Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
Public ClinicalTrials.gov record NCT01631214. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.
Study identification
- NCT ID
- NCT01631214
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 4,093 participants
Conditions and interventions
Conditions
Interventions
- Romosozumab Biological
- Alendronate Drug
- Placebo to Romosozumab Drug
- Placebo to Alendronate Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 55 Years to 90 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 4, 2012 (Actual)
- Primary completion
- Feb 27, 2017 (Actual)
- Completion
- Jun 29, 2017 (Actual)
- Last update posted
- Feb 21, 2025
2012 – 2017
United States locations
- U.S. sites
- 32
- U.S. states
- 20
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35294 | — |
| Research Site | Peoria | Arizona | 85381 | — |
| Research Site | Phoenix | Arizona | 85037 | — |
| Research Site | Scottsdale | Arizona | 85258 | — |
| Research Site | Downey | California | 90242 | — |
| Research Site | Greenbrae | California | 94904 | — |
| Research Site | Los Angeles | California | 90057 | — |
| Research Site | South Lake Tahoe | California | 96150 | — |
| Research Site | Tustin | California | 92780 | — |
| Research Site | Walnut Creek | California | 94598 | — |
| Research Site | Lakewood | Colorado | 80227 | — |
| Research Site | Fort Lauderdale | Florida | 33309 | — |
| Research Site | Miami | Florida | 33136 | — |
| Research Site | Stuart | Florida | 34996 | — |
| Research Site | West Palm Beach | Florida | 33409 | — |
| Research Site | Gainesville | Georgia | 30501 | — |
| Research Site | Maywood | Illinois | 60153 | — |
| Research Site | Quincy | Illinois | 62301 | — |
| Research Site | Indianapolis | Indiana | 46202 | — |
| Research Site | Bethesda | Maryland | 20817 | — |
| Research Site | Boston | Massachusetts | 02114 | — |
| Research Site | Detroit | Michigan | 48236 | — |
| Research Site | St Louis | Missouri | 63110 | — |
| Research Site | Las Vegas | Nevada | 89148 | — |
| Research Site | Las Cruces | New Mexico | 88011 | — |
| Research Site | Great Neck | New York | 11021 | — |
| Research Site | Bismarck | North Dakota | 58503 | — |
| Research Site | Pittsburgh | Pennsylvania | 15213 | — |
| Research Site | Wyomissing | Pennsylvania | 19610 | — |
| Research Site | Richmond | Virginia | 23233 | — |
| Research Site | Port Angeles | Washington | 98362 | — |
| Research Site | Madison | Wisconsin | 53705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 284 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01631214, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 21, 2025 · Synced Nov 9, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01631214 live on ClinicalTrials.gov.