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NCT01796301 · ClinicalTrials.gov registry record · Phase 3
An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women
A Phase 3 study of Postmenopausal Osteoporosis, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 436
- Enrollment target
- 20
- Study locations
NCT01796301: Completed Phase 3 study of Postmenopausal Osteoporosis, sponsored by Amgen.
NCT01796301 is a Phase 3 study of Postmenopausal Osteoporosis that has completed, run by Amgen. The registered enrollment target is 436 participants, below the 490-participant average among 14 other Postmenopausal Osteoporosis trials with a reported enrollment target (11% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01796301, a Phase 3 study of Postmenopausal Osteoporosis, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 436 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.
Primary Outcome
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). Percent change from baseline through month 12 is the average of the treatment effect at months 6 and 12.
Conditions Studied
Interventions
- DRUG Teriparatide
- DRUG Romozosumab
Study Locations (20)
Other
- Research Site - Genk
- Research Site - Ghent
- Research Site - Leuven
- Research Site - Liège
- Research Site - Brno
Massachusetts
- Research Site - Boston
- Research Site - Boston
Buenos Aires
- Research Site - Ciudad Autonoma de Buenos Aires
- Research Site - Ciudad Autonoma de Buenos Aires
Ontario
- Research Site - Toronto
- Research Site - Toronto
Georgia
- Research Site - Gainesville
Maryland
- Research Site - Bethesda
Michigan
- Research Site - Detroit
Córdoba Province
- Research Site - Córdoba
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 436 participants |
| Start Date | 2013-01-31 |
| Est. Completion | 2015-05-14 |
| Phase | Phase 3 |
What the finished NCT01796301 record still lists
NCT01796301 is an interventional study that assigns participants to a tested intervention. The registered 436 participants enrollment target is mid-sized for trials with a published cap, below the 490-participant average among 14 other Postmenopausal Osteoporosis trials with a reported enrollment target (11% lower).
The record links to 1 condition, with Postmenopausal Osteoporosis appearing as the primary indexed condition, and to 2 interventions - of which Teriparatide is the first listed.
NCT01796301 names 20 study sites across 13 states, led by Other, Massachusetts, Buenos Aires.
Frequently Asked Questions
What is clinical trial NCT01796301 about?
NCT01796301 is a clinical study titled "An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women". The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.
What is the current status of trial NCT01796301?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 436 participants. The study started on 2013-01-31. Estimated completion is 2015-05-14.
What conditions does trial NCT01796301 study?
This clinical trial studies the following conditions: Postmenopausal Osteoporosis.
What interventions are being tested in trial NCT01796301?
The interventions under investigation include: Teriparatide (DRUG), Romozosumab (DRUG).
Who is sponsoring clinical trial NCT01796301?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01796301 being conducted?
This trial has 20 study locations across Georgia, Maryland, Massachusetts, Michigan, Buenos Aires. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Postmenopausal Osteoporosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01796301's enrollment target sits among peer trials
436 7th of 14 higher than 8 of 14 other Postmenopausal Osteoporosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postmenopausal Osteoporosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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