Conditions: Bone Metastases
Keywords: Fractures Compressions Bisphosphonates Bone metastases Breast cancer Skeletal Radiation Surgery to Bone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2049
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Denosumab intervention 2: Zoledronic Acid
Intervention descriptions: intervention 1: Q4W 120 mg denosumab SC injection and 4 mg zoledronic acid (Zometa) placebo IV over a minimum of 15 minutes intervention 2: Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC

Protocol document: