Journal
JOURNAL OF THE AMERICAN GERIATRICS SOCIETY
Volume 59, Issue 11, Pages 2084-2090Publisher
WILEY-BLACKWELL
DOI: 10.1111/j.1532-5415.2011.03666.x
Keywords
bone mineral density; hip fracture; men; once-yearly; osteoporosis
Categories
Funding
- Novartis Pharma AG, Basel, Switzerland
- Novartis
- Merck
- Eli Lilly
- National Institute on Aging (NIA) Claude D. Pepper Older Americans Independence Center [P30-AG028747, R37 AG009901, R01 AG029315, R01 AG018668]
- Pfizer
- Amgen
- AstraZeneca
- Nycomed
- Procter Gamble
- Roche
- Sanofi-Aventis
- Servier
- Wyeth
- Bristol-Myers Squibb
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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. J Am Geriatr Soc 59:2084-2090, 2011.
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