Effect of alendronate on vertebral fracture risk in women with bone mineral density T scores of -1.6 to -2.5 at the femoral neck: The Fracture Intervention Trial
Effect of alendronate on vertebral fracture risk in women with bone mineral density T scores of -1.6 to -2.5 at the femoral neck: The Fracture Intervention Trial
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DOI：
10.4065/80.3.343
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发表时间：
2005-03-01
影响因子：
8.9
通讯作者：
Black, DM
中科院分区：
文献类型：
--
作者：
Quandt, SA;Thompson, DE;Black, DM
目的：确定阿仑膦酸钠治疗对来自骨折干预试验的股骨颈骨矿物质密度 T 评分在 -1.6 至 -2.5 之间的女性亚组的椎骨骨折风险的疗效，并描述开始治疗后阿仑膦酸钠多久生效，以及它在患有或不患有放射学椎体骨折的女性中是否一致。 患者和方法：从 1992 年 5 月到 3 月1997 年，在一项对照、双盲、多中心研究中，年龄 55 至 80 岁的绝经后妇女被随机接受阿仑膦酸钠 5 mg/d，持续 2 年，随后接受 10 mg/d，或安慰剂长达 4.5 年（平均 3.8 年）。 结果：总共 3737 名绝经后妇女被纳入研究，其中 1878 名绝经后妇女接受阿仑膦酸钠治疗。组和安慰剂组 1859。与安慰剂相比，阿仑膦酸钠显着降低了临床骨折（相对风险 [RR]，0.40；95% 置信区间 [CI]，0.19-0.76；P=.005）和放射学骨折（RR，0.57；95% CI，0.41-0.81；P=.002）骨折的风险。临床（RR，0.34；95% CI，0.12-0.84；和 RR，0.46；95% CI，0.16-1.17）和放射学（RR，0.53；95% CI，0.34-0.82；和 RR， 0.64；95% CI，0.38-1.10；骨折。在两组中，治疗开始后不久就注意到阿仑膦酸钠对临床椎骨骨折的影响。没有基线放射线骨折的女性，椎骨骨折的绝对风险较低。结论：对于不符合骨质疏松症骨密度标准的低骨量女性，阿仑膦酸钠可有效降低椎骨骨折的风险。对于 T 评分在 -1.6 和 -2.5 之间的女性，这种疗法的绝对益处对于现有椎骨骨折和/或具有其他危险因素的女性来说更大。阿仑膦酸钠的作用发生较早。
OBJECTIVES: To determine the efficacy of alendronate treatment on risk of vertebral fracture in a subgroup of women from the Fracture Intervention Trial who had bone mineral density T scores between -1.6 and -2.5 at the femoral neck and to describe how soon after initiation of therapy alendronate becomes effective and whether it is consistent in women with and without existing radiographic vertebral fracture.PATIENTS AND METHODS: From May 1992 to March 1997, postmenopausal women aged 55 to 80 years were randomized to receive alendronate at 5 mg/d for 2 years and 10 mg/d thereafter or placebo for up to 4.5 years (mean, 3.8 years) in a controlled, double-blind, multicenter study.RESULTS: A total of 3737 postmenopausal women were included in the study, 1878 in the alendronate group and 1859 in the placebo group. Risk of vertebral fracture was significantly reduced by alendronate compared with placebo for clinical (relative risk [RR], 0.40; 95% confidence interval [CI], 0.19-0.76; P=.005) and radiographic (RR, 0.57; 95% CI, 0.41-0.81; P=.002) fracture. The reductions in vertebral fracture risk were consistent in women with and without an existing radiographic vertebral fracture for clinical (RR, 0.34; 95% CI, 0.12-0.84; and RR, 0.46; 95% CI, 0.16-1.17; respectively) and radiographic (RR, 0.53; 95% CI, 0.34-0.82; and RR, 0.64; 95% CI, 0.38-1.10; respectively) fractures. In both groups, the effect of alendronate on clinical vertebral fracture was noted soon after therapy was initiated. The absolute risk of vertebral fracture was low in women without a baseline radiographic fracture.CONCLUSIONS: In women with low bone mass who do not meet the bone mineral density criterion for osteoporosis, alendronate is effective in reducing the risk of vertebral fractures. The absolute benefit of this therapy in women with a T score between -1.6 and -2.5 is greater in women with an existing vertebral fracture and/or with other risk factors. The effect of alendronate occurs early.