Once-yearly zoledronic acid in older men compared with women with recent hip fracture.

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Boonen, S; Orwoll, E; Magaziner, J; Colón-Emeric, CS; Adachi, JD; Bucci-Rechtweg, C; Haentjens, P; Kaufman, J-M; Rizzoli, R; Vanderschueren, D; Claessens, F; Sermon, A; Witvrouw, R; Milisen, K; Su, G; Lyles, KW; HORIZON Recurrent Fracture Trial,

Published Date

  • November 2011

Published In

Volume / Issue

  • 59 / 11

Start / End Page

  • 2084 - 2090

PubMed ID

  • 22091563

Pubmed Central ID

  • 22091563

Electronic International Standard Serial Number (EISSN)

  • 1532-5415

International Standard Serial Number (ISSN)

  • 0002-8614

Digital Object Identifier (DOI)

  • 10.1111/j.1532-5415.2011.03666.x

Language

  • eng