Effect of risedronate on the risk of hip fracture in elderly women
Effect of risedronate on the risk of hip fracture in elderly women
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DOI：
10.1056/nejm200102013440503
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发表时间：
2001-02-01
影响因子：
158.5
通讯作者：
Chestnut, CH
中科院分区：
文献类型：
--
作者：
McClung, MR;Geusens, P;Chestnut, CH
背景资料：利塞膦酸钠增加老年妇女的骨密度，但它是否能预防髋部骨折尚不清楚。方法：我们研究了5445名70至79岁患有骨质疏松症的妇女（由股骨颈骨矿物质密度的T评分表示，该评分比年轻成人的平均峰值[-4]低4 SD以上或低于-3加上髋部骨折的非骨骼风险因素，如步态不稳或易跌倒）和3886名至少80岁的女性，这些女性至少有一个髋部骨折或股骨颈骨密度低的非骨骼危险因素（T评分，低于-4或低于-3加上髋轴长度11.1 cm或更长）。这些妇女被随机分配接受口服利塞膦酸钠（每天2.5或5.0毫克）或安慰剂治疗三年。主要终点是髋部骨折的发生率。结果：总体而言，在所有分配到利塞膦酸钠组的妇女中，髋部骨折的发生率为2.8%，而在分配到安慰剂组的妇女中，髋部骨折的发生率为3.9%（相对危险度为0.7; 95%置信区间为0.6 - 0.9; P=0.02）。在骨质疏松症妇女组（70 - 79岁）中，利塞膦酸钠组髋部骨折的发生率为1.9%，而安慰剂组为3.2%（相对危险度为0.6; 95%可信区间为0.4 - 0.9; P=0.009）。在主要根据非骨骼风险因素选择的妇女组中，（年龄在80岁以上），髋部骨折的发生率在利塞膦酸钠组为4.2%，安慰剂组为5.1%（P=0.35）。结论：利塞膦酸钠可显著降低确诊骨质疏松的老年女性髋部骨折的风险，但在主要选择的老年女性中没有基于低骨密度以外的风险因素。（N Engl J Med 2001;344：333-40.）版权所有（C）2001马萨诸塞州医学会。
Background: Risedronate increases bone mineral density in elderly women, but whether it prevents hip fracture is not known.Methods: We studied 5445 women 70 to 79 years old who had osteoporosis (indicated by a T score for bone mineral density at the femoral neck that was more than 4 SD below the mean peak value in young adults [-4] or lower than -3 plus a nonskeletal risk factor for hip fracture, such as poor gait or a propensity to fall) and 3886 women at least 80 years old who had at least one nonskeletal risk factor for hip fracture or low bone mineral density at the femoral neck (T score, lower than -4 or lower than -3 plus a hip-axis length of 11.1 cm or greater). The women were randomly assigned to receive treatment with oral risedronate (2.5 or 5.0 mg daily) or placebo for three years. The primary end point was the occurrence of hip fracture.Results: Overall, the incidence of hip fracture among all the women assigned to risedronate was 2.8 percent, as compared with 3.9 percent among those assigned to placebo (relative risk, 0.7; 95 percent confidence interval, 0.6 to 0.9; P=0.02). In the group of women with osteoporosis (those 70 to 79 years old), the incidence of hip fracture among those assigned to risedronate was 1.9 percent, as compared with 3.2 percent among those assigned to placebo (relative risk, 0.6; 95 percent confidence interval, 0.4 to 0.9; P=0.009). In the group of women selected primarily on the basis of nonskeletal risk factors (those at least 80 years of age), the incidence of hip fracture was 4.2 percent among those assigned to risedronate and 5.1 percent among those assigned to placebo (P=0.35).Conclusions: Risedronate significantly reduces the risk of hip fracture among elderly women with confirmed osteoporosis but not among elderly women selected primarily on the basis of risk factors other than low bone mineral density. (N Engl J Med 2001;344:333-40.) Copyright (C) 2001 Massachusetts Medical Society.