Once-Yearly Zoledronic Acid in Older Men Compared with Women with Recent Hip Fracture
| Autor: | An Sermon, Guoqin Su, Kenneth W. Lyles, Cathleen S. Colón-Emeric, Patrick Haentjens, Jean-Marc Kaufman, Christina Bucci-Rechtweg, Frank Claessens, Koen Milisen, Jay Magaziner, Richard Witvrouw, Dirk Vanderschueren, Steven Boonen, Jonathan D. Adachi, Eric S. Orwoll, René Rizzoli |
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| Rok vydání: | 2011 |
| Předmět: |
Male
medicine.medical_specialty Time Factors Osteoporosis Urology Placebo Zoledronic Acid Loading dose Drug Administration Schedule law.invention Absorptiometry Photon Double-Blind Method Randomized controlled trial Bone Density law Prevalence medicine Humans Aged Femoral neck Bone mineral Hip fracture Bone Density Conservation Agents Diphosphonates Dose-Response Relationship Drug Hip Fractures business.industry Incidence Imidazoles medicine.disease Surgery Treatment Outcome medicine.anatomical_structure Zoledronic acid ddc:618.97 Injections Intravenous Female Geriatrics and Gerontology business Follow-Up Studies medicine.drug |
| Zdroj: | Journal of the American Geriatrics Society, Vol. 59, No 11 (2011) pp. 2084-2090 |
| ISSN: | 0002-8614 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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