Trials / Completed
CompletedNCT00523341
Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 4,550 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Female
- Age
- 60 Years – 94 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective was to describe the safety and tolerability of up to 10 years or 7 years denosumab administration as measured by adverse event monitoring, immunogenicity and safety laboratory parameters in participants who previously received denosumab or placebo, respectively.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Denosumab | Administered by subcutaneous injection once every 6 months. |
Timeline
- Start date
- 2007-08-07
- Primary completion
- 2015-07-19
- Completion
- 2015-07-19
- First posted
- 2007-08-31
- Last updated
- 2022-11-07
- Results posted
- 2016-07-12
Source: ClinicalTrials.gov record NCT00523341. Inclusion in this directory is not an endorsement.