Emkey Ronald, Delmas Pierre D, Bolognese Michael, Borges Joao Lindolfo C, Cosman Felicia, Ragi-Eis Sergio, Recknor Christopher, Zerbini Cristiano A, Neate Colin, Sedarati Farhad, Epstein Solomon
Radiant Research, Wyomissing, Pennsylvania 19610, USA.
Clin Ther. 2009 Apr;31(4):751-61. doi: 10.1016/j.clinthera.2009.04.018.
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.
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.
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.
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 <or=30% of patients per group during this 1-year study.
The data from these postmenopausal women with osteoporosis suggest that once-monthly 150-mg ibandronate therapy provided clinically comparable efficacy in terms of BMD response, reductions in bone turnover, and GI tolerability similar to that of weekly 70-mg alendronate.
MOTION（每月口服伊班膦酸钠治疗骨质疏松症干预研究）报告称，在12个月内增加腰椎和全髋部骨矿物质密度（BMD）方面，每月一次的伊班膦酸钠不劣于每周一次的阿仑膦酸钠。在对MOTION的次要和探索性终点进行分析时，包括转子和股骨颈BMD，发现每月一次的伊班膦酸钠不劣于每周一次的阿仑膦酸钠。此前已报告了MOTION的共同主要、次要和探索性BMD终点。
本报告展示了MOTION研究的更多结果，包括腰椎和全髋部BMD较基线增加的反应率；骨转换标志物血清浓度比较的结果；以及耐受性分析，包括导致停药的不良事件和胃肠道（GI）不良事件。
MOTION是一项为期12个月（随访15天）的随机、多国、多中心、双盲、双模拟、平行组、非劣效性研究，纳入年龄在55至<85岁的绝经后骨质疏松症女性。患者被随机分配接受每月150毫克口服伊班膦酸钠和每周阿仑膦酸钠匹配的安慰剂，或每周70毫克口服阿仑膦酸钠和每月伊班膦酸钠匹配的安慰剂，为期12个月。在基线、治疗第7天、3个月和6个月、6个月+7天以及12个月时，在全部试验人群的一个子集中测量骨吸收标志物（Ⅰ型胶原α链C末端肽[sCTX]）和骨形成（血清Ⅰ型胶原N末端前肽）的血清浓度。在基线和第12个月时，使用双能X线吸收法测量BMD。还对12个月时脊柱、全髋部和转子BMD高于基线的患者（反应者）进行了探索性分析。
共纳入1760名女性（伊班膦酸钠组887例患者；阿仑膦酸钠组873例）。每月一次伊班膦酸钠治疗时sCTX谷浓度的中位数变化为-75.5%，每周一次阿仑膦酸钠治疗时为-81.2%。伊班膦酸钠组腰椎和全髋部平均BMD较基线增加的患者百分比（反应者）分别为90%和87%，阿仑膦酸钠组分别为92%和90%。在这项为期1年的研究中，每组<或=30%的患者报告了胃肠道不良事件。
这些绝经后骨质疏松症女性的数据表明，每月一次150毫克伊班膦酸钠治疗在BMD反应、骨转换降低以及胃肠道耐受性方面提供了与每周70毫克阿仑膦酸钠临床可比的疗效。
