Version October 2024
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 low BMD (T-scores between −1 and −2.5 in either group) and expected to receive systemic glucocorticoid therapy for at least 3 months at a prednisone dose of ≥7.5 mg/day (or its equivalent) or in any patient whose baseline risk of fracture is high and is receiving a glucocorticoid at any dose or duration (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 (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 (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.
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).
No dosage adjustment necessary.
Refer to adult dosing.
(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: 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:
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 (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.
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.
There are no pediatric-specific recommendations provided in the manufacturer's labeling; based on experience in adult patients, no adjustment required.
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 alendronate for at least 5 years (Ref). Patients may experience prodromal pain weeks or months before the fracture occurs (Ref).
Risk factors:
• Long-term treatment (>3 to 5 years) (Ref)
• Asian race (in North America) (Ref)
• Femoral bowing (Ref)
• Glucocorticoid use (>1 year) (Ref)
Esophagitis, dysphagia, esophageal ulcer, erosive esophagitis, esophageal stenosis (rare), and esophageal perforation (rare) (Ref) have been reported. 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) (Ref)
• Older adults (Ref)
• Concurrent nonsteroidal anti-inflammatory drug or antithrombotic use (Ref)
• Prior GI issues (Ref)
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). This has been seen in the setting of a known or unknown diagnosis of hypoparathyroidism and is reversible with discontinuation of alendronate, regardless of cause.
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)
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; 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)
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)
|
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 (≤1%) (table 2), esophageal ulcer (≤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%)
|
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 |
|
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 (≤6%; includes bone pain, joint pain, and muscle pain)
<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) (Maalouf 2006)
Gastrointestinal: Duodenal ulcer (may be severe with complications), erosive esophagitis (de Groen 1996), esophageal perforation (Munigoti 2010), esophageal stenosis (Aibar Arregui 2011), esophagitis (de Groen 1996)
Hypersensitivity: Hypersensitivity reaction (includes angioedema and urticaria) (Kontoleon 2000)
Nervous system: Dizziness, malaise, vertigo
Neuromuscular & skeletal: Asthenia, femur fracture (low-energy fractures, including atypical subtrochanteric and diaphyseal) (Park-Wyllie 2011), joint swelling, osteonecrosis (cholesteatoma of the external auditory canal), osteonecrosis of the jaw (rare: <1%) (Lewiecki 2011)
Ophthalmic: Episcleritis, scleritis (Leung 2005), uveitis (Malik 2002)
Respiratory: Exacerbation of asthma, oropharyngeal ulcer (Kharazmi 2012)
Miscellaneous: Fever
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
Concerns related to adverse effects:
• Bone/joint/muscle pain: Severe (and occasionally debilitating) bone, joint, and/or muscle pain have been reported during bisphosphonate treatment. The onset of pain ranged from a single day to several months. Consider discontinuing therapy in patients who experience severe symptoms; symptoms usually resolve upon discontinuation. Some patients experienced recurrence when rechallenged with the same drug or another bisphosphonate; avoid use in patients with a history of these symptoms in association with bisphosphonate therapy.
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.
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).
Alendronate 40 mg tablets have been discontinued in the US for more than 1 year.
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
May be product dependent
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): $44.09
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.
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
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.
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.
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
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.
Osteoporosis, glucocorticoid-induced, prevention; Prostate cancer, bone loss associated with androgen deprivation therapy
Alendronate may be confused with risedronate
Fosamax may be confused with Flomax, Fosamax Plus D, fosinopril, Zithromax
Fosamax [US, Canada, and multiple international markets] may be confused with Fisamox brand name for amoxicillin [Australia]
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).
None known.
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 enhance the hypocalcemic effect of Bisphosphonate Derivatives. Aminoglycosides may enhance the nephrotoxic effect of Bisphosphonate Derivatives. Risk C: Monitor therapy
Angiogenesis Inhibitors (Systemic): May enhance the adverse/toxic effect of Bisphosphonate Derivatives. Specifically, the risk for osteonecrosis of the jaw may be increased. Risk C: Monitor therapy
Aspirin: May enhance the adverse/toxic effect of Alendronate. Specifically, the incidence of upper gastrointestinal adverse events may be increased Risk C: Monitor therapy
Deferasirox: Bisphosphonate Derivatives may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy
Inhibitors of the Proton Pump (PPIs and PCABs): May diminish the therapeutic effect of Bisphosphonate Derivatives. Risk C: Monitor therapy
Nonsteroidal Anti-Inflammatory Agents: May enhance the adverse/toxic effect of Bisphosphonate Derivatives. Both an increased risk of gastrointestinal ulceration and an increased risk of nephrotoxicity are of concern. Risk C: Monitor therapy
Parathyroid Hormone: Alendronate may diminish the therapeutic effect of Parathyroid Hormone. More specifically, Alendronate may interfere with normalization of blood calcium concentrations. Risk X: Avoid combination
Polyvalent Cation Containing Products: May decrease the 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
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.
Underlying causes of osteoporosis should be evaluated and treated prior to considering bisphosphonate therapy in premenopausal women; effective contraception is recommended when bisphosphonate therapy is required (Pepe 2020). Bisphosphonates are incorporated into the bone matrix and gradually released over time. Because exposure prior to pregnancy may theoretically increase the risk of fetal harm, most sources recommend discontinuing bisphosphonate therapy in females of reproductive potential as early as possible prior to a planned pregnancy. Use in premenopausal females should be reserved for special circumstances when rapid bone loss is occurring; a bisphosphonate with the shortest half-life should then be used (Bhalla 2010; Pereira 2012; Stathopoulos 2011).
Oral bisphosphonates can be considered for the prevention of glucocorticoid-induced osteoporosis in premenopausal females with moderate to high risk of fracture who do not plan to become pregnant during the treatment period and who are using effective birth control (or are not sexually active); intravenous therapy should be reserved for high risk patients only (Buckley [ACR 2017]).
It is not known if bisphosphonates cross the placenta, but based on their lower molecular weight, fetal exposure is expected (Djokanovic 2008; Stathopoulos 2011).
Information related to the use of alendronate in pregnancy is available from case reports and small retrospective studies (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).
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.
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).
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 [Buckley 2017]); 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).
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.
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)
Altered kidney function: Elimination may be reduced.
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