Storm T, Thamsborg G, Steiniche T, Genant H K, Sørensen O H
Department of Medicine, Sundby Hospital, Copenhagen, Denmark.
N Engl J Med. 1990 May 3;322(18):1265-71. doi: 10.1056/NEJM199005033221803.
Progressive bone loss in osteoporosis results from bone resorption in excess of bone formation. We conducted a double-blind study in 66 women with postmenopausal osteoporosis of therapy with etidronate, a diphosphonate compound that reduces bone resorption by inhibiting osteoclastic activity. The patients were randomly assigned in equal numbers to receive oral etidronate (400 mg per day) or placebo for 2 weeks, followed by a 13-week period in which no drugs were given. This sequence was repeated 10 times, for a total of 150 weeks. Daily oral supplementation with calcium and vitamin D was given throughout the study to both groups. Vertebral bone mineral content was measured by dual-photon absorptiometry; spinal radiographs were assessed to identify new vertebral fractures. Vertebral bone mineral content increased significantly (P less than 0.01) after 150 weeks of etidronate therapy (5.3 percent; 95 percent confidence interval, 2.0 to 8.6; n = 20) but decreased with placebo (-2.7 percent; 95 percent confidence interval, -7.3 to 1.9; n = 20). The difference between groups was 8.0 percentage points (P less than 0.01; 95 percent confidence interval, 2.4 to 13.6). The rates of fracture were significantly different for the period from week 60 to week 150 between the etidronate and placebo groups (6 vs. 54 fractures per 100 patient-years; P = 0.023). No adverse clinical, biochemical, or bone histomorphometric effects of treatment were observed. We conclude that at the end of nearly three years, etidronate therapy for postmenopausal osteoporosis results in significant increases in vertebral bone mineral content and, after approximately one year of treatment, a significant decrease in the rate of new vertebral fractures.
骨质疏松症中进行性骨质流失是由骨吸收超过骨形成所致。我们对66名绝经后骨质疏松症女性进行了一项双盲研究，采用依替膦酸治疗，依替膦酸是一种双膦酸盐化合物，通过抑制破骨细胞活性来减少骨吸收。患者被随机等分为两组，一组口服依替膦酸（每日400毫克），另一组口服安慰剂，为期2周，随后有13周不服用任何药物。此疗程重复10次，共150周。在整个研究过程中，两组患者均每日口服补充钙和维生素D。采用双能X线吸收法测量椎体骨矿物质含量；通过脊柱X线片评估以确定新的椎体骨折。依替膦酸治疗150周后，椎体骨矿物质含量显著增加（P<0.01）（5.3%；95%置信区间为2.0至8.6；n = 20），而安慰剂组则下降（-2.7%；95%置信区间为-7.至1.9；n = 20）。两组之间的差异为8.0个百分点（P<0.01；95%置信区间为2.4至13.6）。依替膦酸组和安慰剂组在第60周 至第150周期间的骨折发生率有显著差异（每100患者年分别为6例和54例骨折；P = 0.023）。未观察到治疗有不良临床、生化或骨组织形态计量学影响。我们得出结论，在近三年疗程结束时，依替膦酸治疗绝经后骨质疏松症可使椎体骨矿物质含量显著增加，且在治疗约一年后，新椎体骨折发生率显著降低。
