Trials / Completed
CompletedNCT00515463
A Multi-Center, Randomized, Open-Label Study to Assess the Immunogenicity and Safety of Denosumab in Pre-filled Syringe Compared to Vial in Subjects With Low Bone Mineral Density
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 311 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the immunogenicity profiles of denosumab pre-filled syringe (PFS) and vial at 6 months in postmenopausal women with low bone mineral density (BMD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | denosumab | 60 mg denosumab in 1mL |
| BIOLOGICAL | denosumab | 60 mg denosumab in 1mL |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2008-03-01
- Completion
- 2009-03-01
- First posted
- 2007-08-13
- Last updated
- 2013-10-31
- Results posted
- 2013-10-31
Source: ClinicalTrials.gov record NCT00515463. Inclusion in this directory is not an endorsement.