title: Fracture risk and zoledronic acid therapy in men with osteoporosis.
abstract: Fractures in men are a major health issue, and data on the antifracture efficacy of therapies for osteoporosis in men are limited. We studied the effect of zoledronic acid on fracture risk among men with osteoporosis.
  
  
  
  In this multicenter, double-blind, placebo-controlled trial, we randomly assigned 1199 men with primary or hypogonadism-associated osteoporosis who were 50 to 85 years of age to receive an intravenous infusion of zoledronic acid (5 mg) or placebo at baseline and at 12 months. Participants received daily calcium and vitamin D supplementation. The primary end point was the proportion of participants with one or more new morphometric vertebral fractures over a period of 24 months.
  
  
  
  The rate of any new morphometric vertebral fracture was 1.6% in the zoledronic acid group and 4.9% in the placebo group over the 24-month period, representing a 67% risk reduction with zoledronic acid (relative risk, 0.33; 95% confidence interval, 0.16 to 0.70; P=0.002). As compared with men who received placebo, men who received zoledronic acid had fewer moderate-to-severe vertebral fractures (P=0.03) and less height loss (P=0.002). Fewer participants who received zoledronic acid had clinical vertebral or nonvertebral fractures, although this difference did not reach significance because of the small number of fractures. Bone mineral density was higher and bone-turnover markers were lower in the men who received zoledronic acid (P<0.05 for both comparisons). Results were similar in men with low serum levels of total testosterone. The zoledronic acid and placebo groups did not differ significantly with respect to the incidence of death (2.6% and 2.9%, respectively) or serious adverse events (25.3% and 25.2%).
  
  
  
  Zoledronic acid treatment was associated with a significantly reduced risk of vertebral fracture among men with osteoporosis. (Funded by Novartis Pharma; ClinicalTrials.gov number, NCT00439647.).
authors.affiliation: Katholieke Universiteit Leuven, Leuven, Belgium. en.boonen@uz.kuleuven.ac.be
authors.forename: Steven
authors.initials: S
authors.lastname: Boonen
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Reginster
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Kaufman
authors.forename: Kurt
authors.initials: K
authors.lastname: Lippuner
authors.forename: Jose
authors.initials: J
authors.lastname: Zanchetta
authors.forename: Bente
authors.initials: B
authors.lastname: Langdahl
authors.forename: Rene
authors.initials: R
authors.lastname: Rizzoli
authors.forename: Stanley
authors.initials: S
authors.lastname: Lipschitz
authors.forename: Hans Peter
authors.initials: HP
authors.lastname: Dimai
authors.forename: Richard
authors.initials: R
authors.lastname: Witvrouw
authors.forename: Erik
authors.initials: E
authors.lastname: Eriksen
authors.forename: Kim
authors.initials: K
authors.lastname: Brixen
authors.forename: Luis
authors.initials: L
authors.lastname: Russo
authors.forename: Frank
authors.initials: F
authors.lastname: Claessens
authors.forename: Philemon
authors.initials: P
authors.lastname: Papanastasiou
authors.forename: Oscar
authors.initials: O
authors.lastname: Antunez
authors.forename: Guoqin
authors.initials: G
authors.lastname: Su
authors.forename: Christina
authors.initials: C
authors.lastname: Bucci-Rechtweg
authors.forename: Josef
authors.initials: J
authors.lastname: Hruska
authors.forename: Elodie
authors.initials: E
authors.lastname: Incera
authors.forename: Dirk
authors.initials: D
authors.lastname: Vanderschueren
authors.forename: Eric
authors.initials: E
authors.lastname: Orwoll
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D004164:Diphosphonates / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D007006:Hypogonadism / Q000150:complications; D007093:Imidazoles / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy* / Q000209:etiology; D012306:Risk; D016103:Spinal Fractures / Q000453:epidemiology / Q000517:prevention & control*; D013739:Testosterone / Q000097:blood; D000077211:Zoledronic Acid
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D013739:Testosterone; D000077211:Zoledronic Acid