Iwamoto Jun, Okano Hiroya, Furuya Takefumi, Urano Tomohiko, Hasegawa Masaichi, Hirabayashi Hisashi, Kumakubo Takami, Makita Kazuya
Institute for Integrated Sports Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-Ku, Tokyo, 160-8582, Japan.
Department of Orthopaedic Surgery, Keiyu Orthopaedic Hospital, Gunma, 374-0011, Japan.
J Bone Miner Metab. 2016 Mar;34(2):201-8. doi: 10.1007/s00774-015-0653-7. Epub 2015 Mar 21.
Minodronate is a potent nitrogen-containing bisphosphonate that can be administered according to a monthly (every 4 weeks) dosing regimen. A 6-month, cluster-randomized, open-label, multicenter, crossover trial was conducted to test the preference of Japanese patients with osteoporosis for monthly bisphosphonate versus weekly bisphosphonate. One hundred and forty-seven patients (postmenopausal women and men) with primary osteoporosis were recruited at eight outpatient clinics. The clinics were randomized into two groups according to the dosing protocol-monthly minodronate followed by weekly alendronate or risedronate for a total of 24 weeks, or weekly alendronate or risedronate followed by monthly minodronate for 24 weeks. Patient preference for either the monthly or weekly bisphosphonate regimen was evaluated using a preference questionnaire. One hundred and fifteen patients (78.2 %) who completed the trial were processed for the analyses. Significantly more patients preferred the monthly bisphosphonate regimen (65.2 %) than the weekly bisphosphonate regimen (15.7 %) (P = 0.007). 'Dosing schedule fits lifestyle better' was the most common reason given for the patient preference for both the monthly (32.0 %) and weekly bisphosphonate (33.3 %) regimens. Significantly more patients found the monthly bisphosphonate regimen to be more convenient (73.0 %) than the weekly bisphosphonate regimen (13.9 %) (P < 0.0001). The safety profiles of the two regimens were similar. The present trial demonstrated a strong patient preference for and the convenience of the monthly bisphosphonate regimen over the weekly bisphosphonate regimen in Japanese patients with osteoporosis.
米诺膦酸是一种强效含氮双膦酸盐，可按照每月（每4周）给药方案使用。一项为期6个月的整群随机、开放标签、多中心交叉试验开展，以测试日本骨质疏松症患者对每月一次双膦酸盐与每周一次双膦酸盐的偏好。在8家门诊诊所招募了147例原发性骨质疏松症患者（绝经后女性和男性）。诊所根据给药方案随机分为两组，一组先服用每月一次的米诺膦酸，随后服用每周一次的阿仑膦酸钠或利塞膦酸钠，共24周；另一组先服用每周一次的阿仑膦酸钠或利塞膦酸钠，随后服用每月一次的米诺膦酸，共24周。使用偏好问卷评估患者对每月或每周双膦酸盐方案的偏好。对115例完成试验的患者进行分析。明显更多患者偏好每月一次双膦酸盐方案（65.2%）而非每周一次双膦酸盐方案（15.7%）（P = 0.007）。“给药时间表更符合生活方式”是患者偏好每月一次双膦酸盐方案（32.0%）和每周一次双膦酸盐方案（33.3%）的最常见原因。明显更多患者发现每月一次双膦酸盐方案比每周一次双膦酸盐方案更方便（73.0% 对13.9%）（P < 0.0001）。两种方案的安全性相似。本试验表明，在日本骨质疏松症患者中，患者强烈偏好每月一次双膦酸盐方案，且该方案比每周一次双膦酸盐方案更方便。
