Authors
Fred Saad, Donald M Gleason, Robin Murray, Simon Tchekmedyian, Peter Venner, Louis Lacombe, Joseph L Chin, Jeferson J Vinholes, J Allen Goas, Ming Zheng
Publication date
2004/6/2
Journal
Journal of the National Cancer Institute
Volume
96
Issue
11
Pages
879-882
Publisher
Oxford University Press
Description
In a placebo-controlled randomized clinical trial, zoledronic acid (4 mg via a 15-minute infusion every 3 weeks for 15 months) reduced the incidence of skeletal-related events (SREs) in men with hormone-refractory metastatic prostate cancer. Among 122 patients who completed a total of 24 months on study, fewer patients in the 4-mg zoledronic acid group than in the placebo group had at least one SRE (38% versus 49%, difference = –11.0%, 95% confidence interval [CI] = –20.2% to –1.3%; P = .028), and the annual incidence of SREs was 0.77 for the 4-mg zoledronic acid group versus 1.47 for the placebo group (P= .005). The median time to the first SRE was 488 days for the 4-mg zoledronic acid group versus 321 days for the placebo group (P = .009). Compared with placebo, 4 mg of zoledronic acid reduced the ongoing risk of SREs by 36% (risk ratio = 0.64, 95% CI = 0.485 to 0.845; P = .002). Patients in …
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