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Placebo to Romosozumab
Romosozumab is a monoclonal antibody that inhibits sclerostin, a negative regulator of bone formation, thereby increasing bone mineral density and reducing fracture risk.
Romosozumab is a monoclonal antibody that inhibits sclerostin, a negative regulator of bone formation, thereby increasing bone mineral density and reducing fracture risk. Used for Postmenopausal osteoporosis in women at high risk of fracture, Osteoporosis in men at high risk of fracture.
At a glance
| Generic name | Placebo to Romosozumab |
|---|---|
| Sponsor | Amgen |
| Drug class | Sclerostin inhibitor monoclonal antibody |
| Target | Sclerostin (SOST protein) |
| Modality | Small molecule |
| Therapeutic area | Bone metabolism / Osteoporosis |
| Phase | Phase 3 |
Mechanism of action
Sclerostin is produced by osteocytes and suppresses the Wnt/β-catenin signaling pathway, which is essential for osteoblast activity and bone formation. By blocking sclerostin, romosozumab enhances osteoblast function and bone turnover, leading to rapid increases in bone mineral density. This mechanism is distinct from traditional antiresorptive agents and provides both bone formation and antiresorptive effects.
Approved indications
- Postmenopausal osteoporosis in women at high risk of fracture
- Osteoporosis in men at high risk of fracture
Common side effects
- Injection site reactions
- Arthralgia
- Headache
- Cardiovascular events (including myocardial infarction and stroke)
Key clinical trials
- Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea (PHASE3)
- Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes (PHASE2)
- Romosozumab Use to Build Skeletal Integrity (PHASE4)
- Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI (PHASE2)
- Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis (PHASE3)
- A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis (PHASE3)
- Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (PHASE3)
- A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785) (PHASE1)
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:
- Placebo to Romosozumab CI brief — competitive landscape report
- Placebo to Romosozumab updates RSS · CI watch RSS
- Amgen portfolio CI