• Steven Boonen, Jean-Yves Reginster, Jean-Marc Kaufman, Kurt Lippuner, Jose Zanchetta, Bente Langdahl, Rene Rizzoli, Stanley Lipschitz, Hans Peter Dimai, Richard Witvrouw, Erik Eriksen, Kim Brixen, Luis Russo, Frank Claessens, Philemon Papanastasiou, Oscar Antunez, Guoqin Su, Christina Bucci-Rechtweg, Josef Hruska, Elodie Incera, Dirk Vanderschueren, and Eric Orwoll.
• Katholieke Universiteit Leuven, Leuven, Belgium. en.boonen@uz.kuleuven.ac.be
• N. Engl. J. Med.. 2012 Nov 1;367(18):1714-23.

BackgroundFractures in men are a major health issue, and data on the antifracture efficacy of therapies for osteoporosis in men are limited. We studied the effect of zoledronic acid on fracture risk among men with osteoporosis.MethodsIn this multicenter, double-blind, placebo-controlled trial, we randomly assigned 1199 men with primary or hypogonadism-associated osteoporosis who were 50 to 85 years of age to receive an intravenous infusion of zoledronic acid (5 mg) or placebo at baseline and at 12 months. Participants received daily calcium and vitamin D supplementation. The primary end point was the proportion of participants with one or more new morphometric vertebral fractures over a period of 24 months.ResultsThe rate of any new morphometric vertebral fracture was 1.6% in the zoledronic acid group and 4.9% in the placebo group over the 24-month period, representing a 67% risk reduction with zoledronic acid (relative risk, 0.33; 95% confidence interval, 0.16 to 0.70; P=0.002). As compared with men who received placebo, men who received zoledronic acid had fewer moderate-to-severe vertebral fractures (P=0.03) and less height loss (P=0.002). Fewer participants who received zoledronic acid had clinical vertebral or nonvertebral fractures, although this difference did not reach significance because of the small number of fractures. Bone mineral density was higher and bone-turnover markers were lower in the men who received zoledronic acid (P<0.05 for both comparisons). Results were similar in men with low serum levels of total testosterone. The zoledronic acid and placebo groups did not differ significantly with respect to the incidence of death (2.6% and 2.9%, respectively) or serious adverse events (25.3% and 25.2%).ConclusionsZoledronic acid treatment was associated with a significantly reduced risk of vertebral fracture among men with osteoporosis. (Funded by Novartis Pharma; ClinicalTrials.gov number, NCT00439647.).

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