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Fracture risk and zoledronic acid therapy in men with osteoporosis.
- Source :
-
The New England journal of medicine [N Engl J Med] 2012 Nov 01; Vol. 367 (18), pp. 1714-23. - Publication Year :
- 2012
-
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.<br />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.<br />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%).<br />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.).
- Subjects :
- 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 etiology
Risk
Spinal Fractures epidemiology
Testosterone blood
Zoledronic Acid
Bone Density Conservation Agents therapeutic use
Diphosphonates therapeutic use
Imidazoles therapeutic use
Osteoporosis drug therapy
Spinal Fractures prevention & control
Subjects
Details
- Language :
- English
- ISSN :
- 1533-4406
- Volume :
- 367
- Issue :
- 18
- Database :
- MEDLINE
- Journal :
- The New England journal of medicine
- Publication Type :
- Academic Journal
- Accession number :
- 23113482
- Full Text :
- https://doi.org/10.1056/NEJMoa1204061