A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
subject incidence of treatment-emergent adverse events, immunogenicity, and safety laboratory parameters
4 weeks after the last dose of open label treatment
Yes
MD
Study Director
Amgen
Australia: Therapeutic Goods Administration
20050147
NCT00286091
February 2006
February 2014
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