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Once-weekly risedronate in men with osteoporosis: results of a 2-year, placebo-controlled, double-blind, multicenter study.
Once-weekly risedronate in men with osteoporosis: results of a 2-year, placebo-controlled, double-blind, multicenter study.
- Source :
-
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research [J Bone Miner Res] 2009 Apr; Vol. 24 (4), pp. 719-25. - Publication Year :
- 2009
-
Abstract
- Male osteoporosis is increasingly recognized as a major public health issue. This multinational, 2-yr, randomized, double-blind, placebo-controlled study was conducted to determine the efficacy and safety of 35 mg once-a-week risedronate in men with osteoporosis. Patients had to be men >or=30 yr old, with lumbar spine T-score <or= -2.5 and femoral neck T-score <or= -1 SD or lumbar spine T-score <or= -1 and femoral neck T-score <or= -2 SD (based on young normal men). Patients were randomized 2:1 to risedronate 35 mg once a week or placebo for 2 yr; all patients took 1000 mg elemental calcium and 400-500 IU vitamin D daily. Lumbar spine BMD at month 24 using last observation carried forward was the primary endpoint. Other endpoints included lumbar spine BMD at time points other than month 24, proximal femur BMD, bone turnover markers (BTMs), new vertebral fractures, clinical fractures, and adverse event (AE) assessment. There were 284 men enrolled in the study. Treatment with risedronate resulted in a significant increase from baseline to endpoint in lumbar spine BMD compared with placebo (4.5%; 95% CI: 3.5%, 5.6%; p < 0.001). Few new vertebral and nonvertebral fractures were reported, with no differences in fracture rates between the two groups. There was a significant (p < 0.01) reduction from baseline in BTMs for the risedronate group compared with placebo at all time points. No apparent differences in the pattern or distribution of AEs including serious and upper gastrointestinal AEs were observed. Risedronate therapy was well tolerated during this 2-yr study and was rapidly effective as indicated by significant BTM decreases at month 3 and BMD increases at month 6 (the earliest time points tested). The effects of risedronate treatment on BMD and BTMs in this study were similar to those previously shown to be associated with fracture risk reductions in women with postmenopausal osteoporosis.
- Subjects :
- Adult
Aged
Aged, 80 and over
Bone Density drug effects
Bone Density physiology
Bone Density Conservation Agents adverse effects
Bone Density Conservation Agents pharmacology
Double-Blind Method
Drug Administration Schedule
Etidronic Acid administration & dosage
Etidronic Acid adverse effects
Etidronic Acid pharmacology
Etidronic Acid therapeutic use
Humans
Least-Squares Analysis
Lumbar Vertebrae drug effects
Lumbar Vertebrae physiopathology
Male
Middle Aged
Osteoporosis physiopathology
Placebos
Risedronic Acid
Treatment Outcome
Bone Density Conservation Agents administration & dosage
Bone Density Conservation Agents therapeutic use
Etidronic Acid analogs & derivatives
Osteoporosis drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1523-4681
- Volume :
- 24
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research
- Publication Type :
- Academic Journal
- Accession number :
- 19049326
- Full Text :
- https://doi.org/10.1359/jbmr.081214