Clinical trial
Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of…
NCT01631214 · Amgen, Industry · Completed
Key facts
| NCT number | NCT01631214 |
|---|---|
| Title | Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis |
| Official title | A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis |
| Acronym | ARCH |
| Lead sponsor | Amgen, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Postmenopausal Women With Osteoporosis |
| Intervention type | Biological, Drug |
| Interventions | Romosozumab, Alendronate, Placebo to Romosozumab, Placebo to Alendronate |
| Enrollment | 4,093 |
| Start date | May 4, 2012 |
| Primary completion | Feb 27, 2017 |
| Completion | Jun 29, 2017 |
| First posted | Jun 29, 2012 |
| Last update posted | Feb 21, 2025 |
| Countries | Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Denmark, Dominican Republic and 30 more |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: