Risk of fracture among women who lose bone density during treatment with alendronate. The Fracture Intervention Trial
Risk of fracture among women who lose bone density during treatment with alendronate. The Fracture Intervention Trial
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DOI：
10.1007/s00198-004-1770-7
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发表时间：
2005-07-01
影响因子：
4
通讯作者：
Cummings, SR
中科院分区：
文献类型：
--
作者：
Chapurlat, RD;Palermo, L;Cummings, SR
人们普遍认为，患者对阿仑膦酸钠治疗的反应与骨矿物质密度 (BMD) 的增加成正比，而那些在治疗期间失去 BMD 的患者可能对治疗没有反应。在骨折干预试验中，6,459 名女性被随机分配接受阿仑膦酸钠或安慰剂治疗；每年测量一次骨密度，并通过在基线和随访结束时拍摄的侧脊柱片来评估新的脊柱骨折。在服用至少 70% 研究药物的受试者（5,220 名女性）中，我们在调整治疗组和对照组之间的特征差异后，比较了随访结束时（3 或 4 年）脊柱骨折风险的降低情况，以及治疗 1 和 2 年后总髋部和脊柱 BMD 不同水平的变化。与安慰剂组的女性相比，服用阿仑膦酸钠期间腰椎 BMD“丧失”（0% 至 4%）的女性椎骨骨折风险降低了 60% [OR=0.40 (0.16, 0.99)]。少数减重超过 4% 的女性没有显着获益 [OR=0.15 (0.02, 1.29)]。那些在治疗期间“获得”BMD（0% 至 4%）的人的风险降低了 51% [OR=0.49 (0.30, 0.78)]。同样，与服用安慰剂的对照组相比，在服用阿仑膦酸钠的第一年“失去”髋部总 BMD（0% 至 4%）的女性，其椎骨骨折的风险降低了 53% [OR=0.47 (0.27, 0.81)]，而那些“获得”BMD（0% 至 4%）的女性则有类似的风险降低 [OR=0.49 (0.34, 0.71)]。对于少数体重下降超过 4% 的女性，没有观察到这一点 [OR=0.61 (0.11, 3.45)]。髋部和脊柱 BMD 均丧失的患者不受阿仑膦酸钠的保护。在坚持阿仑膦酸钠治疗的患者中，即使是骨密度下降的患者，椎骨骨折的风险也大大降低。因此，阿仑膦酸钠引起的骨转换减少可能比 BMD 变化更重要。少数 BMD 损失最多（每年超过 4%）的女性可能无法从治疗中受益。
It is commonly believed that the response to treatment in patients on alendronate is proportional to the increase in bone mineral density (BMD), and that those who lose BMD during treatment might not respond to treatment. In the Fracture Intervention Trial 6,459 women were randomly assigned to treatment with alendronate or placebo; BMD was measured annually, and new spine fractures were assessed by lateral spine films, taken at baseline and end of follow-up. Among subjects who took at least 70% of the study drug (5,220 women), we compared reductions in risk of spine fractures at end of follow-up (3 or 4 years) within various levels of change in total hip and spine BMD after 1 and 2 years of treatment, after adjustment for differences in characteristics between the treatment and control groups. Women "losing" BMD at the lumbar spine (0% to 4%) while on alendronate had a reduction of 60% in vertebral fracture risk [OR=0.40 (0.16, 0.99)] compared to their counterparts in the placebo group. The few women that lost more than 4% did not have a significant benefit [OR=0.15 (0.02, 1.29)]. Those who "gained" BMD (0% to 4%) during treatment had a reduction in risk of 51% [OR=0.49 (0.30, 0.78)]. Similarly, women who "lost" total hip BMD (0% to 4%) during the first year on alendronate had a 53% decreased risk of vertebral fracture compared to their controls taking placebo [OR=0.47 (0.27, 0.81)], whereas those "gaining" BMD (0% to 4%) had a comparable risk reduction [OR=0.49 (0.34, 0.71)]. This was not observed for the few women who lost more than 4% [OR=0.61 (0.11, 3.45)]. Patients who lost BMD at both the hip and spine were not protected by alendronate. Among patients who adhere to treatment with alendronate, even those who lose BMD benefit from a substantial reduction in risk of vertebral fracture. So, the reduction in bone turnover induced by alendronate might be more important than BMD changes. The few women who lose the most BMD (more than 4% per year) might not benefit from the treatment.