Trials / Completed
CompletedNCT02791516
A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis
A Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Postmenopausal South Korean Women With Osteoporosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Female
- Age
- 55 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy X-ray absorptiometry (DXA) in postmenopausal women with osteoporosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Romosozumab | Administered by subcutaneous injection once a month (QM) |
| DRUG | Placebo | Administered by subcutaneous injections once a month |
Timeline
- Start date
- 2017-01-16
- Primary completion
- 2018-02-12
- Completion
- 2018-12-21
- First posted
- 2016-06-06
- Last updated
- 2019-10-07
- Results posted
- 2019-07-05
Locations
10 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02791516. Inclusion in this directory is not an endorsement.