]
  152. Ugurlar M. Alendronate- and risedronate-induced acute polyarthritis. Osteoporos Int. 2016;27(11):3383-3385. doi:10.1007/s00198-016-3695-3 [PubMed 27376840]
  153. Unal E, Abaci A, Bober E, Büyükgebiz A. Efficacy and safety of oral alendronate treatment in children and adolescents with osteoporosis. J Pediatr Endocrinol Metab. 2006;19(4):523-528. [PubMed 16759038]
  154. US Food and Drug Administration (FDA). Information for healthcare professionals: bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa). FDA alert January 7, 2008. Accessed August 27, 2024.
  155. Van den Wyngaert T, Huizing MT, Vermorken JB. Bisphosphonates and osteonecrosis of the jaw: cause and effect or a post hoc fallacy? Ann Oncol. 2006;17(8):1197-1204. doi:10.1093/annonc/mdl294 [PubMed 16873439]
  156. Vestergaard P, Schwartz K, Rejnmark L, Mosekilde L, Pinholt EM. Oral bisphosphonate use increases the risk for inflammatory jaw disease: a cohort study. J Oral Maxillofac Surg. 2012;70(4):821-829. doi: 10.1016/j.joms.2011.02.093. [PubMed 21764202]
  157. Wang Q, Yu Q, Zeng P, Ai W. Efficacy and safety of annual infusion of zoledronic acid and weekly oral alendronate in the treatment of primary osteoporosis: a meta-analysis. J Clin Pharmacol. 2023;63(4):455-465. doi:10.1002/jcph.2181 [PubMed 36433675]
  158. Ward LM, Rauch F, Whyte MP, et al. Alendronate for the treatment of pediatric osteogenesis imperfect: a randomized placebo-controlled study. J Clin Endocrinol Metab. 2011;96(2):355-364. [PubMed 21106710]
  159. Watts NB, Adler RA, Bilezikian JP, et al; Endocrine Society. Osteoporosis in men: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2012;97(6):1802-1822. doi: 10.1210/jc.2011-3045. [PubMed 22675062]
  160. Watts NB, Diab DL. Long-term use of bisphosphonates in osteoporosis. J Clin Endocrinol Metab. 2010;95(4):1555-1565. doi: 10.1210/jc.2009-1947. [PubMed 20173017]
  161. Wysowski DK, Chang JT. Alendronate and risedronate: reports of severe bone, joint, and muscle pain. Arch Intern Med. 2005;165(3):346-347. doi:10.1001/archinte.165.3.346-b [PubMed 15710802]
  162. Yamamoto K, Kishino M, Nakamura S, Tokushige K. Symptoms and upper gastrointestinal mucosal injury associated with bisphosphonate therapy. Intern Med. 2019;58(8):1049-1056. doi:10.2169/internalmedicine.1271-18 [PubMed 30626809]
  163. Yarom N, Shapiro CL, Peterson DE, et al. Medication-related osteonecrosis of the jaw: MASCC/ISOO/ASCO clinical practice guideline. J Clin Oncol. 2019;37(25):2270-2290. doi:10.1200/JCO.19.01186 [PubMed 31329513]
  164. Yeap SS, Fauzi AR, Kong NC, et al. A comparison of calcium, calcitriol, and alendronate in corticosteroid-treated premenopausal patients with systemic lupus erythematosus. J Rheumatol. 2008;35(12):2344-2347. doi: 10.3899/jrheum.080634. [PubMed 19004038]
  165. Yuan C, Liang Y, Zhu K, Xie W. Clinical efficacy of denosumab, teriparatide, and oral bisphosphonates in the prevention of glucocorticoid-induced osteoporosis: a systematic review and meta-analysis. J Orthop Surg Res. 2023;18(1):447. doi:10.1186/s13018-023-03920-4 [PubMed 37349750]
  166. Yurci A, Kalkan AO, Ozbakir O, et al. Efficacy of different therapeutic regimens on hepatic osteodystrophy in chronic viral liver disease. Eur J Gastroenterol Hepatol. 2011;23(12):1206-1212. doi:10.1097/MEG.0b013e32834cd6f6 [PubMed 21971374]
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