FOSAMAX PLUS D (alendronate sodium)
Fosamax Plus D is a combination medication that treats osteoporosis in postmenopausal women and helps increase bone mass in men with the same condition. It is used to strengthen bones and reduce the risk of fractures, specifically those occurring in the hip and spine. While the medication contains a vitamin component, it should not be used as a standalone therapy for vitamin D deficiency. Because the optimal duration of use is not yet determined, healthcare providers typically re-evaluate the need for continued therapy periodically, especially for patients at low risk for fractures.
How FOSAMAX PLUS D Works
The alendronate component of this medication targets sites of bone resorption and inhibits the activity of osteoclasts, the cells responsible for breaking down bone. By slowing this process, bone formation is able to exceed resorption, which leads to progressive gains in bone mass. Additionally, the vitamin D3 component is converted into an active hormone that helps the body absorb calcium through the intestines.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2005-04-07
- Routes
- ORAL
- Dosage Forms
- TABLET
FOSAMAX PLUS D Approval History
What FOSAMAX PLUS D Treats
2 indicationsFOSAMAX PLUS D is approved for 2 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Osteoporosis
- Vitamin D Deficiency
FOSAMAX PLUS D 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.
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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.
FOSAMAX PLUS D FDA Label Details
Indications & Usage
FDA Label (PDF)FOSAMAX PLUS D is indicated for the treatment of Osteoporosis; Vitamin D Deficiency.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment