ALENDRONATE SODIUM · WATSON LABS INC
Alendronate sodium helps postmenopausal women and men with osteoporosis by increasing bone mass and reducing the risk of hip and spine fractures. It also treats bone loss in patients taking glucocorticoid medications and manages Paget’s disease of bone. This medication is used to strengthen the skeletal system and prevent bone-related complications in those at risk.
How ALENDRONATE SODIUM Works
This medication works by concentrating at sites where bone is being broken down and inhibiting the activity of osteoclasts, the cells responsible for bone resorption. By reducing the rate of bone turnover, it allows bone formation to exceed bone loss, which leads to a progressive increase in overall bone mass. Because the drug becomes inactive once it is incorporated into the bone matrix, continuous administration is necessary to maintain its effects on new bone surfaces.
Details
- Status
- Prescription
- First Approved
- 1995-09-29
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION
Companies
ALENDRONATE SODIUM Approval History
What ALENDRONATE SODIUM Treats
4 indicationsALENDRONATE SODIUM is approved for 4 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Postmenopausal osteoporosis
- Osteoporosis in men
- Glucocorticoid-induced osteoporosis
- Paget's disease of bone
ALENDRONATE SODIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ALENDRONATE SODIUM
3 of 14FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 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) |
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.
ALENDRONATE SODIUM FDA Label Details
Indications & Usage
Alendronate sodium 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 Alendronate sodium tablets, USP are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopa...
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BINOSTO
Full clinical data, patents, trials, and competitive landscape for alendronate sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.