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Zoledronic acid and denosumab are potent inhibitors of osteoclast-mediated bone resorption. Both are FDA approved to treat men with bone metastases from prostate cancer and disease progression despite androgen-deprivation therapy (ADT). They are also widely used to treat men with castration-sensitive metastatic prostate cancer. Given the potential toxicity burden and economic impact of these agents, industry- and NCI-funded Alliance investigators conducted a multicenter phase III study of zoledronic acid in the setting of castration-sensitive metastatic disease.
Patients treated with continuous ADT for metastatic prostate cancer for <6 months were randomized to receive intravenous zoledronic acid (4.0 mg or adjusted renal doses) or placebo e…