Ilter E, Karalok H, Tufekci E C, Batur O
Department of Gynecology and Obstetrics, Maltepe University Faculty of Medicine, Istanbul, Turkey.
Climacteric. 2006 Apr;9(2):129-34. doi: 10.1080/13697130600652180.
Risedronate is a bisphosphonate used in the treatment of osteoporosis. It has a strong effect in inhibiting osteoclast activity. The primary objective of this study was to evaluate the effectiveness and adverse events of two different forms of risedronate (5 mg and 35 mg) using a rapid biochemical marker for comparison of C-terminal telopeptide (CTx) type I collagen cross-links.
The study was designed at Bakirkoy Dr. Sadi Konuk Education & Research Hospital, between January and June 2004. A total of 123 postmenopausal osteoporotic women were randomly assigned in blocks of three to one of the following groups: control, risedronate 5 mg/day and risedronate 35 mg once a week.
Of the 123 women enrolled, 103 (83.7%) completed the study. Adverse events were experienced by 53.6% in the control group, 56% in the risedronate 5 mg/day group and 53.6% in the group receiving risedronate 35 mg once per week. The most common adverse events were gastrointestinal (21.9% of subjects in group 1, 29.2% of subjects in group 2, 24.3% of subjects in group 3). The women in groups receiving risedronate either 5 mg/day and 35 mg once per week had similarly decreased levels of CTx but the control group was not as effective.
The results support the hypothesis that risedronate 35 mg given once per week has the same therapeutic efficacy and safety as a daily 5 mg regimen. Taking the medicine once a week is likely to be easier and more satisfactory than the daily regimen. However, patients taking a once-a-week regimen may forget to take it due to the 7-day break without medicine.
利塞膦酸盐是一种用于治疗骨质疏松症的双膦酸盐。它在抑制破骨细胞活性方面有很强的作用。本研究的主要目的是使用一种快速生化标志物（I型胶原交联C末端肽，CTx）来评估两种不同形式的利塞膦酸盐（5毫克和35毫克）的有效性和不良事件。
该研究于2004年1月至6月在巴基尔科伊萨迪·科努克博士教育与研究医院进行设计。总共123名绝经后骨质疏松症女性被按每组三人的区组随机分配到以下组之一：对照组、每日服用5毫克利塞膦酸盐组和每周服用一次35毫克利塞膦酸盐组。
在纳入的123名女性中，103名（83.7%）完成了研究。对照组有53.6%的人经历了不良事件，每日服用5毫克利塞膦酸盐组为56%，每周服用一次35毫克利塞膦酸盐组为53.6%。最常见的不良事件是胃肠道反应（第1组中21.9%的受试者、第2组中29.2%的受试者、第3组中24.3%的受试者）。每日服用5毫克和每周服用一次35毫克利塞膦酸盐组的女性CTx水平同样降低，但对照组效果不佳。
结果支持以下假设，即每周服用一次35毫克利塞膦酸盐与每日服用5毫克的治疗方案具有相同的疗效和安全性。每周服用一次药物可能比每日服用方案更容易且更令人满意。然而，采用每周一次方案的患者可能会因7天无药间隔而忘记服药。
