Once-Yearly Zoledronic Acid in Older Men Compared with Women with Recent Hip Fracture

Objectives To assess the efficacy of once‐yearly zoledronic acid (ZOL) 5 mg in increasing bone mineral density (BMD) in men with a recent hip fracture participating in the Health Outcomes and Reduced Incidence with Zoledronic Acid Once‐ Yearly Recurrent Fracture Trial and to compare the efficacy with that in women from the same study. Design Randomized, placebo‐controlled, double‐blind trial. Setting International multicenter. Participants Five hundred and eight men and 1,619 women within 90 days of surgical repair of low‐trauma hip fracture in the same study (for comparison). Intervention Once‐yearly intravenous (IV) ZOL 5 mg (n = 248) or placebo (n = 260), loading dose of vitamin D, daily calcium, and vitamin D supplements. Measurement Changes in BMD. Results Percentage change from baseline in total hip BMD at Months 12 and 24 was significantly higher with ZOL than with placebo (between‐group difference, 2.0%, P = .003, and 3.8%, P = .002, respectively). Percentage change from baseline in femoral neck BMD at Month 24 was significantly higher with ZOL than with placebo (3.8%, P = .003). The BMD benefit was comparable with that observed in women in this study. New clinical fractures occurred in 36 (7.1%) participants (ZOL, n = 16; placebo, n = 20; P = .64). The ZOL safety profile was comparable with that of placebo, with no significant differences in cardiovascular or long‐term renal function and a trend toward lower mortality in ZOL‐treated men. Conclusion Once‐yearly IV ZOL 5 mg increases bone mass at the hip and femoral neck in men within 90 days of repair of a low‐trauma hip fracture. Increases were of a similar magnitude to those observed in women in the same study.