Alendronate produces greater effects than raloxifene on bone density and bone turnover in postmenopausal women with low bone density:: results of EFFECT (EFficacy of FOSAMAX® versus EVISTA® Comparison Trial) International
Alendronate produces greater effects than raloxifene on bone density and bone turnover in postmenopausal women with low bone density:: results of EFFECT (EFficacy of FOSAMAX® versus EVISTA® Comparison Trial) International
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DOI：
10.1111/j.1365-2796.2004.01317.x
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发表时间：
2004-04-01
影响因子：
11.1
通讯作者：
Melton, ME
中科院分区：
文献类型：
--
作者：
Sambrook, PN;Geusens, P;Melton, ME
目标。阿伦磷酸钠和雷洛昔芬是具有不同作用机制的抗吸收药，各自用于治疗绝经后妇女的骨质疏松症。本研究旨在比较阿仑磷酸钠与雷洛昔芬治疗低骨密度绝经后妇女的疗效和耐受性。随机、双掩码、双模拟、多中心国际研究。欧洲、南美和亚太地区的临床试验中心。根据腰椎或髋部的骨密度(BMD)(T评分小于或等于-2.0)，共有487名绝经后妇女患有低骨密度。患者每周服用70毫克阿伦磷酸钠，每日服用雷洛昔芬相同的安慰剂，或服用雷洛昔芬60毫克，每周服用与阿伦磷酸钠相同的安慰剂，为期12个月。评估包括腰椎和髋部的骨密度，6个月和12个月时的骨转换标志和不良事件报告。12个月后，阿仑磷酸钠在腰椎和髋部的骨密度增加幅度明显大于雷洛昔芬。服用阿仑磷酸钠的患者腰椎骨密度增加了4.8%，而服用雷洛昔芬的患者增加了2.2%(P<；0.001)。服用阿伦磷酸钠的患者髋部骨密度增加2.3%，而服用雷洛昔芬的患者增加0.8%(P<；0.001)。与雷洛昔芬相比，服用阿伦磷酸钠的患者骨转换降低幅度明显更大。总体耐受性相似，然而，服用雷洛昔芬的患者报告血管运动事件的比例(9.5%)显著高于服用阿伦磷酸钠的患者(3.7%，P=0.010)。患者报告胃肠道事件的比例在不同组之间相似。在骨密度低的绝经后妇女中，与雷洛昔芬相比，阿伦磷酸钠治疗期间骨密度和骨转换标志物的改善显著大于雷洛昔芬。
Objectives. Alendronate and raloxifene are antiresorptive agents with different mechanisms of action, each used to treat osteoporosis in postmenopausal women. This study was undertaken to compare the efficacy and tolerability of alendronate to raloxifene in postmenopausal women with low-bone density.Design. Randomized, double-masked, double-dummy multicentre international study.Setting. Clinical trial centres in Europe, South America and Asia-Pacific.Subjects. A total of 487 postmenopausal women with low bone density, based on bone mineral density (BMD) of the lumbar spine or hip (T-score less than or equal to-2.0).Interventions. Patients received either alendronate 70 mg once weekly and daily placebo identical to raloxifene or raloxifene 60 mg daily and weekly placebo identical to alendronate for 12 months.Main outcome measures. Evaluations included BMD of the lumbar spine and hip and markers of bone turnover at 6 and 12 months and adverse event reporting.Results. Alendronate demonstrated substantially greater increases in BMD than raloxifene at both lumbar spine and hip sites at 12 months. Lumbar spine BMD increased 4.8% with alendronate vs. 2.2% with raloxifene (P < 0.001). The increase in total hip BMD was 2.3% with alendronate vs. 0.8% with raloxifene (P < 0.001). Reductions in bone turnover were significantly larger with alendronate than raloxifene. Overall tolerability was similar, however, the proportion of patients reporting vasomotor events was significantly higher with raloxifene (9.5%) than with alendronate (3.7%, P = 0.010). The proportion of patients reporting gastrointestinal events was similar between groups.Conclusion. In postmenopausal women with low bone density, improvements in BMD and markers of bone turnover were substantially greater during treatment with alendronate compared to raloxifene.