Department of Endocrinology, Peking Union Medical College Hospital, Beijing, China.
Beijing Friendship Hospital Capital Medical University, Beijing, China.
J Bone Miner Metab. 2019 Nov;37(6):1036-1047. doi: 10.1007/s00774-019-01009-9. Epub 2019 May 13.
Eldecalcitol increased bone mineral density (BMD) and prevented vertebral fractures in vitamin D-sufficient osteoporotic subjects. However, the effect of eldecalcitol on BMD under vitamin D insufficiency is unknown. We examined the effect of eldecalcitol on BMD compared with alfacalcidol in osteoporotic patients without vitamin D or calcium supplementation. This is a randomized, double-blind, active comparator trial. 265 Chinese osteoporotic patients were randomly assigned to receive 0.75 μg eldecalcitol or 1.0 μg alfacalcidol for 12 months without vitamin D or calcium supplementation. Baseline calcium intakes were less than 550 mg/day and mean serum 25-hydroxyvitamin D [25(OH)D] was below 43 nmol/L in both groups. Baseline BMD tended to be lower in patients with lower calcium intake and serum 25(OH)D. Lumbar BMD increased by 2.05% higher in eldecalcitol than alfacalcidol group at 12 months. Total hip and femoral neck BMD also increased by 1.33 and 1.78%, respectively, in the eldecalcitol than the alfacalcidol group. The effect of eldecalcitol on BMD was not affected by serum 25(OH)D or calcium intake. The incidence of adverse events was not different between the two groups. Incidence of hypercalcemia in the edecalcitol group was not affected by serum 25(OH)D. In conclusion, baseline BMD tended to be lower in patients with low calcium intake and serum 25(OH)D. Eldecalcitol increased lumbar and hip BMD more than alfacalcidol regardless of serum 25(OH)D or calcium intake without vitamin D or calcium supplementation. These results suggest that eldecalcitol is effective in increasing the BMD of osteoporotic patients regardless of vitamin D status or calcium intake.Clinical Trial Registration number JAPIC CTI 152904.
艾地骨化醇增加了骨密度（BMD）并预防了维生素 D 充足的骨质疏松症患者的椎体骨折。然而，艾地骨化醇对维生素 D 不足患者的 BMD 影响尚不清楚。我们检查了艾地骨化醇与阿尔法骨化醇相比在未补充维生素 D 或钙的骨质疏松症患者中的 BMD 效应。这是一项随机、双盲、阳性对照试验。265 名中国骨质疏松症患者被随机分配接受 0.75μg 艾地骨化醇或 1.0μg 阿尔法骨化醇治疗，为期 12 个月，未补充维生素 D 或钙。两组患者的基线钙摄入量均少于 550mg/天，平均血清 25-羟维生素 D [25(OH)D]低于 43nmol/L。基线 BMD 在钙摄入量和血清 25(OH)D 较低的患者中倾向于较低。12 个月时，艾地骨化醇组腰椎 BMD 增加 2.05%，高于阿尔法骨化醇组。总髋部和股骨颈 BMD 也分别增加了 1.33%和 1.78%，在艾地骨化醇组高于阿尔法骨化醇组。艾地骨化醇对 BMD 的影响不受血清 25(OH)D 或钙摄入量的影响。两组不良反应发生率无差异。艾地骨化醇组高钙血症的发生率不受血清 25(OH)D 的影响。结论：基线 BMD 在钙摄入量和血清 25(OH)D 较低的患者中倾向于较低。艾地骨化醇增加腰椎和髋部 BMD 多于阿尔法骨化醇，无论血清 25(OH)D 或钙摄入量如何，均无需补充维生素 D 或钙。这些结果表明，艾地骨化醇在增加骨质疏松症患者的 BMD 方面是有效的，无论维生素 D 状态或钙摄入量如何。临床试验注册号 JAPIC CTI 152904。
