骨化二醇和胆钙化醇对绝经后女性肌肉功能的影响：一项随机对照试验。
Effect of calcifediol and cholecalciferol on muscle function in postmenopausal women: a randomized controlled trial.
作者信息
Bischoff-Ferrari Heike A, Dawson-Hughes Bess, Orav John E, Ceglia Lisa, Egli Andreas, Kistler-Fischbacher Melanie, Wieczorek Maud, de Godoi Rezende Costa Molino Caroline
机构信息
Department of Geriatrics and Aging Research, University of Zurich, Tièchestrasse 99, 8037, Zurich, Switzerland.
Centre on Aging and Mobility, University of Zurich, Zurich, Switzerland.
出版信息
Osteoporos Int. 2025 Apr 9. doi: 10.1007/s00198-025-07456-7.
UNLABELLED
Brief rationale: Limited evidence exists on calcifediol's effect on lower extremity function in postmenopausal women with osteoporosis or osteopenia.
MAIN RESULT
Calcifediol (20 µg/day) showed no greater benefit than vitamin D3 (3200 IU/day) or placebo. Significance of the paper: Findings do not support high-dose vitamin D3 or calcifediol for improving lower extremity function.
PURPOSE
To test the effect of 20 µg/day of calcifediol compared with 3200 IU/day of vitamin D3 and placebo on lower extremity function in postmenopausal women with osteopenia or osteoporosis.
METHODS
This is a 3-arm double-blind RCT among postmenopausal women aged 50-70 years with serum 25(OH)D < 30 ng/mL, and a DXA-based diagnosis of osteopenia or osteoporosis. Participants were randomized to receive either daily 20 µg calcifediol, daily 3200 IU vitamin D3, or placebo. The primary endpoint was a composite measure of lower extremity function, assessed at baseline, 3, and 6 months, including four tests: gait speed, knee flexor and extensor strength, and repeated sit-to-stand test. The primary endpoint was the probability of success (improvement or maintenance from baseline) in any of the eight tests, four tests at 3 months and four tests at 6 months.
RESULTS
The trial enrolled 152 women (mean age, 61.0 years; mean serum 25(OH)D level, 23.4 ng/mL), and all but one woman completed all follow-up visits. Baseline characteristics, including the four tests of lower extremity function, were balanced across the three groups. The adjusted probability of success in any of the eight tests was 53.6% (95% confidence interval 47%, 60%) with calcifediol, 55.5% (50%, 61%) with vitamin D3, and 61.4% (55%, 67%) with placebo, without significant differences between treatment groups.
CONCLUSIONS
Our findings do not support supplementation with daily calcifediol or equivalent high-dose daily vitamin D3 for improving or maintaining lower extremity function among younger postmenopausal women (age 50-70) with osteopenia or osteoporosis, who were pre-selected for vitamin D insufficiency or deficiency (25(OH)D < 30 ng/mL; baseline mean 25(OH)D 23.4 ng/mL).
TRIAL REGISTRATION
Clinicaltrials.gov; NCT02527668; https://clinicaltrials.gov/ct2/show/NCT02527668.
未标记
简要理由：关于骨化二醇对患有骨质疏松症或骨质减少症的绝经后女性下肢功能的影响，现有证据有限。
主要结果
骨化二醇（20μg/天）并不比维生素D3（3200IU/天）或安慰剂更具益处。论文的意义：研究结果不支持使用高剂量维生素D3或骨化二醇来改善下肢功能。
目的
测试每天20μg骨化二醇与每天3200IU维生素D3及安慰剂相比，对患有骨质减少症或骨质疏松症的绝经后女性下肢功能的影响。
方法
这是一项针对年龄在50 - 70岁、血清25(OH)D＜30ng/mL且经双能X线吸收法诊断为骨质减少症或骨质疏松症的绝经后女性的三臂双盲随机对照试验。参与者被随机分配接受每日20μg骨化二醇、每日3200IU维生素D3或安慰剂。主要终点是下肢功能的综合测量指标，在基线、3个月和6个月时进行评估，包括四项测试：步速、膝关节屈伸力量以及重复坐立试验。主要终点是八项测试中任何一项成功（较基线改善或维持）的概率，3个月时有四项测试，6个月时有四项测试。
结果
该试验招募了152名女性（平均年龄61.0岁；平均血清25(OH)D水平23.4ng/mL），除一名女性外，所有女性均完成了所有随访。包括四项下肢功能测试在内的基线特征在三组间是平衡的。骨化二醇组八项测试中任何一项成功的校正概率为53.6%（95%置信区间47%，60%），维生素D3组为55.5%（50%，61%），安慰剂组为61.4%（55%，67%），各治疗组之间无显著差异。
结论
我们的研究结果不支持对预先选择存在维生素D不足或缺乏（25(OH)D＜30ng/mL；基线平均25(OH)D 23.4ng/mL）的年轻绝经后女性（年龄50 - 70岁）补充每日骨化二醇或等效高剂量每日维生素D3来改善或维持下肢功能。
试验注册
Clinicaltrials.gov；NCT02527668；https://clinicaltrials.gov/ct2/show/NCT02527668 。
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