作者: David M Reid , David Hosking , David Kendler , Maria L Brandi , John D Wark
DOI: 10.2165/00044011-200626020-00002
关键词: Femoral neck 、 Osteoporosis 、 Bone density 、 Bone remodeling 、 Medicine 、 Alendronic acid 、 Risedronic acid 、 Tolerability 、 Urology 、 Bone mineral
摘要: Background: The objective of the study was to evaluate effects alendronic acid once weekly relative risedronic on bone mineral density (BMD), markers turnover and tolerability in treatment osteoporosis postmenopausal women. Methods: This a randomised, double-masked, double-dummy multicentre international (75 centres 27 countries Europe, Americas Asia-Pacific). A total 1303 women were screened 936 with low (T-score ≤−2.0 at spine, hip trochanter, or femoral neck) randomised; 91% (n = 854) completed study. Patients randomised either active 70mg (Fosamax®) placebo identical 35mg (Actonel®) for 12 months. primary efficacy endpoint percentage change from baseline trochanter BMD Secondary endpoints included lumbar neck BMD; biochemical (including serum bone-specific alkaline phosphatase [BSAP] urinary type I collagen N-telopeptides [NTx]); safety as assessed by reporting adverse experiences. Results: Alendronic produced greater increases than did months all sites measured. Mean month 3.56% 2.71% groups, respectively (treatment difference [95% CI]: 0.83% [0.22, 1.45; p 0.008]). (p 0.002, < 0.001, 0.039, respectively). Increases compared also significantly 6 hip. There reduction acid: NTx decreased 58% 47% 0.001); BSAP 45% 34% 0.001). Overall upper gastrointestinal similar both agents. Conclusions: spine reductions weekly. Both agents well tolerated no significant Clinicians should consider these results when making decisions osteoporosis.