Conditions: Bone Metastases
Keywords: Bone metastases Hormone-refractory prostate cancer Skeletal Fractures Compressions Bisphosphonates
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1904
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: zoledronic acid intervention 2: denosumab
Intervention descriptions: intervention 1: Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC intervention 2: Q4W 120 mg denosumab SC and 4 mg zoledronic acid placebo IV over a minimum of 15 minutes

Protocol document: