Trials / Completed
CompletedNCT01732770
Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis
A Randomized Double-blind Study to Evaluate the Safety and Efficacy of Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 643 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Female
- Age
- 55 Years
- Healthy volunteers
- Not accepted
Summary
This study will compare the effectiveness of denosumab treatment every 6 months with once yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Denosumab | Denosumab 60 mg administered by subcutaneous injection once every 6 months. |
| DRUG | Zoledronic Acid | Zoledronic acid 5 mg administered by intravenous infusion once a year |
| DRUG | Placebo to Denosumab | Administered by subcutaneous injection once every 6 months |
| DRUG | Placebo to Zoledronic Acid | Administered by intravenous infusion once a year |
Timeline
- Start date
- 2012-11-07
- Primary completion
- 2015-01-07
- Completion
- 2015-01-07
- First posted
- 2012-11-26
- Last updated
- 2020-03-10
- Results posted
- 2016-01-25
Locations
45 sites across 7 countries: United States, Australia, Belgium, Canada, Denmark, Poland, Spain
Source: ClinicalTrials.gov record NCT01732770. Inclusion in this directory is not an endorsement.