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Efficacy analyses are vs. the most potent bisphosphonate used in clinical practice, and the only one approved for use in prostate cancer bone metastasis. This is NOT a comparison vs. placebo, as has been done in Novartis registration trial The primary endpoint is represented on a Kaplan Meier curve. Denosumab was superior to zoledronic acid and reduced the risk of a first on-study SRE by 18% with a confidence interval from 0.71 to 0.95. The P value was equal to 0.0002 for noninferiority and equal to 0.008 for superiority. The median time to first on-study SRE was 20.7 months for denosumab and was 17.1 months for zoledronic acid, a 3.6 mo difference . The 2 most common components of SREs were fractures and radiation to bone. 727 subjects experienced a first on-study SRE; subject incidence was 341 (35.9%) in the denosumab arm and 386 (40.6%) in the zoledronic acid arm.