利塞膦酸钠对绝经后妇女骨密度影响的随机双盲多中心对照临床研究

Randomized,double-blind,multicenter comparative clinical trial of risedronate on bone mineral density in Chinese postmenopausal women

目的研究国产盐酸利塞膦酸钠(第3代双膦酸盐类抗骨吸收剂)对绝经后妇女骨密度(BMD)及骨代谢的影响。方法用多中心、随机、双盲安慰剂对照临床研究,240名绝经后妇女每天接受利塞膦酸钠5mg(n=120),或安慰剂(n=120),治疗12个月;每位受试者于服药前及服药12个月后,各进行1次BMD、血生化指标的测定,骨代谢标志物在用药前及用药后6个月测定。结果利塞膦酸钠组腰椎BMD百分数增加4.83%;而安慰剂组增加1.15%(P<0.001)。利塞膦酸钠髋部BMD增加3.52%;而安慰剂组增加1.84%(P<0.01)。利塞膦酸钠组骨代谢指标血清骨钙素上升23.1%;而安慰剂组上升37.1%(P<0.05),2组C-端交联肽分别降低72.7%和40.6%(P<0.001)。结论利塞膦酸钠能增加绝经后妇女骨密度并降低了骨吸收指标。

Objective To determine the effect of risedronate on bone mineral density （BMD） , bone metabolism markers in Chinese postmenopausal women. Methods This was a multicenter, randomized, double blind placebo controlled study in China with a total of 240 postmenopausal women treated with either risedronate 5 mg （n = 120） or placebo （n = 120） daily for 12 months. BMD, bone markers were determined before and after drug administration. Results The percentage increase in total lumbar spine BMD was 4.83 % with risedronate compared to increase of 1.15% with placebo （P 〈 0.01 ）. Corresponding values for total hip BMD were 3.52% increase for risedronate and 1.84% for placebo （P 〈 0.001 ） . For biochemical markers of bone metabolism, serum osteocalcin were 23.1% increase and C -telopeptide 72.7% decrease in risedronate -treated subjects, and corresponding values in placebo were 37.1% increase and 40.6% decrease （ risedronate compared to placebo, P 〈 0.05, P 〈 0. 001 ）. Conclusion This study confirms that risedronate exerts positive effects on the skeleton, increasing BMD and decreasing absorptive biochemical markers of bone metabolism.