National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan.
J Bone Miner Metab. 2013 Jul;31(4):417-22. doi: 10.1007/s00774-012-0418-5. Epub 2013 Apr 11.
Eldecalcitol, a vitamin D3 analogue, significantly reduces the risk of new vertebral fractures and increases bone mineral density (BMD) more than does alfacalcidol. To determine the effect of eldecalcitol on the incidence of all fragility fractures caused by osteoporosis, we conducted post hoc analyses of the phase III clinical trial to evaluate the incidence of the osteoporotic fractures defined in the World Health Organization (WHO) Technical Report, and, also, the incidence of the major osteoporotic fractures utilized in the WHO Fracture Risk Assessment Tool (FRAX), and compared those in the eldecalcitol group with those in the alfacalcidol group. We also analyzed the incidence of osteoporotic fractures stratified by prespecified risk factors for fractures. Eldecalcitol treatment reduced the incidence of osteoporotic fractures defined by the WHO more than alfacalcidol treatment (18.6 % vs. 25.2 %; hazard ratio, 0.70; 95 % CI, 0.54-0.93). Prevalent vertebral fractures, two or more prevalent vertebral fractures, and total hip BMD T score less than -2.5 were the risk factors for new osteoporotic fractures with significant differences between the two treatments. Eldecalcitol also decreased the incidence of major osteoporotic fractures in the FRAX more than alfacalcidol (11.1 % vs. 16.3 %; hazard ratio, 0.66; 95 % CI, 0.46-0.94). In conclusion, treatment with eldecalcitol reduced the risk of fragility fractures caused by osteoporosis compared with alfacalcidol administration, which may result from a potent effect of eldecalcitol on BMD, bone structure, and bone turnover.
艾地骨化醇是一种维生素 D3 类似物,与骨化三醇相比,能显著降低新发椎体骨折风险并增加骨密度(BMD)。为了确定艾地骨化醇对骨质疏松症引起的所有脆性骨折的发生率的影响,我们对 III 期临床试验进行了事后分析,以评估世界卫生组织(WHO)技术报告中定义的骨质疏松性骨折的发生率,以及 WHO 骨折风险评估工具(FRAX)中使用的主要骨质疏松性骨折的发生率,并将艾地骨化醇组与骨化三醇组进行比较。我们还分析了按骨折的特定危险因素分层的骨质疏松性骨折的发生率。艾地骨化醇治疗降低了 WHO 定义的骨质疏松性骨折的发生率,高于骨化三醇治疗(18.6%比 25.2%;风险比,0.70;95%CI,0.54-0.93)。先前存在的椎体骨折、两个或更多先前存在的椎体骨折以及总髋 BMD T 评分小于-2.5 是新的骨质疏松性骨折的危险因素,两种治疗方法之间存在显著差异。与骨化三醇相比,艾地骨化醇还降低了 FRAX 中主要骨质疏松性骨折的发生率(11.1%比 16.3%;风险比,0.66;95%CI,0.46-0.94)。总之,与骨化三醇治疗相比,艾地骨化醇治疗可降低骨质疏松性骨折的风险,这可能是由于艾地骨化醇对 BMD、骨结构和骨转换具有强大的作用。