Toda Aska, Sawada Kenjiro, Yoshimura Akihiko, Nakatsuka Erika, Kuroda Hiromasa, Kozasa Katsumi, Miyamoto Mayuko, Hashimoto Kae, Mabuchi Seiji, Kimura Tadashi
Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
Int J Womens Health. 2017 Nov 13;9:821-825. doi: 10.2147/IJWH.S145805. eCollection 2017.
In clinical practice, patients with postmenopausal osteoporosis have often shown a poor response to treatment with an antiresorptive agent for several years. The purpose of this study was to investigate the efficacy of switching raloxifene with minodronate in patients who responded poorly to the treatment of postmenopausal osteoporosis with raloxifene.
This observational study was conducted based on a single-arm, non-randomized, open-label design and was approved by the institute's institutional review board. Postmenopausal women with osteoporosis who became unresponsive in terms of bone mineral density (BMD) after being administered raloxifene for two or more years were enrolled. Patients were treated with 1 mg minodronate daily or 50 mg minodronate monthly. Changes in BMD and serum bone turnover markers were monitored at baseline, 6, 12, and 24 months after switching treatment.
Twenty-seven patients were enrolled. Two discontinued treatment because of adverse events related to the study drug. Among the remaining 25 patients, lumbar BMD significantly increased by 3.67%, 5.08%, and 6.97% at 6, 12, and 24 months, respectively, and femoral neck BMD increased by 1.63%, 2.18%, and 3.85% at 6, 12, and 24 months, respectively. Serum bone-specific alkaline phosphatase showed a significant reduction of 30.35% from the baseline (<0.0001) within the first 6 months, suggesting a stronger antiresorptive effect of minodronate. Serum N-terminal telopeptide of type I collagen showed a tendency to decrease.
Switching raloxifene with minodronate is effective in poor responders of osteoporosis treatment and should be considered as one of the treatment options for osteoporosis.
在临床实践中，绝经后骨质疏松症患者使用抗吸收药物治疗数年往往效果不佳。本研究的目的是调查在对雷洛昔芬治疗绝经后骨质疏松症反应不佳的患者中，将雷洛昔芬换用米诺膦酸的疗效。
本观察性研究采用单臂、非随机、开放标签设计，并获得了该机构机构审查委员会的批准。纳入使用雷洛昔芬治疗两年或更长时间后骨密度（BMD）无反应的绝经后骨质疏松症妇女。患者每日接受1毫克米诺膦酸治疗或每月接受50毫克米诺膦酸治疗。在换药治疗后的基线、6个月、12个月和24个月监测BMD和血清骨转换标志物的变化。
共纳入27例患者。2例因与研究药物相关的不良事件而停药。在其余25例患者中，腰椎BMD在6个月、12个月和24个月时分别显著增加3.67%、5.08%和6.97%，股骨颈BMD在6个月、12个月和24个月时分别增加1.63%、2.18%和3.85%。血清骨特异性碱性磷酸酶在最初6个月内较基线显著降低30.35%（<0.0001），表明米诺膦酸具有更强的抗吸收作用。血清I型胶原N端前肽有下降趋势。
将雷洛昔芬换用米诺膦酸对骨质疏松症治疗反应不佳者有效，应作为骨质疏松症的治疗选择之一。
