Conditions: Bone Metastases
Keywords: Bone metastases lytic bone lesions advanced cancer multiple myeloma lymphoma solid tumors skeletal related events skeletal fractures spinal cord compressions, radiation to bone surgery to bone, bisphosphonates denosumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1779
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 (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)

Detailed description:

Arms:
arm 1: denosumab placebo with active zoledronic acid arm 2: active denosumab with zoledronic acid placebo

Interventions: intervention 1: Denosumab intervention 2: Zoledronic Acid
Intervention descriptions: intervention 1: 120 milligrams by subcutaneous injection every 4 weeks intervention 2: 4 milligrams intravenous Zoledronic Acid over minimum 15 minutes every 4 weeks

Protocol document: