Fracture risk and zoledronic acid therapy in men with osteoporosis

Aged; Aged, 80 and over; Analysis of Variance; Bone Density; Bone Density Conservation Agents; Diphosphonates; Double-Blind Method; Humans; Hypogonadism; Imidazoles; Logistic Models; Male; Middle Aged; Osteoporosis; Risk; Spinal Fractures; Testosterone

Abstract :

[en] BACKGROUND: 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. METHODS: 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. RESULTS: 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%). CONCLUSIONS: 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.) Copyright © 2012 Massachusetts Medical Society.

Disciplines :

General & internal medicine

Author, co-author :

Boonen, S.; Katholieke Universiteit Leuven, Leuven, Belgium

REGINSTER, Jean-Yves ; Centre Hospitalier Universitaire de Liège - CHU > Médecine de l'appareil locomoteur

Kaufman, J.-M.; Ghent University, Ghent, Belgium

Lippuner, K.; University of Bern, Bern, Switzerland

Zanchetta, J.; Universidad del Salvador, Buenos Aires, Argentina

Langdahl, B.; Aarhus University Hospital, Aarhus, Denmark

Rizzoli, R.; Rehabilitation and Geriatrics, Geneva University Hospitals, Geneva, Switzerland

Lipschitz, S.; Bone Mineral Density Clinic, Johannesburg, South Africa

Dimai, H. P.; Medical University of Graz, Graz, Austria

Witvrouw, R.; Ziekenhuis Oost-Limburg, Genk, Belgium

More authors (12 more)

Language :

English

Title :

Fracture risk and zoledronic acid therapy in men with osteoporosis

Publication date :

2012

Journal title :

New England Journal of Medicine

ISSN :

0028-4793

eISSN :

1533-4406

Publisher :

Massachusetts Medical Society, United States - Massachusetts

Volume :

367

Issue :

Pages :

1714-1723

Peer reviewed :

Peer Reviewed verified by ORBi

Available on ORBi :

since 17 October 2013

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