A new active vitamin D, ED-71, increases bone mass in osteoporotic patients under vitamin D supplementation: A randomized, double-blind, placebo-controlled clinical trial
A new active vitamin D, ED-71, increases bone mass in osteoporotic patients under vitamin D supplementation: A randomized, double-blind, placebo-controlled clinical trial
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DOI：
10.1210/jc.2004-2552
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发表时间：
2005-09-01
影响因子：
5.8
通讯作者：
Nakamura, T
中科院分区：
文献类型：
--
作者：
Matsumoto, T;Miki, T;Nakamura, T
背景：艾德- 71已被证明可以增加腰椎骨密度（BMD）在骨质疏松症的受试者。然而，维生素D不足可能会影响艾德- 71对BMD的影响。目的：我们的目的是检查艾德- 71是否可以增加维生素D补充下的骨质疏松患者的BMD。设计，设置和患者：我们进行了一项随机，双盲，安慰剂对照的临床试验，219例骨质疏松患者干预：受试者被随机分配接受安慰剂或0.5、0.75或1.0 μ g/ dED-71，持续12个月。所有受试者均接受200或400 IU/ d维生素D-3。主要结果指标：我们评估了腰部和臀部BMD和骨转换标志物较基线的变化。结果：艾德- 71治疗12个月后腰椎BMD增加（在接受0.5、0.75和1.0 μ g艾德- 71的受试者中，与基线相比分别为2.2、2.6和3.1%，与安慰剂组相比分别为2.9、3.4和3.8%）。0.75和1.0 μ g艾德-71组的全髋BMD也增加（0.5、0.75和1.0 μ g艾德- 71组分别较基线增加0.8、0.6和0.9%，与安慰剂组相比增加0.1、1.5和1.8%）。0.75和1.0 μ g艾德- 71治疗12个月后，骨形成和吸收标记物被抑制约20%。在0.5、0.75和1.0 μ g艾德- 71组中，分别有7%、5%和23%的受试者出现了超过2.6 mmol/L的一过性高钙血症，但没有一个人出现持续性高钙血症。这些结果表明，约0.75 μ g/ml的艾德- 71处理可显著降低细胞凋亡。维生素D能安全有效地增加腰椎和髋部骨密度。
Context: ED- 71 has been shown to increase lumbar bone mineral density ( BMD) in osteoporotic subjects. However, vitamin D insufficiency might have influenced the effect of ED- 71 on BMD.Objective: Our objective was to examine whether ED- 71 can increase BMD in osteoporotic patients under vitamin D supplementation.Design, Setting, and Patients: We conducted a randomized, double- blind, placebo- controlled clinical trial of 219 osteoporotic patients ( 49 - 87 yr of age).Interventions: Subjects were randomly assigned to receive placebo or 0.5, 0.75, or 1.0 mu g/ dED-71 for 12 months. All the subjects received 200 or 400 IU/ d vitamin D-3.Main outcome measures: We assessed changes in lumbar and hip BMD and bone turnover markers from baseline.Results: Lumbar BMD increased with ED- 71 treatment for 12 months ( 2.2, 2.6, and 3.1% from baseline and 2.9, 3.4, and 3.8% vs. placebo group in subjects receiving 0.5, 0.75, and 1.0 mu g ED- 71, respectively). Total hip BMD also increased with 0.75 and 1.0 mu g ED- 71 ( - 0.8, 0.6, and 0.9% from baseline and 0.1, 1.5, and 1.8% vs. placebo group in the 0.5, 0.75, and 1.0 mu g ED- 71 groups, respectively). Bone formation and resorption markers were suppressed by approximately 20% after 12 months of 0.75 and 1.0 mu g ED- 71 treatment. Transient hypercalcemia over 2.6 mmol/ liter occurred in 7, 5, and 23% of subjects in the 0.5, 0.75, and 1.0 mu g ED- 71 groups, respectively, but none of them developed sustained hypercalcemia.Conclusions: These results demonstrate that ED- 71 treatment at around 0.75 mu g/ d can effectively and safely increase lumbar and hip BMD in osteoporotic patients with vitamin D supplementation.