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

Steven Boonen, Eric Orwoll, Jay Magaziner, Cathleen S. Colõn-Emeric, Jonathan D. Adachi, Christina Bucci-Rechtweg, Patrick Haentjens, Jean Marc Kaufman, Rene Rizzoli, Dirk Vanderschueren, Frank Claessens, An Sermon, Richard Witvrouw, Koen Milisen, Guoqin Su, Kenneth W. Lyles

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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.

Original languageEnglish (US)
Pages (from-to)2084-2090
Number of pages7
JournalJournal of the American Geriatrics Society
Volume59
Issue number11
DOIs
StatePublished - Nov 2011

Fingerprint

zoledronic acid
Hip Fractures
Bone Density
Placebos
Femur Neck
Vitamin D
Pelvic Bones
Wounds and Injuries

Keywords

  • bone mineral density
  • hip fracture
  • men
  • once-yearly
  • osteoporosis

ASJC Scopus subject areas

  • Geriatrics and Gerontology

Cite this

Boonen, S., Orwoll, E., Magaziner, J., Colõn-Emeric, C. S., Adachi, J. D., Bucci-Rechtweg, C., ... Lyles, K. W. (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. https://doi.org/10.1111/j.1532-5415.2011.03666.x

Once-yearly zoledronic acid in older men compared with women with recent hip fracture. / Boonen, Steven; Orwoll, Eric; Magaziner, Jay; Colõn-Emeric, Cathleen S.; Adachi, Jonathan D.; Bucci-Rechtweg, Christina; Haentjens, Patrick; Kaufman, Jean Marc; Rizzoli, Rene; Vanderschueren, Dirk; Claessens, Frank; Sermon, An; Witvrouw, Richard; Milisen, Koen; Su, Guoqin; Lyles, Kenneth W.

In: Journal of the American Geriatrics Society, Vol. 59, No. 11, 11.2011, p. 2084-2090.

Research output: Contribution to journalArticle

Boonen, S, Orwoll, E, Magaziner, J, Colõn-Emeric, CS, Adachi, JD, Bucci-Rechtweg, C, Haentjens, P, Kaufman, JM, Rizzoli, R, Vanderschueren, D, Claessens, F, Sermon, A, Witvrouw, R, Milisen, K, Su, G & Lyles, KW 2011, 'Once-yearly zoledronic acid in older men compared with women with recent hip fracture', Journal of the American Geriatrics Society, vol. 59, no. 11, pp. 2084-2090. https://doi.org/10.1111/j.1532-5415.2011.03666.x
Boonen, Steven ; Orwoll, Eric ; Magaziner, Jay ; Colõn-Emeric, Cathleen S. ; Adachi, Jonathan D. ; Bucci-Rechtweg, Christina ; Haentjens, Patrick ; Kaufman, Jean Marc ; Rizzoli, Rene ; Vanderschueren, Dirk ; Claessens, Frank ; Sermon, An ; Witvrouw, Richard ; Milisen, Koen ; Su, Guoqin ; Lyles, Kenneth W. / Once-yearly zoledronic acid in older men compared with women with recent hip fracture. In: Journal of the American Geriatrics Society. 2011 ; Vol. 59, No. 11. pp. 2084-2090.
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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.",
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AU - Adachi, Jonathan D.

AU - Bucci-Rechtweg, Christina

AU - Haentjens, Patrick

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