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首页> 外文期刊>Clinical drug investigation >Alendronic Acid Produces Greater Effects than Risedronic Acid on Bone Density and Turnover in Postmenopausal Women with Osteoporosis: Results of FACTS1 1 Fosamax Actonel Comparison Trials. -International
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Alendronic Acid Produces Greater Effects than Risedronic Acid on Bone Density and Turnover in Postmenopausal Women with Osteoporosis: Results of FACTS1 1 Fosamax Actonel Comparison Trials. -International

机译：阿仑膦酸对骨质疏松症的绝经后妇女的骨密度和周转率产生的影响大于利塞膦酸：FACTS1 1 Fosamax Actonel比较试验的结果。 -国际

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Background: The objective of the study was to evaluate the effects of alendronic acid once weekly relative to risedronic acid once weekly on bone mineral density (BMD), markers of bone turnover and tolerability in the treatment of osteoporosis in postmenopausal women.Methods:This was a randomised, double-masked, double-dummy multicentre international study (75 centres in 27 countries in Europe, the Americas and Asia-Pacific). A total of 1303 women were screened and 936 with low bone density (T-score ≤?2.0 at the spine, hip trochanter, total hip or femoral neck) were randomised; 91% (n = 854) completed the study. Patients were randomised to treatment with either active alendronic acid 70mg weekly (Fosamax?) and placebo identical to risedronic acid weekly or active risedronic acid 35mg weekly (Actonel?) and placebo identical to alendronic acid weekly for 12 months. The primary efficacy endpoint was the percentage change from baseline in hip trochanter BMD at 12 months. Secondary endpoints included the percentage change from baseline in lumbar spine, total hip and femoral neck BMD; biochemical markers of bone turnover (including serum bone-specific alkaline phosphatase [BSAP] and urinary type I collagen N-telopeptides [NTx]); and safety and tolerability as assessed by reporting of adverse experiences.Results: Alendronic acid produced greater increases in BMD than did risedronic acid at 12 months at all sites measured. Mean percentage increases from baseline in hip trochanter BMD at month 12 were 3.56% and 2.71% in the alendronic acid and risedronic acid groups, respectively (treatment difference [95% CI]: 0.83% [0.22, 1.45; p = 0.008]). Mean percentage increases from baseline were greater with alendronic acid than risedronic acid at the lumbar spine, total hip and femoral neck BMD at month 12 (p = 0.002, p < 0.001, p = 0.039, respectively). Increases in BMD with alendronic acid compared with risedronic acid were also significantly greater at 6 months at the trochanter and total hip. There was a greater reduction in bone turnover with alendronic acid compared with risedronic acid: NTx decreased 58% with alendronic acid compared with 47% with risedronic acid at 12 months (p < 0.001); and BSAP decreased 45% with alendronic acid compared with 34% with risedronic acid at 12 months (p < 0.001). Overall tolerability and upper gastrointestinal tolerability were similar for both agents. Conclusions: Alendronic acid once weekly produced greater BMD increases at both hip and spine sites and greater reductions in bone turnover relative to risedronic acid once weekly. Both agents were well tolerated with no significant difference in upper gastrointestinal adverse experiences. Clinicians should consider these results when making treatment decisions for postmenopausal women with osteoporosis.
机译：背景：这项研究的目的是评估相对于瑞斯来膦酸每周一次的阿仑膦酸对绝经后妇女骨质疏松症的骨矿物质密度（BMD），骨转换的标志和耐受性的影响。一项随机，双掩蔽，双虚拟的多中心国际研究（在欧洲，美洲和亚太地区的27个国家中有75个中心）。共有1303名妇女接受了筛查，其中936名低骨密度（脊柱，髋转子，总髋部或股骨颈的T值≤2.0）被随机分配。 91％（n = 854）完成了研究。患者随机接受每周70毫克的活性阿仑膦酸（Fosamax？）和每周一次与利塞膦酸相同的安慰剂或每周35毫克的活性利屈膦酸（Actonel？）和每周与阿仑膦酸相同的安慰剂治疗12个月。主要疗效终点是髋关节转子BMD在12个月时偏离基线的百分比变化。次要终点包括腰椎，总髋部和股骨颈BMD相对于基线的百分比变化;骨转换的生化标志物（包括血清骨特异性碱性磷酸酶[BSAP]和尿I型胶原蛋白N-端肽[NTx]）;结果：在所有测量部位，阿仑膦酸在12个月时产生的BMD升高均高于利塞膦酸。阿仑膦酸组和瑞斯膦酸组在第12个月中，髋关节转子BMD的基线平均增加百分比分别为3.56％和2.71％（治疗差异[95％CI]：0.83％[0.22，1.45; p = 0.008]）。在第12个月时，在腰椎，总髋部和股骨颈BMD上，阿仑膦酸的平均基线增加百分比大于利塞膦酸（分别为p = 0.002，p <0.001，p = 0.039）。在转子和全髋关节，在6个月时，阿仑膦酸BMD的升高与利塞膦酸的升高相比也明显更大。与阿司匹林酸相比，阿仑膦酸的骨转换率有更大的降低：在12个月时，阿仑膦酸的NTx下降58％，比利塞膦酸的47％下降（p <0.001）。在12个月时，阿仑膦酸的BSAP降低了45％，而利塞膦酸的BSAP降低了34％（p <0.001）。两种药物的总体耐受性和上消化道耐受性相似。结论：相对于每周一次利塞膦酸，每周一次的阿仑膦酸在髋部和脊柱部位产生更大的BMD升高，并且骨代谢的减少更大。两种药物均耐受良好，上消化道不良反应无明显差异。在为绝经后骨质疏松症妇女做出治疗决策时，临床医生应考虑这些结果。

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