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FOSAMAX PLUS
FOSAMAX PLUS combines alendronate (a bisphosphonate) with cholecalciferol (vitamin D3) to inhibit bone resorption and improve calcium absorption.
FOSAMAX PLUS combines alendronate (a bisphosphonate) with cholecalciferol (vitamin D3) to inhibit bone resorption and improve calcium absorption. Used for Osteoporosis in postmenopausal women, Osteoporosis in men, Glucocorticoid-induced osteoporosis.
At a glance
| Generic name | FOSAMAX PLUS |
|---|---|
| Sponsor | Organon and Co |
| Drug class | Bisphosphonate with vitamin D3 supplement |
| Target | Osteoclast farnesyl pyrophosphate synthase (alendronate); vitamin D receptor (cholecalciferol) |
| Modality | Small molecule |
| Therapeutic area | Bone health / Osteoporosis |
| Phase | FDA-approved |
Mechanism of action
Alendronate works by binding to hydroxyapatite in bone and inhibiting osteoclast-mediated bone resorption, slowing bone loss. Cholecalciferol supplementation enhances intestinal calcium absorption and supports bone mineralization. Together, these components reduce fracture risk in osteoporosis by maintaining or increasing bone mineral density.
Approved indications
- Osteoporosis in postmenopausal women
- Osteoporosis in men
- Glucocorticoid-induced osteoporosis
Common side effects
- Gastrointestinal upset (nausea, dyspepsia, abdominal pain)
- Musculoskeletal pain
- Headache
- Esophageal irritation
- Hypocalcemia
Key clinical trials
- A Phase II Trial of RAB001 (LLP2A-Alendronate) for Steroid-Induced Early-Stage Osteonecrosis of the Femoral Head (PHASE2)
- Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes (PHASE2)
- Prospective, Randomized, Multicenter Clinical Trial of Bisphosphonates Combined With Vancomycin for the Treatment of Cierny-Mader Type I and III Osteomyelitis (PHASE3)
- Alendronate for Osteonecrosis in Adults With Sickle Cell Disease (PHASE2)
- Bone, Exercise, Alendronate, and Caloric Restriction (PHASE4)
- Alendronate to Reduce Pelvic Insufficiency Fractures in Cervical Cancer Patients Undergoing Chemoradiation (PHASE1, PHASE2)
- Bone Turnover Markers and Treatment Efficacy in Postmenopausal Osteoporosis (NA)
- Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study (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 |