Harrington J T, Ste-Marie L-G, Brandi M L, Civitelli R, Fardellone P, Grauer A, Barton I, Boonen S
University of Wisconsin Medical School, Madison, WI, USA.
Calcif Tissue Int. 2004 Feb;74(2):129-35. doi: 10.1007/s00223-003-0042-4. Epub 2003 Dec 5.
Prevention of nonvertebral fractures, which account for a substantial proportion of osteoporotic fractures, is an important goal of osteoporosis treatment. Risedronate, a pyridinyl bisphosphonate, significantly reduces clinical vertebral fracture incidence within 6 months. To determine the effect of risedronate on osteoporosis-related nonvertebral fractures, data from four large, randomized, double-blind, placebo-controlled, Phase III studies were pooled and analyzed. The population analyzed consisted of postmenopausal women, with and without vertebral fractures, who had low bone mineral density (lumbar spine T-score <-2.5). Patients received placebo (N = 608) or risedronate 5 mg daily (N = 564) for 1 to 3 years. At baseline, 58% had at least one prevalent vertebral fracture, and the mean lumbar spine T-score was -3.4. Among placebo-treated patients, the presence of prevalent vertebral fractures did not increase the risk of incident nonvertebral fractures overall, although fractures of the humerus and hip and pelvis were more common in patients who had prevalent vertebral fractures than in those who did not. Risedronate 5 mg significantly reduced the incidence of nonvertebral fractures within 6 months compared with control. After 1 year, nonvertebral fracture incidence was reduced by 74% compared with control ( P = 0.001), and after 3 years, the incidence was reduced by 59% ( P = 0.002). The results indicate that risedronate significantly reduces the incidence of osteoporosis-related nonvertebral fractures within 6 months.
非椎体骨折占骨质疏松性骨折的很大比例,预防非椎体骨折是骨质疏松症治疗的一个重要目标。利塞膦酸盐是一种吡啶基双膦酸盐,可在6个月内显著降低临床椎体骨折发生率。为了确定利塞膦酸盐对骨质疏松症相关非椎体骨折的影响,对四项大型、随机、双盲、安慰剂对照的III期研究数据进行了汇总和分析。分析的人群包括有或无椎体骨折、骨密度低(腰椎T值<-2.5)的绝经后女性。患者接受安慰剂(N = 608)或每日5 mg利塞膦酸盐(N = 564)治疗1至3年。基线时,58%的患者至少有一处椎体骨折,腰椎平均T值为-3.4。在接受安慰剂治疗的患者中,总体上既往椎体骨折的存在并未增加非椎体骨折的发生风险,尽管肱骨、髋部和骨盆骨折在有既往椎体骨折的患者中比没有既往椎体骨折的患者更常见。与对照组相比,5 mg利塞膦酸盐在6个月内显著降低了非椎体骨折的发生率。1年后,与对照组相比,非椎体骨折发生率降低了74%(P = 0.001),3年后,发生率降低了59%(P = 0.002)。结果表明,利塞膦酸盐在6个月内显著降低了骨质疏松症相关非椎体骨折的发生率。