Alendronate

Animal studies have indicated the following mode of action. At the cellular level, alendronate shows preferential localization to sites of bone resorption, specifically under osteoclasts.

• BINOSTO is a bisphosphonate indicated for: Treatment of osteoporosis in postmenopausal women ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Limitation of use: Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use ( 1.3 ) 1.1 Treatment of Osteoporosis in Postmenopausal Women BINOSTO effervescent tablet 70 mg is indicated for the treatment of osteoporosis in postmenopausal women.ICD-10: M81.0

• BINOSTO is contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see Warnings and Precautions (5.1) ] Inability to stand or sit upright for at least 30 minutes [see Dosage and Administration (2.3) ; Warnings and Precautions (5.1) ] Do not administer BINOSTO to patients at increased risk of aspiration Hypocalcemia [see Warnings and Precautions (5.2) ] Hypersensitivity to any component of this product. Hypersensitivity reactions including urticaria and angioedema have been reported [see Adverse Reactions (6.2) ] .contraindicated

70 mg BINOSTO effervescent tablet once weekly. ( 2.1 , 2.2 ) Instruct patients to: ( 2.3 ) Dissolve one tablet of BINOSTO in approximately half a glass of plain room temperature water (4 oz). Wait at least 5 minutes after the effervescence stops, stir the solution for approximately 10 seconds and consume contents. Swallow solution at least 30 minutes before the first food, beverage, or medication of the day. Avoid lying down for at least 30 minutes after taking BINOSTO and until after the first food of the day. 2.1 Treatment of Osteoporosis in Postmenopausal Women The recommended dosage is one 70 mg effervescent tablet once weekly. 2.2 Treatment to Increase Bone Mass in Men With Osteoporosis The recommended dosage is one 70 mg effervescent tablet once weekly. 2.3 Important Administration Instructions Instruct patients to do the following to assure adequate drug absorption and to decrease the risk of esophageal adverse reactions: Take BINOSTO upon arising for the day and at least 30 minutes before the first food, beverage, or medication of the day. Patients should not swallow the undissolved effervescent tablet, should not chew the effervescent tablet or allow the effervescent tablet to dissolve in their mouths because of the risk for oropharyngeal irritation [see Warnings and Precautions (5.1) ]. Dissolve the effervescent tablet in 4 ounces room temperature plain water only (not mineral water or flavored water). Wait at least 5 minutes after the effervescence stops and then stir the buffered solution for approximately 10 seconds and ingest.

Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue if new or worsening symptoms occur. ( 5.1 ) Hypocalcemia can worsen and must be corrected prior to use. ( 5.2 ) Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop. ( 5.3 ) Osteonecrosis of the Jaw has been reported. ( 5.4 ) Atypical Fractures Including Femoral Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture. Risk/benefit of continuing bisphosphonate therapy should be re-evaluated in these patients and interruption of bisphosphonate therapy should be considered. ( 5.5 ) Sodium Content: Each tablet contains 603 mg sodium, equivalent to 1532 mg NaCl. Use caution in patients on sodium restriction. ( 5.7 ) 5.1 Upper Gastrointestinal Adverse Reactions BINOSTO, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when BINOSTO is given to patients with active upper gastrointestinal problems (such as known Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, or ulcers). Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates including alendronate sodium.

The following clinically significant adverse drug reactions are described elsewhere in the labeling: Upper Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.1) ] Mineral Metabolism [see Warnings and Precautions (5.2) ] Musculoskeletal Pain [see Warnings and Precautions (5.3) ] Osteonecrosis of the Jaw [see Warnings and Precautions (5.4) ] Atypical Fractures Including Femoral Fractures [see Warnings and Precautions (5.5) ] Renal Impairment [see Warnings and Precautions (5.6) ] Patients sensitive to High Sodium Intake [see Warnings and Precautions (5.7) ] The most common adverse reactions (incidence greater than or equal to 3%) are abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Radius Health, Inc. at 1-855-672-3487 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of BINOSTO (alendronate sodium) effervescent tablet 70 mg is based on clinical trial data of alendronate sodium 10 mg daily and alendronate sodium 70 mg weekly.

Pregnancy: Discontinue when pregnancy is recognized. ( 8.1 ) BINOSTO is not indicated for use in pediatric patients. ( 8.4 ) BINOSTO is not recommended in patients with renal impairment (creatinine clearance less than 35 mL/min). ( 5.6 , 8.6 ) 8.1 Pregnancy Risk Summary Available data on the use of BINOSTO in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes. Discontinue BINOSTO when pregnancy is recognized. In animal reproduction studies, daily oral administration of alendronate to rats from before mating through the end of gestation or lactation showed decreased postimplantation survival and decreased pup body weight gain starting at doses equivalent to less than half of the highest recommended 40 mg clinical daily dose (based on body surface area, mg/m 2 ). Oral administration of alendronate to rats during organogenesis resulted in reduced fetal ossification starting at doses 3 times the 40 mg clinical daily dose. No similar fetal effects were observed in pregnant rabbits dosed orally during organogenesis at doses equivalent to approximately 10 times the 40 mg clinical daily dose. Delayed or failed delivery of offspring, protracted parturition, and late pregnancy maternal and fetal deaths due to maternal hypocalcemia occurred in rats at oral doses as low as one tenth the 40 mg clinical daily dose (See Data ).

Metabolism

Absorption Relative to an intravenous (IV) reference dose, the mean oral bioavailability of alendronate in women was 0.64% for doses ranging from 5 to 70 mg when administered after an overnight fast and two hours before a standardized breakfast. Oral bioavailability of the 10 mg tablet in men (0.59%) was similar to that in women when administered after an overnight fast and 2 hours before breakfast.

Significant lethality after single oral doses was seen in female rats and mice at 552 mg/kg (3256 mg/m 2 ) and 966 mg/kg (2898 mg/m 2 ), respectively. In males, these values were slightly higher, 626 and 1280 mg/kg, respectively. There was no lethality in dogs at oral doses up to 200 mg/kg (4000 mg/m 2 ). No specific information is available on the treatment of overdosage with BINOSTO. Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage. Milk or antacids should be given to bind alendronate. Due to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright. Dialysis would not be beneficial.

• Sep 29, 1995NDANDA020560Organon
• Apr 7, 2005NDANDA021762Organon Llc
• Feb 6, 2008ANDAANDA075710Impax Labs Inc
• Aug 4, 2008ANDAANDA090124Aurobindo Pharma
• Aug 4, 2008ANDAANDA076768Cipla
• Sep 24, 2009ANDAANDA090258Hangzhou Binjiang
• Mar 12, 2012NDANDA202344Radius
• Feb 25, 2013ANDAANDA090520Hikma

1. 1Pain13,74114%
2. 2Fatigue13,00013%
3. 3Drug Ineffective12,53013%
4. 4Femur Fracture11,43711%
5. 5Arthralgia11,23311%
6. 6Rheumatoid Arthritis10,09310%
7. 7Alopecia10,02210%
8. 8Abdominal Discomfort9,9459.9%
9. 9Systemic Lupus Erythematosus9,1239.1%
10. 10Rash8,9118.9%
11. 11Pemphigus8,8208.8%
12. 12Fall8,2878.3%
13. 13Glossodynia8,2178.2%
14. 14Arthropathy8,1808.2%
15. 15Swelling7,7267.7%

Recent PubMed references pinned to Alendronate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• The Early Effect of Alendronate, Hop Extract and Their Combination on Bone Structural Properties in a Rat Model of Osteoporosis.
  Medical sciences (Basel, Switzerland) · 2026 · Rođak E, Grgac R, Kostanjšek R, et al.
  PMID 42201031DOI 10.3390/medsci14020239
• Efficacy and safety of denosumab, zoledronic acid and alendronate on bone mineral density and trabecular bone score in men with osteoporosis.
  Age and ageing · 2026 · Zhou B, Zhang Y, Yu W, et al.
  PMID 42096654DOI 10.1093/ageing/afag121
• Bone fragility persists in long-term bisphosphonate-treated oim mice despite sex-specific changes in bone quality.
  Acta biomaterialia · 2026 · Muñoz A, Silvan A, Carriero A, et al.
  PMID 42061485DOI 10.1016/j.actbio.2026.04.054
• Effect of alendronate on survival and bone properties in Nothobranchius furzeri: insights from a model of accelerated aging.
  Experimental gerontology · 2026 · Butylina M, Kothmayer M, Basílio J, et al.
  PMID 42009084DOI 10.1016/j.exger.2026.113137
• Bond strength and interfacial stability of a universal adhesive to alendronate-treated dentin.
  Scientific reports · 2026 · Salem HS, Enan ET, Hamama H, et al.
  PMID 41876739DOI 10.1038/s41598-026-41664-3
• Bisphosphonate and statin: adverse effects of co-medication on wound healing in in vitro models of periodontal tissues.
  Acta odontologica Scandinavica · 2026 · Småland-Reksten A, Agger AE, Lian AM, et al.
  PMID 41852036DOI 10.2340/aos.v85.45585
• Abaloparatide increases bone mass by increasing bone formation regardless of alendronate pretreatment in mice.
  Journal of oral biosciences · 2026 · Makino A, Hasegawa T, Yamamoto T, et al.
  PMID 41714054DOI 10.1016/j.job.2025.100708
• Comparison of the Efficacy of Denosumab and Alendronate in Improving Bone Mineral Density in Osteoporosis Patients and High-Risk Populations: A Systematic Review and Meta-Analysis.
  Clinical drug investigation · 2026 · Zhu K, Li H, Zhang H, et al.
  PMID 41604138DOI 10.1007/s40261-025-01521-z

The 10 most recently updated of 212 ClinicalTrials.gov registrations naming Alendronate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Small Trial of Alendronate Impact on the Reservoir of HIV
  Not yet recruiting · Phase 2 · Interventional · 30 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT07216794updated 2026-06-10
• Bone, Exercise, Alendronate, and Caloric Restriction
  Recruiting · Phase 4 · Interventional · 900 enrolled · Wake Forest University Health Sciences
  NCT05764733updated 2026-06-09
• Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes
  Withdrawn · Phase 2 · Interventional · 0 enrolled · University of Pittsburgh
  NCT06973109updated 2026-06-04
• Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover
  Active not recruiting · Phase 4 · Interventional · 60 enrolled · Madhumathi Rao
  NCT05151484updated 2026-05-14
• Denosumab (DMAB) Discontinuation And Switching In Glucocorticoid-Induced Osteoporosis (GIOP): A Pilot Study
  Completed · Phase 4 · Interventional · 45 enrolled · University of Alabama at Birmingham
  NCT04177940updated 2026-04-23
• Alendronate for Osteonecrosis in Adults With Sickle Cell Disease
  Recruiting · Phase 2 · Interventional · 30 enrolled · University of California, Davis
  NCT06016634updated 2026-04-13
• Efficacy of Alendronate Versus Placebo in the Treatment of HIV-associated Osteoporosis (ANRS120)
  Completed · Phase 3 · Interventional · 140 enrolled · French National Agency for Research on AIDS and Viral Hepatitis
  NCT00120757updated 2026-04-03
• Precision Medicine Approach for Osteoporosis - Follow Up Study
  Enrolling by invitation · Phase 4 · Interventional · 40 enrolled · Paul F Netzel
  NCT06264609updated 2026-04-01
• A Phase II Trial of RAB001 (LLP2A-Alendronate) for Steroid-Induced Early-Stage Osteonecrosis of the Femoral Head
  Active not recruiting · Phase 2 · Interventional · 161 enrolled · ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.
  NCT07471880updated 2026-03-24
• Prospective, Randomized, Multicenter Clinical Trial of Bisphosphonates Combined With Vancomycin for the Treatment of Cierny-Mader Type I and III Osteomyelitis
  Not yet recruiting · Phase 3 · Interventional · 280 enrolled · Second Affiliated Hospital, School of Medicine, Zhejiang University
  NCT07435051updated 2026-02-27

CPIC-curated drug–gene pairs for Alendronate. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• FDPSCPIC D (provisional)

Frequently asked questions

How does Alendronate work?

Animal studies have indicated the following mode of action. At the cellular level, alendronate shows preferential localization to sites of bone resorption, specifically under osteoclasts.

What is Alendronate used for?

According to FDA labeling, Alendronate carries indications including: BINOSTO is a bisphosphonate indicated for: Treatment of osteoporosis in postmenopausal women ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Limitation of use: Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use ( 1.3 ) 1.1 Treatment of Osteoporosis in Postmenopausal Women BINOSTO effervescent tablet 70 mg is indicated for the treatment of osteoporosis in postmenopausal women.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Alendronate?

Alendronate is classified as Bone Surface Interactions, Bone Resorption Inhibition.

What are the brand names for Alendronate?

Alendronate is marketed under brand names including Binosto, Fosamax, Fosamax Plus D.

What are the contraindications for Alendronate?

Alendronate labeling lists contraindications including: BINOSTO is contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see Warnings and Precautions (5.1) ] Inability to stand or sit upright for at least 30 minutes [see Dosage and Administration (2.3) ; Warnings and Precautions (5.1) ] Do not administer BINOSTO to patients at increased risk of aspiration Hypocalcemia [see Warnings and Precautions (5.2) ] Hypersensitivity to any component of this product. Hypersensitivity reactions including urticaria and angioedema have been reported [see Adverse Reactions (6.2) ] .. Always consult the full prescribing information and a clinician.