FOSAMAX (alendronate sodium) · Merck
FOSAMAX is a bisphosphonate indicated for: Treatment and prevention of osteoporosis in postmenopausal women Treatment to increase bone mass in men with osteoporosis Treatment of glucocorticoid-induced osteoporosis Treatment of Paget's disease of bone Limitations 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.
Details
- Status
- Prescription
- First Approved
- 1995-09-29
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION
FOSAMAX Approval History
What FOSAMAX Treats
4 indicationsFOSAMAX is approved for 4 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Postmenopausal osteoporosis
- Osteoporosis in men
- Glucocorticoid-induced osteoporosis
- Paget's disease of bone
Same approved indications as ALENDRONATE SODIUM (same active ingredient).
Merck's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06016634 | 1693339 5K23HL148310, 2020095 | Ph 2 | recruiting | Alendronate for Osteonecrosis in Adults With Sickle Cell Disease |
| NCT05493761 OsteoNAFLD | 88235 | Ph 4 | active not recruiting | Effect of Anti-osteoporotic Medications on Nonalcoholic Fatty Liver Disease |
| NCT04704947 | osteoprosis | Ph 3 | recruiting | Clinical Study Evaluating Beta Blockers Use and Fracture Risk in Patients With Primary Osteoporosis |
| NCT02795546 | PMVIDS/PER/0029/2014 | Ph 4 | completed | Effect of Alendronate With β - TCP Bone Substitute in Surgical Therapy of Periodontal Intra-osseous Defects. |
| NCT00996801 results posted | 5442-012 2009-014729-18, CTRI/2010/091/000258 | Ph 2 | completed | MK-5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate (MK-5442-012) |
| NCT00822029 | 2006-005678-36 | Ph 3 | terminated | Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FOSAMAX FDA Label Details
Indications & Usage
FDA Label (PDF)FOSAMAX is a bisphosphonate indicated for: Treatment and prevention of osteoporosis in postmenopausal women Treatment to increase bone mass in men with osteoporosis Treatment of glucocorticoid-induced osteoporosis Treatment of Paget's disease of bone Limitations 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. 1.1 Treatment of Osteoporosis in Postmenopausal Women FOSAMAX ® is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, FOSAMAX increases bone...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.