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两种骨化二醇补充方案对老年髋部骨折术后患者的疗效:一项临床试验

Efficacy of two calcifediol supplementation regimens in older adults post-hip fracture surgery. A clinical trial.

作者信息

Cuadra-Llopart Leonor, Salvà Casanovas Antoni, Cerdà Mas Georgina, Jovell-Fernández Esther

机构信息

Geriatric Department, Consorci Sanitari de Terrassa, Terrassa, Barcelona, Spain.

Department of Medicine, School of Medicine and Health Sciences, Universitat Internacional de Catalunya, Sant Cugat del Vallés, Barcelona, Spain.

出版信息

Eur Geriatr Med. 2025 Sep 15. doi: 10.1007/s41999-025-01303-y.

Abstract

BACKGROUND

Vitamin D deficiency is highly prevalent among older adults with hip fracture and may compromise recovery. This study evaluated the effectiveness of two calcifediol supplementation regimens in correcting serum 25-hydroxyvitamin D [25(OH)D] levels and supporting functional recovery.

METHODS

In this randomized clinical trial, 50 patients aged ≥ 75 years with hip fracture and serum 25(OH)D < 30 ng/mL were assigned to receive calcifediol 266 μg daily for 5 days (intervention group, IG) or 266 μg weekly for 5 weeks (control group, CG). Primary endpoints were the proportion achieving 25(OH)D > 30 ng/mL, change in parathyroid hormone, and functional recovery assessed at discharge and at 3, 6, and 12 months post-fracture.

RESULTS

The mean age was 86 years; 64% were women. Baseline 25(OH)D was 13.3 ng/mL in the IG and 12.0 ng/mL in the CG. After one month, both groups showed increased concentrations (38.2 vs. 35.2 ng/mL; p = 0.50). PTH decreased more in the IG (43.5 vs. 75.2 pg/mL; p = 0.001). Approximately 50% of patients showed clinically meaningful functional improvement. Multivariate analysis indicated lower relative functional gain in CG participants who did not achieve optimal 25(OH)D levels (67.2 vs. 43.7; p = 0.06). No significant differences in long-term functional outcomes were observed between groups.

CONCLUSIONS

Both daily and weekly calcifediol regimens effectively corrected vitamin D deficiency in older adults with hip fracture. Functional improvement at discharge was observed in both groups and was clinically relevant.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03213886 (Date of registration: 11/07/2017).

摘要

背景

维生素D缺乏在髋部骨折的老年人中非常普遍,可能会影响康复。本研究评估了两种骨化二醇补充方案在纠正血清25-羟基维生素D[25(OH)D]水平和促进功能恢复方面的有效性。

方法

在这项随机临床试验中,50名年龄≥75岁、髋部骨折且血清25(OH)D<30 ng/mL的患者被分配接受每日266μg骨化二醇,持续5天(干预组,IG)或每周266μg,持续5周(对照组,CG)。主要终点是血清25(OH)D>30 ng/mL的患者比例、甲状旁腺激素的变化,以及在出院时和骨折后3、6和12个月评估的功能恢复情况。

结果

平均年龄为86岁;64%为女性。干预组的基线25(OH)D为13.3 ng/mL,对照组为12.0 ng/mL。1个月后,两组的浓度均升高(38.2对35.2 ng/mL;p = 0.50)。干预组甲状旁腺激素下降更多(43.5对75.2 pg/mL;p = 0.001)。约50%的患者显示出具有临床意义的功能改善。多变量分析表明,未达到最佳25(OH)D水平的对照组参与者的相对功能增益较低(67.2对43.7;p = 0.06)。两组之间未观察到长期功能结局的显著差异。

结论

每日和每周骨化二醇方案均能有效纠正髋部骨折老年人的维生素D缺乏。两组在出院时均观察到功能改善,且具有临床相关性。

试验注册

ClinicalTrials.gov标识符:NCT03213886(注册日期:2017年7月11日)。

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