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

J Am Geriatr Soc. 2011 Nov;59(11):2084-90. doi: 10.1111/j.1532-5415.2011.03666.x. Epub 2011 Oct 21.

Abstract

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Absorptiometry, Photon
  • Aged
  • Bone Density / drug effects
  • Bone Density Conservation Agents / administration & dosage*
  • Diphosphonates / administration & dosage*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Hip Fractures / epidemiology
  • Hip Fractures / prevention & control*
  • Humans
  • Imidazoles / administration & dosage*
  • Incidence
  • Injections, Intravenous
  • Male
  • Osteoporosis / diagnosis
  • Osteoporosis / drug therapy*
  • Osteoporosis / epidemiology
  • Prevalence
  • Time Factors
  • Treatment Outcome
  • Zoledronic Acid

Substances

  • Bone Density Conservation Agents
  • Diphosphonates
  • Imidazoles
  • Zoledronic Acid