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

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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.
Keywords
men, once-yearly, hip fracture, bone mineral density, osteoporosis, BONE-MINERAL DENSITY, EXCESS MORTALITY, DOUBLE-BLIND, OSTEOPOROTIC FRACTURE, MULTICENTER, SURVIVAL, RISK, METAANALYSIS, RISEDRONATE, ALENDRONATE

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Chicago
Boonen, Steven, Eric Orwoll, Jay Magaziner, Cathleen S Colón-Emeric, Jonathan D Adachi, Christina Bucci-Rechtweg, Patrick Haentjens, et al. 2011. “Once-yearly Zoledronic Acid in Older Men Compared with Women with Recent Hip Fracture.” Journal of the American Geriatrics Society 59 (11): 2084–2090.
APA
Boonen, Steven, Orwoll, E., Magaziner, J., Colón-Emeric, C. S., Adachi, J. D., Bucci-Rechtweg, C., Haentjens, P., et al. (2011). Once-yearly zoledronic acid in older men compared with women with recent hip fracture. JOURNAL OF THE AMERICAN GERIATRICS SOCIETY, 59(11), 2084–2090.
Vancouver
1.
Boonen S, Orwoll E, Magaziner J, Colón-Emeric CS, Adachi JD, Bucci-Rechtweg C, et al. Once-yearly zoledronic acid in older men compared with women with recent hip fracture. JOURNAL OF THE AMERICAN GERIATRICS SOCIETY. 2011;59(11):2084–90.
MLA
Boonen, Steven, Eric Orwoll, Jay Magaziner, et al. “Once-yearly Zoledronic Acid in Older Men Compared with Women with Recent Hip Fracture.” JOURNAL OF THE AMERICAN GERIATRICS SOCIETY 59.11 (2011): 2084–2090. Print.
@article{2139182,
  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.},
  author       = {Boonen, Steven and Orwoll, Eric and Magaziner, Jay and Col{\'o}n-Emeric, Cathleen S and Adachi, Jonathan D and Bucci-Rechtweg, Christina and Haentjens, Patrick and Kaufman, Jean and Rizzoli, Rene and Vanderschueren, Dirk and Claessens, Frank and Sermon, An and Witvrouw, Richard and Milisen, Koen and Su, Guoqin and Lyles, Kenneth W},
  issn         = {0002-8614},
  journal      = {JOURNAL OF THE AMERICAN GERIATRICS SOCIETY},
  keyword      = {men,once-yearly,hip fracture,bone mineral density,osteoporosis,BONE-MINERAL DENSITY,EXCESS MORTALITY,DOUBLE-BLIND,OSTEOPOROTIC FRACTURE,MULTICENTER,SURVIVAL,RISK,METAANALYSIS,RISEDRONATE,ALENDRONATE},
  language     = {eng},
  number       = {11},
  pages        = {2084--2090},
  title        = {Once-yearly zoledronic acid in older men compared with women with recent hip fracture},
  url          = {http://dx.doi.org/10.1111/j.1532-5415.2011.03666.x},
  volume       = {59},
  year         = {2011},
}

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