Medically reviewed by Drugs.com. Last updated on Apr 2, 2019.
(a LEN droe nate)
- Alendronate Sodium
- Alendronic Acid Monosodium Salt Trihydrate
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Generic: 70 mg/75 mL (75 mL)
Fosamax: 70 mg
Generic: 5 mg, 10 mg, 35 mg, 40 mg, 70 mg
Tablet Effervescent, Oral:
Binosto: 70 mg
Brand Names: U.S.
- Bisphosphonate Derivative
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.
28 L (exclusive of bone)
Urine; feces (as unabsorbed drug)
Exceeds 10 years
Special Populations: Renal Function Impairment
Elimination may be reduced.
Use: Labeled Indications
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 males and females with low bone mineral density who are receiving a daily dosage ≥7.5 mg of prednisone (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
Off Label Uses
Bone loss associated with androgen deprivation therapy in prostate cancer (prevention)
Data from a randomized, double-blind, placebo-controlled crossover study supports the use of once weekly alendronate (in conjunction with calcium and vitamin D supplementation) for the prevention of bone loss associated with androgen deprivation therapy in prostate cancer [Greenspan 2007], [Greenspan 2008]. Data from a multicenter randomized, double-blind, placebo-controlled study also supports the use of weekly alendronate (in conjunction with calcium and vitamin D supplementation) for prevention of androgen deprivation therapy-associated bone loss [Klotz 2013].
Glucocorticoid-induced osteoporosis (prevention)
Based on the 2017 American College of Rheumatology Guideline for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis, bisphosphonates (including alendronate) are effective and recommended for prevention of glucocorticoid-induced osteoporosis in women (not of childbearing potential, or who do not plan to become pregnant) and men with moderate to high fracture risk and who are initiating long-term glucocorticoid treatment (ACR [Buckley 2017]).
Data from a randomized, placebo-controlled clinical study supports the use of alendronate in the prevention of glucocorticoid-induced osteoporosis [Saag 1998].
Limited initial data from small controlled and noncontrolled trials suggest that oral alendronate may be a cost-effective alternative to IV therapy in the treatment of osteogenesis imperfecta in adults. Larger, controlled trials are needed to verify initial results regarding alendronate's effects on BMD and to detect its effects on fracture rates in the treatment of osteogenesis imperfecta.
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 creatinine clearance <35 mL/minute
Documentation of allergenic cross-reactivity for bisphosphonates is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Note: The optimal duration of osteoporosis treatment has not been determined. In postmenopausal women with low fracture risk, consider a drug holiday after 5 years of oral bisphosphonate therapy. In postmenopausal women who remain at high fracture risk, consider extending treatment for up to 10 years (AACE/ACE [Camacho 2016]; Adler 2016). Although evidence is limited, applying these recommendations to treatment duration in older men may be considered (Adler 2016). Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.
Osteoporosis in postmenopausal females: Oral:
Prophylaxis: 5 mg once daily or 35 mg once weekly
Treatment: 10 mg once daily or 70 mg once weekly
Osteoporosis in males (to increase bone mass): Oral: Treatment: 10 mg once daily or 70 mg once weekly
Osteoporosis secondary to glucocorticoids in males and females: Oral:
Treatment: 5 mg once daily; a dose of 10 mg once daily should be used in postmenopausal females who are not receiving estrogen.
Prevention (off-label use): 5 mg once daily; a dose of 10 mg once daily should be used in postmenopausal females who are not receiving estrogen (Saag 1998). Note: Use is not recommended in women who are pregnant or who plan on becoming pregnant (ACR [Buckley 2017]).
Paget disease of bone in males and females: Oral: 40 mg once daily for 6 months
Re-treatment: Following a 6-month post-treatment evaluation period, treatment with alendronate may be considered in patients who have relapsed based on increases in serum alkaline phosphatase, which should be measured periodically. Re-treatment may also be considered in those who failed to normalize their serum alkaline phosphatase. The Endocrine Society guidelines suggest re-treatment may be required between 2 and 6 years (Singer 2014).
Missed doses (once weekly): If a once-weekly dose is missed, it should be given the next morning after remembered; may then return to the original once-weekly schedule (original scheduled day of the week), however, do not give 2 doses on the same day.
Bone loss associated with androgen deprivation therapy in prostate cancer, prevention (off-label use): Oral: 70 mg once weekly (Greenspan 2007; Greenspan 2008; Klotz 2013)
Osteogenesis imperfecta (off-label use): Oral: 10 mg once daily (Chevrel 2006) or 70 mg once weekly (Shapiro 2010; Xu 2016).
Refer to adult dosing.
Note: Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.
Osteogenesis imperfecta: Limited data available, dosing regimens and efficacy results variable (Akcay 2008; Pizones 2005; Seikaly 2005; Ward 2011): 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
Dosing based on several prospective and retrospective trials; most smaller studies reported increased bone mineral density (BMD), decreased frequency of fractures, alleviation of chronic pain, and in some patients increased mobility (Akcay 2008; Pizones 2005; Seikaly2005; Unal 2005; Vyskocil 2005). The largest trial, a multicenter, randomized, placebo-controlled trial (n=109 in treatment group, n=83 completed 2-year follow-up) reported significant increases in lumbar spine BMD; however, other efficacy markers including long-bone fracture rate and pediatric disability score were no different than placebo (Ward 2011).
Osteopenia associated with cystic fibrosis (CF): Limited data available: Children ≥5 years and Adolescents: Oral:
≤25 kg: 5 mg once daily
>25 kg: 10 mg once daily
Dosing based on a randomized, placebo-controlled trial of CF patients (n=128, treatment group: n=65) with low apparent BMD age and inadequate response to calcium and calcifediol treatment; results showed a significant increase in BMD (16.3% vs 3.1% from baseline); evaluation of effect on fracture rate not possible due to sample size and duration (trial duration: 2 years); alendronate appeared to be well-tolerated with no notable difference in adverse effects reported (Bianchi 2013)
Osteopenia, nonambulatory patients (eg, cerebral palsy, muscular dystrophy): Limited data available, efficacy results variable: Note: Due to added complexity of administration requirements (eg, remaining in an upright position for an extended time) weekly dosing is preferred in these patients.
Fixed dosing (Apkon 2008; Houston 2014; Sholas 2005): Children ≥6 years and Adolescents: Oral: Usual reported dose: 35 mg once weekly. Dosing based on experience in 42 patients (age range: 6 to 16 years) from two case series and a retrospective trial. In the retrospective cohort study (n=29 mean age: 12 years), treatment showed a non-statistically significant trend in Z-score stabilization (Houston 2014). A case series of 10 patients (age range: 6 to 16 years) reported fewer fractures after treatment started compared to the prior year; alendronate was reported as being well tolerated; one patient discontinued therapy for hematemesis (also receiving high-dose ibuprofen therapy) (Sholas 2005).
Weight-directed dosing: Children ≥3 years and Adolescents: Oral: 1 mg/kg/dose once weekly (Paksu 2012); if using a solid dosage form, consider dose rounding to the nearest 10 mg (up or down as appropriate) (Lethaby 2007). Dosing based on a prospective trial of 26 patients (age range: 3 to 17 years); results showed after one year of treatment, increased BMD and decreased alkaline phosphatase.
Osteopenia/Osteoporosis, rheumatology patients (eg, JIA, SLE, dermatomyositis): Limited data available: Children ≥4 years and Adolescents:
≤20 kg: Oral: 5 mg once daily
>20 kg to 30 kg: Oral: 5 or 10 mg once daily
>30 kg: Oral: 10 mg once daily
Dosing based on a prospective trial (multicenter and single center) (Bianchi 2000; Cimaz 2002; Unal 2006); results from trials showed bone mineral density (BMD) was significantly increased (to normal values in some patients) after alendronate therapy; in some cases, bone turnover markers were reduced without a reduction of inflammatory activity (underlying rheumatologic disease process)
Tablet, effervescent (Binosto): Dissolve effervescent tablet in 120 mL of room temperature plain water (not mineral water or flavored water); wait ≥5 minutes after effervescence stops, then stir for 10 seconds and administer.
Oral: Administer first thing in the morning and at least 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 at least 30 minutes and until after first food of the day (to reduce esophageal irritation).
Oral solution: Administer oral solution, followed 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.
Tablet, effervescent (Binosto): 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.
Ensure adequate calcium and vitamin D intake; if dietary intake is inadequate, dietary supplementation is recommended. Women and men should consume:
Calcium: 1,000 mg/day (men: 50 to 70 years) or 1,200 mg/day (women ≥51 years and men ≥71 years) (IOM 2011; NOF [Cosman 2014])
Vitamin D: 800 to 1,000 int. units/day (men and women ≥50 years) (NOF [Cosman 2014]). Recommended Dietary Allowance (RDA): 600 int. units daily (men and women ≤70 years) or 800 int. units/day (men and women ≥71 years) (IOM 2011).
Oral solution: Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze.
Tablet (Fosamax): Store at room temperature of 15°C to 30°C (59°F to 86°F). Keep in well-closed container.
Tablet, effervescent (Binosto): Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture. Store in original blister package until use.
Aminoglycosides: May enhance the hypocalcemic effect of Bisphosphonate Derivatives. 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. Monitor therapy
Aspirin: May enhance the adverse/toxic effect of Alendronate. Specifically, the incidence of upper gastrointestinal adverse events may be increased 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. 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. Monitor therapy
Parathyroid Hormone: Alendronate may diminish the therapeutic effect of Parathyroid Hormone. More specifically, Alendronate may interfere with normalization of blood calcium concentrations. 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. Consider therapy modification
Proton Pump Inhibitors: May diminish the therapeutic effect of Bisphosphonate Derivatives. Monitor therapy
Bisphosphonates may interfere with diagnostic imaging agents such as technetium-99m-diphosphonate in bone scans.
Note: Incidence of adverse effects (mostly GI) increases significantly in patients treated for Paget disease at 40 mg/day.
>10%: Endocrine & metabolic: Decreased serum calcium (18%; transient, mild)
1% to 10%:
Central nervous system: Headache (3%)
Endocrine & metabolic: Decreased serum phosphate (10%; transient, mild)
Gastrointestinal: Abdominal pain (2% to 7%), acid regurgitation (1% to 5%), flatulence (≤4%), gastroesophageal reflux disease (3%), constipation (≤3%), diarrhea (≤3%), dyspepsia (1% to 3%), nausea (1% to 3%), esophageal ulcer (2%), dysphagia (1%), melena (1%), abdominal distension (≤1%), gastric ulcer (≤1%; may be severe with complications), gastritis (≤1%)
Neuromuscular & skeletal: Musculoskeletal pain (≤6%; includes bone pain, joint pain, and muscle pain), muscle cramps (≤1%)
<1%, postmarketing, and/or case reports: Alopecia, conjunctivitis, dizziness, duodenal ulcer (may be severe with complications), dysgeusia, episcleritis, erythema, erosive esophagitis, esophageal perforation, esophageal stenosis, esophageal ulcer, esophagitis, exacerbation of asthma, femur fracture (low-energy fractures, including subtrochanteric and diaphyseal), fever, hypersensitivity reaction (includes angioedema and urticaria), hypocalcemia (symptomatic), joint swelling, malaise, oropharyngeal ulcer; osteonecrosis of the jaw, peripheral edema, pruritus, scleritis, skin rash (occasionally with photosensitivity), Stevens-Johnson syndrome, toxic epidermal necrolysis, uveitis, vertigo, weakness
Concerns related to adverse effects:
• Bone fractures: Atypical femur fractures (AFF) have been reported in patients receiving bisphosphonates. The fractures include subtrochanteric femur (bone just below the hip joint) and diaphyseal femur (long segment of the thigh bone). Some patients experience prodromal pain weeks or months before the fracture occurs. It is unclear if bisphosphonate therapy is the cause for these fractures; atypical femur fractures have also been reported in patients not taking bisphosphonates, and in patients receiving glucocorticoids. Patients receiving long-term (>3 to 5 years) bisphosphonate therapy may be at an increased risk (Adler 2016; NOF [Cosman 2014]); however, benefits of therapy (when used for osteoporosis) generally outweigh absolute risk of AFF within the first 5 years of treatment (Adler 2016). Patients presenting with thigh or groin pain with a history of receiving bisphosphonates should be evaluated for femur fracture. Consider interrupting bisphosphonate therapy in patients who develop a femoral shaft fracture; assess for fracture in the contralateral limb.
• 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 same drug or another bisphosphonate; avoid use in patients with a history of these symptoms in association with bisphosphonate therapy.
• Gastrointestinal mucosa irritation: May cause irritation to upper gastrointestinal mucosa. Esophagitis, dysphagia, esophageal ulcers, esophageal erosions, and esophageal stricture (rare) have been reported with oral bisphosphonates; risk increases in patients unable to comply with dosing instructions. Use with caution in patients with dysphagia, esophageal disease, gastritis, duodenitis, or ulcers (may worsen underlying condition). Discontinue use if new or worsening symptoms develop.
• Hypocalcemia: Hypocalcemia has been reported with the use of bisphosphonates. Prior to therapy initiation, hypocalcemia must be corrected; ensure adequate calcium and vitamin D intake.
• Ocular effects: Conjunctivitis, uveitis, episcleritis, and scleritis have been reported with alendronate; patients presenting with signs of ocular inflammation may require further ophthalmologic evaluation.
• Osteonecrosis of the jaw: Osteonecrosis of the jaw (ONJ), also referred to as medication-related osteonecrosis of the jaw (MRONJ), has been reported in patients receiving bisphosphonates. Known risk factors for MRONJ include invasive dental procedures (eg, tooth extraction, dental implants, boney surgery), cancer diagnosis, concomitant therapy (eg, chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, ill-fitting dentures, and comorbid disorders (anemia, coagulopathy, infection, preexisting dental or periodontal disease). Risk may increase with increased duration of bisphosphonate use. According to a position paper by the American Association of Maxillofacial Surgeons (AAOMS), MRONJ has been associated with bisphosphonate and other antiresorptive agents (denosumab), and antiangiogenic agents (eg, bevacizumab, sunitinib) used for the treatment of osteoporosis or malignancy; risk of MRONJ is significantly higher in cancer patients receiving antiresorptive therapy compared to patients receiving osteoporosis treatment (regardless of medication used or dosing schedule). MRONJ risk is also increased with intravenous antiresorptive use compared to the minimal risk associated with oral bisphosphonate use, although risk appears to increase with oral bisphosphonates when duration of therapy exceeds 4 years (AAOMS [Ruggiero 2014]). The manufacturer's labeling states that in patients requiring invasive dental procedures, discontinuing bisphosphonates may reduce the risk of ONJ and clinical judgment should guide the decision. However, the AAOMS suggests there is currently no evidence that interrupting oral bisphosphonate therapy alters the risk of ONJ following tooth extraction, and that in patients receiving oral bisphosphonates for <4 years who have no clinical risk factors, no alternations or delay in any procedure common to oral/maxillofacial surgeons, periodontists, and other dental providers is necessary (special considerations apply to patients receiving dental implants). Conversely, in patients receiving oral bisphosphonates for >4 years or in patients receiving oral bisphosphonates for <4 years who have also taken corticosteroids or antiangiogenic medications concomitantly, the AAOMS recommends considering a 2-month, drug-free period prior to invasive dental procedures (recommendation based on a theoretical benefit). Patients developing ONJ during therapy should receive care by an oral surgeon (AAOMS [Ruggiero 2014]). According to the manufacturer, discontinuation of the bisphosphonate therapy should be considered (based on risk/benefit evaluation) in patients who develop ONJ.
• Renal impairment: Use with caution in patients with renal impairment (not recommended for use in patients with CrCl <35 mL/minute).
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Dosage form specific issues:
• Effervescent tablet: Each effervescent tablet contains 650 mg of sodium (NaCl 1650 mg). Use with caution in patients following a sodium-restricted diet.
Osteoporosis: Bone mineral density (BMD) should be evaluated 1 to 2 years after initiating therapy and every 1 to 2 years (or less frequently if stable) thereafter (AACE/ACE [Camacho 2016]; NOF [Cosman 2014]); 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 and 25(OH)D; may consider monitoring biochemical markers of bone turnover
Paget disease: 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 (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) (Singer 2014); pain; serum calcium and 25(OH)D
Pregnancy Risk Factor
Adverse events were observed in animal reproduction studies. It is not known if bisphosphonates cross the placenta, but fetal exposure is expected (Djokanovic 2008; Stathopoulos 2011). Bisphosphonates are incorporated into the bone matrix and gradually released over time. The amount available in the systemic circulation varies by dose and duration of therapy. Theoretically, there may be a risk of fetal harm when pregnancy follows the completion of therapy; however, available data have not shown that exposure to bisphosphonates during pregnancy significantly increases the risk of adverse fetal events (Djokanovic 2008; Levy 2009; Stathopoulos 2011). Until additional data is available, most sources recommend discontinuing bisphosphonate therapy in women of reproductive potential as early as possible prior to a planned pregnancy; use in premenopausal women should be reserved for special circumstances when rapid bone loss is occurring (Bhalla 2010; Pereira 2012; Stathopoulos 2011). Because hypocalcemia has been described following in utero bisphosphonate exposure, exposed infants should be monitored for hypocalcemia after birth (Djokanovic 2008; Stathopoulos 2011).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache, constipation, or diarrhea. Have patient report immediately to prescriber signs of low calcium (muscle cramps or spasms, numbness and tingling, or seizures); black, tarry, or bloody stools; angina; coughing up blood; severe abdominal pain; heartburn; difficulty swallowing; pain when swallowing; pharyngitis; severe nausea; severe vomiting; vomiting blood; severe bone pain; severe joint pain; severe muscle pain; groin, hip, or thigh pain; mouth sores; or jaw pain, or edema (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
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