Delmas P D, Benhamou C L, Man Z, Tlustochowicz W, Matzkin E, Eusebio R, Zanchetta J, Olszynski W P, Recker R R, McClung M R
University of Lyon and INSERM Research Unit 831, Lyon, France.
Osteoporos Int. 2008 Jul;19(7):1039-45. doi: 10.1007/s00198-007-0531-9. Epub 2007 Dec 18.
Postmenopausal women with osteoporosis received 75 mg risedronate on two consecutive days each month or 5 mg daily for 12 months. Changes in bone mineral density and bone turnover markers were similar between treatments. Risedronate 75 mg twice monthly was effective and safe suggesting a new, convenient dosing schedule.
Patients perceive less frequent dosing as being more convenient. This 2-year trial evaluates the efficacy and safety of a new monthly oral regimen of risedronate; 1 year results are presented here.
Postmenopausal women with osteoporosis (n = 1229) were randomly assigned to double-blind treatment with 75 mg risedronate on two consecutive days each month (2CDM), or 5 mg daily. The primary endpoint was the percent change from baseline in lumbar spine (LS) bone mineral density (BMD) at month 12. Secondary efficacy was evaluated by mean percent changes from baseline in BMD in LS, total hip, trochanter, and femoral neck, and bone turnover markers (BTMs).
Risedronate 75 mg 2CDM was non-inferior to 5 mg daily (treatment difference 0.21; 95% CI -0.19 to 0.62). Mean percent change in LS-BMD was 3.4% +/- 0.16 and 3.6% +/- 0.15 respectively. Mean percent changes in BMD and BTMs were significant and similar for both treatment groups. New vertebral fractures occurred in 1% of subjects with either treatment. Both treatments were generally well tolerated and safe.
Risedronate 75 mg 2CDM was non-inferior in efficacy and did not show a difference in safety vs. 5 mg daily after 12 months, leading to a similar benefit.
患有骨质疏松症的绝经后女性每月连续两天接受75毫克利塞膦酸盐治疗，或每日接受5毫克治疗，持续12个月。两种治疗方法在骨矿物质密度和骨转换标志物方面的变化相似。每月两次75毫克利塞膦酸盐有效且安全，提示一种新的、方便的给药方案。
患者认为给药频率较低更方便。这项为期两年的试验评估了一种新的每月口服利塞膦酸盐方案的疗效和安全性；此处展示1年的结果。
患有骨质疏松症的绝经后女性（n = 1229）被随机分配至双盲治疗组，一组每月连续两天接受75毫克利塞膦酸盐（2CDM）治疗，另一组每日接受5毫克治疗。主要终点是第12个月时腰椎（LS）骨矿物质密度（BMD）相对于基线的变化百分比。通过LS、全髋、大转子和股骨颈BMD相对于基线的平均变化百分比以及骨转换标志物（BTM）来评估次要疗效。
每月两次75毫克利塞膦酸盐（2CDM）不劣于每日5毫克（治疗差异0.21；95%可信区间 -0.19至0.62）。LS-BMD的平均变化百分比分别为3.4%±0.16和3.6%±0.15。两个治疗组BMD和BTM的平均变化百分比均显著且相似。两种治疗中的任何一种治疗均有1%的受试者发生新的椎体骨折。两种治疗总体耐受性良好且安全。
每月两次75毫克利塞膦酸盐（2CDM）在疗效上不劣于每日5毫克，且在12个月后安全性方面无差异，带来相似的益处。
