Fracture risk and zoledronic acid therapy in men with osteoporosis.

Details

Serval ID
serval:BIB_4CBE25F58DB6
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Fracture risk and zoledronic acid therapy in men with osteoporosis.
Journal
New England Journal of Medicine
Author(s)
Boonen S., Reginster J.Y., Kaufman J.M., Lippuner K., Zanchetta J., Langdahl B., Rizzoli R., Lipschitz S., Dimai H.P., Witvrouw R., Eriksen E., Brixen K., Russo L., Claessens F., Papanastasiou P., Antunez O., Su G., Bucci-Rechtweg C., Hruska J., Incera E., Vanderschueren D., Orwoll E.
ISSN
1533-4406 (Electronic)
ISSN-L
0028-4793
Publication state
Published
Issued date
2012
Peer-reviewed
Oui
Volume
367
Number
18
Pages
1714-1723
Language
english
Notes
Publication types: Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov'tPublication Status: ppublish Dr LAMY mentionnés dans Supplementary Material > Supplementary Appendix > PAGE 3.
Abstract
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.).
Keywords
Aged, Aged, 80 and over, Analysis of Variance, Bone Density/drug effects, Bone Density Conservation Agents/adverse effects, Bone Density Conservation Agents/pharmacology, Diphosphonates/adverse effects, Diphosphonates/pharmacology, Double-Blind Method, Humans, Hypogonadism/complications, Imidazoles/adverse effects, Imidazoles/pharmacology, Logistic Models, Male, Middle Aged, Osteoporosis/drug therapy, Osteoporosis/etiology, Risk, Spinal Fractures/epidemiology, Spinal Fractures/prevention & control, Testosterone/blood
Pubmed
Web of science
Create date
29/10/2014 17:42
Last modification date
20/08/2019 15:01
Usage data