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Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis.
- Source :
-
The New England journal of medicine [N Engl J Med] 2007 May 03; Vol. 356 (18), pp. 1809-22. - Publication Year :
- 2007
-
Abstract
- Background: A single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis. We assessed the effects of annual infusions of zoledronic acid on fracture risk during a 3-year period.<br />Methods: In this double-blind, placebo-controlled trial, 3889 patients (mean age, 73 years) were randomly assigned to receive a single 15-minute infusion of zoledronic acid (5 mg) and 3876 were assigned to receive placebo at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. Primary end points were new vertebral fracture (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes.<br />Results: Treatment with zoledronic acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the zoledronic-acid group vs. 10.9% in the placebo group; relative risk, 0.30; 95% confidence interval [CI], 0.24 to 0.38) and reduced the risk of hip fracture by 41% (1.4% in the zoledronic-acid group vs. 2.5% in the placebo group; hazard ratio, 0.59; 95% CI, 0.42 to 0.83). Nonvertebral fractures, clinical fractures, and clinical vertebral fractures were reduced by 25%, 33%, and 77%, respectively (P<0.001 for all comparisons). Zoledronic acid was also associated with a significant improvement in bone mineral density and bone metabolism markers. Adverse events, including change in renal function, were similar in the two study groups. However, serious atrial fibrillation occurred more frequently in the zoledronic acid group (in 50 vs. 20 patients, P<0.001).<br />Conclusions: A once-yearly infusion of zoledronic acid during a 3-year period significantly reduced the risk of vertebral, hip, and other fractures. (ClinicalTrials.gov number, NCT00049829.)<br /> (Copyright 2007 Massachusetts Medical Society.)
- Subjects :
- Aged
Aged, 80 and over
Atrial Fibrillation chemically induced
Biomarkers metabolism
Bone Density drug effects
Bone Density Conservation Agents adverse effects
Diphosphonates adverse effects
Double-Blind Method
Drug Administration Schedule
Female
Fractures, Bone epidemiology
Hip Fractures epidemiology
Hip Fractures prevention & control
Humans
Imidazoles adverse effects
Incidence
Infusions, Intravenous
Risk
Spinal Fractures epidemiology
Spinal Fractures prevention & control
Zoledronic Acid
Bone Density Conservation Agents administration & dosage
Diphosphonates administration & dosage
Fractures, Bone prevention & control
Imidazoles administration & dosage
Osteoporosis, Postmenopausal drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1533-4406
- Volume :
- 356
- Issue :
- 18
- Database :
- MEDLINE
- Journal :
- The New England journal of medicine
- Publication Type :
- Academic Journal
- Accession number :
- 17476007
- Full Text :
- https://doi.org/10.1056/NEJMoa067312