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

NCT00515463

Phase 3 Completed 311 enrolled Amgen
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

EvaluationDrugModalityDoseRoute
Subject Denosumab Monoclonal antibody 60 mg Subcutaneous