Oregon Osteoporosis Center, 5050 NE Hoyt, Suite 626, Portland, OR 97213, USA.
Osteoporos Int. 2013 Jan;24(1):301-10. doi: 10.1007/s00198-012-2175-7. Epub 2012 Oct 19.
Bone mineral density response to once weekly delayed-release formulation of risedronate, given before or following breakfast, was non-inferior to that seen with traditional immediate-release risedronate given daily before breakfast. Delayed-release risedronate is a convenient dosing regimen for oral bisphosphonate therapy that might avoid poor compliance.
This 2-year, randomized, controlled, non-inferiority study assessed the efficacy and safety of a delayed-release (DR) 35-mg weekly oral formulation of risedronate that allows subjects to take their weekly risedronate dose before or immediately after breakfast. Results from the first year of the study were published previously (McClung et al. Osteoporos Int 23(1):267-276, 2012); we now report the final results after 2 years.
Women with postmenopausal osteoporosis were randomly assigned to receive risedronate 5 mg immediate-release (IR) daily (n = 307) at least 30 min before breakfast, or risedronate 35 mg DR weekly, either immediately following breakfast (FB, n = 307) or at least 30 min before breakfast (BB, n = 308). Bone mineral density (BMD), bone turnover markers (BTMs), fractures, adverse events, and bone histomorphometry were evaluated.
A total of 248 subjects (80.8 %) in the IR daily group, 234 subjects (76.2 %) in the DR FB weekly group, and 240 subjects (77.9 %) in the DR BB weekly group completed the 2-year study. After 2 years of treatment, BMD increases at the lumbar spine and total hip with the weekly DR doses similar to or greater than that with the IR daily dose. Decreases in BTMs were similar or significantly lower in the DR groups. Bone histomorphometry results did not differ among the DR weekly and the IR daily formulations. The three regimens were similarly well tolerated.
Risedronate 35 mg DR weekly is as effective and as well tolerated as risedronate 5 mg IR daily, and will allow subjects to take their weekly risedronate dose immediately after breakfast.
评估一种每周一次、延迟释放（DR）的 35mg 口服利塞膦酸钠制剂的疗效和安全性，该制剂允许患者在早餐前或早餐后即刻服用每周剂量的利塞膦酸钠。先前已经发表了该研究第一年的结果（McClung 等人，Osteoporos Int 23（1）：267-276，2012 年）；我们现在报告了 2 年后的最终结果。
绝经后骨质疏松症患者被随机分配接受利塞膦酸钠 5mg 每日一次（IR）（n=307），至少在早餐前 30 分钟服用，或利塞膦酸钠 35mg DR 每周一次，在早餐后即刻（FB，n=307）或至少在早餐前 30 分钟（BB，n=308）服用。评估骨密度（BMD）、骨转换标志物（BTMs）、骨折、不良事件和骨组织形态计量学。
IR 每日组共有 248 名（80.8%）、DR FB 每周组 234 名（76.2%）和 DR BB 每周组 240 名（77.9%）患者完成了 2 年的研究。治疗 2 年后，每周 DR 剂量的腰椎和全髋骨密度增加与 IR 每日剂量相似或更大。DR 组的 BTM 下降相似或明显低于 IR 组。DR 每周和 IR 每日制剂之间的骨组织形态计量学结果没有差异。三种方案均具有相似的耐受性。
每周一次、延迟释放的 35mg 利塞膦酸钠与每日一次的 5mg 利塞膦酸钠 IR 一样有效且耐受性良好，并且可以使患者在早餐后立即服用每周剂量的利塞膦酸钠。
