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首页> 外文期刊>Journal of bone and mineral research: the official journal of the American Society for Bone and Mineral Research >Oral daily ibandronate prevents bone loss in early postmenopausal women without osteoporosis.
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Oral daily ibandronate prevents bone loss in early postmenopausal women without osteoporosis.

机译:每天口服伊班膦酸可预防绝经后早期无骨质疏松症的妇女的骨质流失。

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摘要

Oral daily ibandronate was investigated for the prevention of bone loss in postmenopausal women without osteoporosis (n = 653). BMD at the lumbar spine and hip were significantly increased (3.1% and 1.8%, respectively; p < or = 0.0001 versus placebo) with 2.5 mg ibandronate after 24 months. Oral ibandronate is a promising option for the prevention of postmenopausal bone loss. INTRODUCTION: Further strategies to manage patients most at risk from developing postmenopausal osteoporosis are required. The objectives of this multicenter, double-blind, randomized, placebo-controlled study were to examine the efficacy, tolerability, and optimal dose of oral daily ibandronate in the prevention of bone loss in postmenopausal women. MATERIALS AND METHODS: In total, 653 women (mean bone mineral density [BMD] T-score > -2.5 at the lumbar spine), who had been postmenopausal for at least 1 year, were allocated to one of four strata based on time since menopause and baseline lumbar spine BMD. Women were randomized to receive calcium (500 mg daily) plus either placebo (n = 162) or ibandronate 0.5 mg (n = 162), 1 mg (n = 166), or 2.5 mg (n = 163) as once-daily oral treatment for 2 years. The primary endpoint was the mean percent change in lumbar spine BMD with ibandronate versus placebo. RESULTS AND CONCLUSIONS: After 2 years, oral daily ibandronate produced a dose-related and sustained maintenance or increase in BMD at the lumbar spine and hip (total hip, femoral neck, trochanter), together with a dose-related reduction in the rate of bone turnover. The greatest nominal increases in spinal and hip BMD were observed with the 2.5-mg dose, which produced statistically significant BMD gains compared with placebo at 6 months and all subsequent time-points at the spine and hip (3.1% and 1.8% increase in lumbar spine and total hip BMD, respectively, versus placebo; p < or = 0.0001 after 24 months). Oral daily ibandronate was well tolerated with an incidence of upper gastrointestinal adverse events similar to placebo. No safety concerns were identified. In summary, oral daily ibandronate 2.5 mg decreases bone turnover, preserves or increases BMD in the spine and proximal femur, and is well tolerated. Oral ibandronate provides a promising option for the prevention of bone loss in postmenopausal women.
机译:每天口服伊班膦酸用于预防无骨质疏松的绝经后妇女的骨质流失(n = 653)。服用2.5毫克伊班膦酸24个月后,腰椎和髋部的BMD显着增加(分别为3.1%和1.8%;与安慰剂相比p <或= 0.0001)。口服伊班膦酸盐是预防绝经后骨质流失的有前途的选择。简介:需要进一步的策略来管理绝经后骨质疏松症风险最高的患者。这项多中心,双盲,随机,安慰剂对照研究的目的是检查口服每日伊班膦酸预防绝经后妇女骨质流失的功效,耐受性和最佳剂量。材料与方法:绝经后至少1年的653名女性(腰椎平均骨矿物质密度[BMD] T分数> -2.5)被分配到四个阶层之一更年期和腰椎基线BMD。女性被随机分配为每日一次口服钙(每日500 mg)加安慰剂(n = 162)或伊班膦酸0.5 mg(n = 162),1 mg(n = 166)或2.5 mg(n = 163)治疗2年。主要终点是伊班膦酸与安慰剂相比腰椎骨密度变化的平均百分比。结果与结论:2年后,每天口服伊班膦酸在腰椎和髋部(全髋,股骨颈,转子)产生剂量相关的持续BMD维持或增加,并且剂量相关的降低率骨转换。 2.5 mg剂量可观察到脊柱和髋部BMD的最大名义增幅,与安慰剂相比,在6个月及以后的所有时间点,脊柱和髋部均产生了统计学上显着的BMD增高(腰椎分别增加3.1%和1.8%脊柱和全髋BMD与安慰剂相比; 24个月后p <或= 0.0001)。口服伊班膦酸耐受性良好,与安慰剂相似,有上消化道不良事件的发生。没有发现安全隐患。总之,每天口服2.5毫克伊班膦酸盐可降低骨转换,保留或增加脊柱和股骨近端的BMD,并且耐受性良好。口服伊班膦酸盐为预防绝经后妇女的骨质流失提供了一个有前途的选择。

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