Trials / Completed
CompletedNCT01796301
An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women
An Open-label, Randomized, Teriparatide-controlled Study to Evaluate the Effect of Treatment With Romosozumab in Postmenopausal Women With Osteoporosis Previously Treated With Bisphosphonate Therapy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 436 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Female
- Age
- 55 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Romozosumab | Administered by subcutaneous injection once a month. |
| DRUG | Teriparatide | Administered by subcutaneous injection once a day. |
Timeline
- Start date
- 2013-01-31
- Primary completion
- 2015-05-14
- Completion
- 2015-05-14
- First posted
- 2013-02-21
- Last updated
- 2022-11-29
- Results posted
- 2018-11-08
Locations
50 sites across 11 countries: United States, Argentina, Belgium, Canada, Colombia, Czechia, Denmark, Hungary, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01796301. Inclusion in this directory is not an endorsement.