drugset / Trial / NCT00515463
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
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2007-05
- Primary completion
- 2008-03
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |