Risedronate reverses bone loss in postmenopausal women with low bone mass: results from a multinational, double-blind, placebo-controlled trial. BMD-MN Study Group.
Risedronate reverses bone loss in postmenopausal women with low bone mass: results from a multinational, double-blind, placebo-controlled trial. BMD-MN Study Group.
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利塞膦酸盐可逆转骨量低的绝经后妇女的骨质流失：一项多国、双盲、安慰剂对照试验的结果。
DOI：
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发表时间：
2000
影响因子：
5.8
通讯作者：
J. Reginster
中科院分区：
文献类型：
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作者：
I. Fogelman;C. Ribot;Roger Smith;D. Ethgen;Earl Sod;J. Reginster
我们的目的是研究利塞膦酸钠治疗绝经后低骨量妇女的疗效和耐受性。平均腰椎T评分为-2或更低的妇女（n = 543）接受24个月的安慰剂或利塞膦酸钠（2.5或5 mg/天）。所有患者均接受钙治疗（1 g/天）。主要结果指标为腰椎、股骨颈和股骨转子的骨密度（BMD）。24个月时，5 mg利塞膦酸钠组腰椎BMD较基线增加4%，2.5 mg利塞膦酸钠组增加1.4%，而安慰剂组无变化。在绝经后5年和5年以上的妇女中疗效相似。在24个月时，利塞膦酸钠（5毫克）也增加了股骨颈和转子的BMD，而安慰剂组的BMD下降。仅在治疗6个月后，利塞膦酸钠（5 mg）在所有三个部位均观察到BMD增加。利塞膦酸钠耐受性良好;上消化道不良事件与安慰剂相似。我们的结论是，利塞膦酸钠（5毫克）增加骨密度迅速，有效，是很好的耐受性低骨量绝经后妇女，无论绝经后的时间。
Our objective was to investigate the efficacy and tolerability of risedronate in postmenopausal women with low bone mass. Women with a mean lumbar spine T-score of -2 or less (n = 543) received 24 months of placebo or risedronate (2.5 or 5 mg/day). All received calcium (1 g/day). The principal outcome measures were bone mineral density (BMD) at the lumbar spine, femoral neck, and femoral trochanter. At 24 months, lumbar spine BMD increased from baseline by 4% with 5 mg risedronate and 1.4% in the 2.5-mg group, compared with no change with placebo. Efficacy was similar in women who were less than 5 yr and more than 5 yr postmenopausal. At 24 months, risedronate (5 mg) had also increased BMD at the femoral neck and trochanter, whereas BMD decreased in the placebo group. BMD increases were seen at all three sites with risedronate (5 mg) after only 6 months of therapy. Risedronate was well tolerated; upper gastrointestinal adverse events were similar to placebo. We conclude that risedronate (5 mg) increases BMD rapidly and effectively and is well tolerated in postmenopausal women with low bone mass, regardless of time since menopause.