title: Once-yearly zoledronic acid in older men compared with women with recent hip fracture.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Randomized, placebo-controlled, double-blind trial.
  
  
  METHODS
  International multicenter.
  
  
  METHODS
  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).
  
  
  METHODS
  Once-yearly intravenous (IV) ZOL 5 mg (n = 248) or placebo (n = 260), loading dose of vitamin D, daily calcium, and vitamin D supplements.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Center for Musculoskeletal Research, Leuven University, Leuven, Belgium. boonen@uz.kuleuven.ac.be
authors.forename: Steven
authors.initials: S
authors.lastname: Boonen
authors.forename: Eric
authors.initials: E
authors.lastname: Orwoll
authors.forename: Jay
authors.initials: J
authors.lastname: Magaziner
authors.forename: Cathleen S
authors.initials: CS
authors.lastname: Colón-Emeric
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Adachi
authors.forename: Christina
authors.initials: C
authors.lastname: Bucci-Rechtweg
authors.forename: Patrick
authors.initials: P
authors.lastname: Haentjens
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Kaufman
authors.forename: Rene
authors.initials: R
authors.lastname: Rizzoli
authors.forename: Dirk
authors.initials: D
authors.lastname: Vanderschueren
authors.forename: Frank
authors.initials: F
authors.lastname: Claessens
authors.forename: An
authors.initials: A
authors.lastname: Sermon
authors.forename: Richard
authors.initials: R
authors.lastname: Witvrouw
authors.forename: Koen
authors.initials: K
authors.lastname: Milisen
authors.forename: Guoqin
authors.initials: G
authors.lastname: Su
authors.forename: Kenneth W
authors.initials: KW
authors.lastname: Lyles
mesh_terms: D015502:Absorptiometry, Photon; D000368:Aged; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D004164:Diphosphonates / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006620:Hip Fractures / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage*; D015994:Incidence; D007275:Injections, Intravenous; D008297:Male; D010024:Osteoporosis / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D015995:Prevalence; D013997:Time Factors; D016896:Treatment Outcome; D000077211:Zoledronic Acid
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid