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首页> 外文期刊>Clinical therapeutics >Efficacy and tolerability of once-monthly oral ibandronate (150 mg) and once-weekly oral alendronate (70 mg): additional results from the Monthly Oral Therapy With Ibandronate For Osteoporosis Intervention (MOTION) study.
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Efficacy and tolerability of once-monthly oral ibandronate (150 mg) and once-weekly oral alendronate (70 mg): additional results from the Monthly Oral Therapy With Ibandronate For Osteoporosis Intervention (MOTION) study.

机译:每月一次口服伊班膦酸(150 mg)和每周一次口服阿仑膦酸盐(70 mg)的疗效和耐受性:伊班膦酸每月口服治疗骨质疏松症的干预措施(MOTION)的其他结果。

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摘要

BACKGROUND: The MOTION (Monthly Oral Therapy with Ibandronate for Osteoporosis Intervention) study reported that once-monthly ibandronate was noninferior to once-weekly alendronate in terms of increasing bone mineral density (BMD) at the lumbar spine and total hip over 12 months. On analysis of secondary and exploratory end points in MOTION, which included trochanter and femoral neck BMD, monthly ibandronate was found to be noninferior to weekly alendronate. The coprimary, secondary, and exploratory BMD end points from MOTION have been previously reported. OBJECTIVE: This report presents additional results from the MOTION study, including response rates in terms of lumbar spine and total hip BMD gains above baseline; findings from a comparison of serum concentrations of bone turnover markers; and tolerability analysis, including adverse events that led to withdrawal and gastrointestinal (GI) adverse events. METHODS: MOTION was a 12-month (with 15-day follow-up), randomized, multinational, multicenter, double-blind, double-dummy, parallel-group, noninferiority study in postmenopausal women aged 55 to <85 years with osteoporosis. Patients were randomly assigned to receive 150-mg-monthly oral ibandronate and weekly alendronate-matched placebo, or 70-mg-weekly oral alendronate and monthly ibandronate-matched placebo, for 12 months. At baseline, day 7 of treatment, 3 and 6 months, 6 months + 7 days, and 12 months, serum concentrations of markers of bone resorption (C-telopeptide of the a chain of type 1 collagen [sCTX]) and bone formation (serum N-terminal propeptides of type 1 collagen) were measured in a subset of the total trial population. At baseline and month 12, BMD was measured using dual-energy x-ray absorptiometry. Exploratory analyses of patients whose spine, total hip, and trochanter BMD at 12 months were above baseline (responders) were also performed. RESULTS: A total of 1760 women were enrolled (ibandronate, 887 patients; alendronate, 873). The median changes in the trough concentrations of sCTX were -75.5% with monthly ibandronate and -81.2% with weekly alendronate. The percentage of patients with mean lumbar spine and total hip BMD gains above baseline (responders) were 90% and 87%, respectively, for ibandronate and 92% and 90%, respectively, for alendronate. GI adverse events were reported in
机译:背景:MOTION(每月用伊班膦酸口服治疗骨质疏松症)研究报告,就腰椎和整个臀部超过12个月的骨矿物质密度(BMD)增加而言,伊班膦酸每月一次不逊于每周一次阿仑膦酸。通过分析MOTION的次要和探索性终点(包括转子和股骨颈BMD),发现伊班膦酸月度次于每周阿仑膦酸盐次。先前已经报道过MOTION的主要,次要和探索性BMD终点。目的:本报告提供了MOTION研究的其他结果,包括腰椎和总基线BMD增高的缓解率。骨转换标志物血清浓度比较的发现;和耐受性分析,包括导致停药的不良事件和胃肠道(GI)不良事件。方法:MOTION是一项针对55岁至85岁以下骨质疏松症的绝经后妇女进行的为期12个月(为期15天的随访),随机,跨国,多中心,双盲,双假,平行组,非劣效性研究。患者被随机分配接受每月150 mg口服伊班膦酸和每周阿仑膦酸盐匹配的安慰剂,或每周70 mg口服阿仑膦酸盐和每月伊贝膦酸盐匹配的安慰剂,为期12个月。在治疗的第7天,3和6个月,6个月+ 7天和12个月的基线,血清中骨吸收标志物(1型胶原蛋白a链[sCTX]的C端肽)的浓度和骨形成(在总试验人群中测量了1型胶原蛋白的N末端前肽)。在基线和第12个月,使用双能X射线吸收法测量BMD。还对12个月时脊柱,全髋和转子BMD高于基线的患者进行了分析(响应者)。结果:总共招募了1760名妇女(伊班膦酸887例;阿仑膦酸873例)。依班膦酸盐每月sCTX谷浓度的中位数变化为-75.5%,每周阿仑膦酸盐为-81.2%。依班膦酸盐平均腰椎和总髋部BMD高于基线水平(响应者)的患者百分比分别为90%和87%,阿仑膦酸盐分别为92%和90%。在这项为期1年的研究中,每组患者中≤30%的患者报告了胃肠道不良事件。结论:这些绝经后骨质疏松妇女的数据表明,每月一次150 mg的伊班膦酸盐治疗在BMD反应,骨转换减少和胃肠道耐受性方面与每周70 mg阿仑膦酸盐相似,在临床上具有可比的疗效。

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