Fujii Memorial Institute of Medical Sciences, Tokushima University, Tokushima, 770-8530, Japan.
Laboratory for Autoimmune Diseases, RIKEN Center for Integrative Medical Sciences, Yokohama, Kanagawa, Japan.
J Bone Miner Metab. 2020 Jul;38(4):522-532. doi: 10.1007/s00774-020-01091-4. Epub 2020 Mar 5.
Eldecalcitol increases bone mineral density (BMD) and reduces vertebral fracture in patients with primary osteoporosis. However, the effect of eldecalcitol on BMD and fracture in glucocorticoid-induced osteoporosis (GIO) patients is unknown. This study was undertaken to compare the effect of eldecalcitol on BMD and fracture with that of alfacalcidol in GIO patients.
A randomized, open-label, parallel group study was conducted to identify the effectiveness and safety of monotherapy with 0.75 μg eldecalcitol compared with 1.0 μg alfacalcidol in GIO patients.
Lumbar spine BMD increased with eldecalcitol, but decreased with alfacalcidol at 12 and 24 months (between group difference 1.29%, p < 0.01, and 1.10%, p < 0.05, respectively). Total hip and femoral neck BMD were maintained until 24 months by eldecalcitol, but decreased by alfacalcidol (between group difference 0.97%, p < 0.05 and 1.22%, p < 0.05, respectively). Both bone formation and resorption markers were more strongly suppressed by eldecalcitol than by alfacalcidol. Eldecalcitol showed better effect on BMD than alfacalcidol in patients with no prevalent fracture and BMD > 70% of the young adult mean, and with ≤ 3 months of previous glucocorticoid treatment. No significant difference in the incidence of vertebral fracture was found, and the incidence of adverse events was similar between the two groups.
Eldecalcitol was more effective than alfacalcidol in maintaining BMD in GIO patients. Because eldecalcitol was effective in patients with no or short-term previous glucocorticoid treatment, as well as those without prevalent fracture or low BMD, eldecalcitol can be a good candidate for primary prevention of GIO.
UMIN000011700.
艾地骨化醇可增加原发性骨质疏松症患者的骨密度（BMD）并减少椎体骨折。然而，艾地骨化醇对糖皮质激素诱导性骨质疏松症（GIO）患者的 BMD 和骨折的影响尚不清楚。本研究旨在比较艾地骨化醇与骨化三醇治疗 GIO 患者的疗效和安全性。
采用随机、开放标签、平行组研究，比较 0.75μg 艾地骨化醇与 1.0μg 骨化三醇单药治疗 GIO 患者的有效性和安全性。
艾地骨化醇治疗 12 个月和 24 个月时腰椎 BMD 增加，而骨化三醇治疗 12 个月和 24 个月时腰椎 BMD 降低（组间差异分别为 1.29%，p<0.01 和 1.10%，p<0.05）。艾地骨化醇治疗至 24 个月时总髋部和股骨颈 BMD 保持稳定，而骨化三醇治疗时则降低（组间差异分别为 0.97%，p<0.05 和 1.22%，p<0.05）。与骨化三醇相比，艾地骨化醇更能强烈抑制骨形成和骨吸收标志物。在无骨折既往史且 BMD 高于年轻成人平均值的 70%、且既往糖皮质激素治疗时间≤3 个月的患者中，艾地骨化醇在 BMD 方面的疗效优于骨化三醇。两组患者椎体骨折发生率无显著差异，不良反应发生率相似。
与骨化三醇相比，艾地骨化醇更能有效维持 GIO 患者的 BMD。由于艾地骨化醇对无或短期糖皮质激素治疗史、无骨折既往史或低 BMD 的患者有效，因此它可能是 GIO 一级预防的良好候选药物。
UMIN000011700。
