Ten years' experience with alendronate for osteoporosis in postmenopausal women
Ten years' experience with alendronate for osteoporosis in postmenopausal women
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DOI：
10.1056/nejmoa030897
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发表时间：
2004-03-18
影响因子：
158.5
通讯作者：
Liberman, UA
中科院分区：
文献类型：
--
作者：
Bone, HG;Hosking, D;Liberman, UA
背景：抗吸收药物被广泛用于治疗骨质疏松症。我们报道了一项多国随机双盲研究的结果，在这项研究中，患有骨质疏松症的绝经后妇女接受阿伦磷酸钠长达10年的治疗。方法：该研究的最初三年阶段比较了每天服用三种剂量的阿伦磷酸钠与安慰剂。最初的安慰剂组的妇女在第4年和第5年接受阿伦磷酸钠治疗，然后出院。最初的积极治疗组的妇女在最初的延长期间(第4年和第5年)继续接受阿伦磷酸钠的治疗。在进一步的两个延长期(6年和7年，以及8年到10年)中，每天接受5毫克或10毫克阿伦磷酸钠的妇女继续接受相同的治疗。停药组的女性在两年内每天服用20毫克阿伦磷酸钠，在第3、4、5年每天服用5毫克，然后服用5年的安慰剂。在整个10年中，随机分组和盲法保持不变。结果：连续10年每天服用10毫克阿仑磷酸钠，腰椎骨密度平均增加13.7%(95%可信区间，12.0~15.5%)，粗隆骨密度平均增加10.3%(95%可信区间，8.1~12.4%)，股骨颈骨密度平均增加5.4%(95%可信区间，3.5%~7.4%)，股骨近端骨密度平均增加6.7%(95%可信区间，3.5%~7.4%)，股骨近端骨密度平均增加6.7%(95%可信区间，8.1%至12.4%)，整个股骨近端骨密度平均增加6.7%(95%可信区间，3.5%至7.4%)。4.4%至9.1%)与基线值相比；每天服用5毫克的那一组出现了较小的增长。根据骨密度和骨重建生化标记物的测量，停用阿伦磷酸钠会导致作用的逐渐丧失。包括骨折和身高在内的安全性数据表明，延长治疗时间并不会导致任何益处的丧失。结论：阿仑磷酸钠的治疗效果是持久的，并且该药物在10年内耐受性良好。阿伦磷酸钠的停用导致其作用逐渐丧失。
Background: Antiresorptive agents are widely used to treat osteoporosis. We report the results of a multinational randomized, double-blind study, in which postmenopausal women with osteoporosis were treated with alendronate for up to 10 years.Methods: The initial three-year phase of the study compared three daily doses of alendronate with placebo. Women in the original placebo group received alendronate in years 4 and 5 and then were discharged. Women in the original active-treatment groups continued to receive alendronate during the initial extension (years 4 and 5). In two further extensions (years 6 and 7, and 8 through 10), women who had received 5 mg or 10 mg of alendronate daily continued on the same treatment. Women in the discontinuation group received 20 mg of alendronate daily for two years and 5 mg daily in years 3, 4, and 5, followed by five years of placebo. Randomized group assignments and blinding were maintained throughout the 10 years. We report results for the 247 women who participated in all four phases of the study.Results: Treatment with 10 mg of alendronate daily for 10 years produced mean increases in bone mineral density of 13.7 percent at the lumbar spine (95 percent confidence interval, 12.0 to 15.5 percent), 10.3 percent at the trochanter (95 percent confidence interval, 8.1 to 12.4 percent), 5.4 percent at the femoral neck (95 percent confidence interval, 3.5 to 7.4 percent), and 6.7 percent at the total proximal femur (95 percent confidence interval, 4.4 to 9.1 percent) as compared with base-line values; smaller gains occurred in the group given 5 mg daily. The discontinuation of alendronate resulted in a gradual loss of effect, as measured by bone density and biochemical markers of bone remodeling. Safety data, including fractures and stature, did not suggest that prolonged treatment resulted in any loss of benefit.Conclusions: The therapeutic effects of alendronate were sustained, and the drug was well tolerated over a 10-year period. The discontinuation of alendronate resulted in the gradual loss of its effects.