Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma

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1,779 patients with solid tumours (except breast and prostate) or myeloma, as well as at least 1 bone metastasis or osteolytic lesion as confirmed by radiographic imaging were randomized to receive either monthly subcutaneous injections of denosumab or intravenous administration of zoledronic acid to compare the efficacy and safety of these two treatments. Results at 34 months indicated that denosumab was noninferior when compared to zoledronic acid, and both groups yielded similar overall survival rates, disease progression, and safety. The zoledronic acid group, however, experienced an increased frequency of acute phase reactions, while the denosumab group experienced an increased frequency of hypocalcemia.