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FOSAMAX PLUS D
FOSAMAX PLUS D combines alendronate (a bisphosphonate that inhibits bone resorption) with cholecalciferol (vitamin D3) to prevent and treat osteoporosis while ensuring adequate vitamin D status.
FOSAMAX PLUS D combines alendronate (a bisphosphonate that inhibits bone resorption) with cholecalciferol (vitamin D3) to prevent and treat osteoporosis while ensuring adequate vitamin D status. Used for Osteoporosis prevention and treatment in postmenopausal women, Osteoporosis in men, Glucocorticoid-induced osteoporosis.
At a glance
| Generic name | FOSAMAX PLUS D |
|---|---|
| Sponsor | Organon and Co |
| Drug class | Bisphosphonate + vitamin D3 combination |
| Target | Osteoclast proton pump (alendronate); vitamin D receptor (cholecalciferol) |
| Modality | Small molecule |
| Therapeutic area | Bone metabolism / Osteoporosis |
| Phase | FDA-approved |
Mechanism of action
Alendronate works by binding to hydroxyapatite in bone and inhibiting osteoclast-mediated bone resorption, thereby increasing bone mineral density. Cholecalciferol supplementation ensures adequate vitamin D levels, which is essential for calcium absorption and bone health. Together, these components address both the primary pathology of osteoporosis and a common nutritional deficiency that impairs treatment efficacy.
Approved indications
- Osteoporosis prevention and treatment in postmenopausal women
- Osteoporosis in men
- Glucocorticoid-induced osteoporosis
Common side effects
- Gastrointestinal upset (nausea, dyspepsia, abdominal pain)
- Musculoskeletal pain
- Headache
- Esophageal irritation
- Atypical femoral fracture (rare)
Key clinical trials
- Prospective, Randomized, Multicenter Clinical Trial of Bisphosphonates Combined With Vancomycin for the Treatment of Cierny-Mader Type I and III Osteomyelitis (PHASE3)
- Bone Turnover Markers and Treatment Efficacy in Postmenopausal Osteoporosis (NA)
- Effect of Anti-osteoporotic Medications on Nonalcoholic Fatty Liver Disease (PHASE4)
- Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)
- Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover (PHASE4)
- Alendronate in an Weekly Effervescent Tablet Formulation Following Denosumab Discontinuation
- A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227) (PHASE3)
- A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- FOSAMAX PLUS D CI brief — competitive landscape report
- FOSAMAX PLUS D updates RSS · CI watch RSS
- Organon and Co portfolio CI