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Type(s) of Cancer Bladder,Colorectal,Esophageal,Gastric,Head-Neck,Kidney,Lung (Non-Small Cell),Lung (Small Cell),Lymphoma (Non-Hodgkins),Melanoma,Multiple Myeloma,Neuroendocrine Tumors,Ovarian,Pancreatic,Soft Tissue Sarcoma,Uterine Cervix
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects With Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma.
Provider Data DescriptionThe primary objective of this study was to determine if denosumab is noninferior to zoledronic acid with respect to the first on-study SRE (pathologic fracture, radiation therapy to bone [including the use of radioisotopes], surgery to bone, or spinal cord compression) in subjects with advanced cancer and bone metastases (or lytic bone lesions from multiple myeloma). The secondary objectives were to determine if denosumab is superior to zoledronic acid with respect to first on-study SRE, to determine if denosumab is superior to zoledronic acid with respect to the first-and-subsequent on-study SRE (multiple event analysis), and to assess the safety and tolerability of denosumab compared with zoledronic acid.
Partial set or SubsetN/A
Patients in dataset1779
# of Patients Control702
# of Patients Experimental702
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe 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)