The effect of oral colchicine and vitamin K1 on bone metabolism in patients with diabetes mellitus: A post-hoc analysis of a 2 × 2 factorial randomized controlled trial with 18F-sodium fluoride positron emission tomography

IF 3.5 2区医学 Q2 ENDOCRINOLOGY & METABOLISM

Bone Pub Date : 2025-04-19 DOI:10.1016/j.bone.2025.117492

Jamie W. Bellinge , Marc Sim , Roslyn J. Francis , Sing Ching Lee , Dick C. Chan , Christian M. Girgis , Gerald F. Watts , Joshua R. Lewis , Carl J. Schultz

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Abstract

Purpose

Diabetes mellitus (DM) confers an increased risk of fracture. Fracture risk stratification techniques are imperfect, and preventative therapies are sparse. We aimed to describe features associated with a dysfunctional bone metabolism determined by ¹⁸F-Sodium Fluoride Positron Emission Tomography (¹⁸F-NaF PET) in patients with DM and test the effects of vitamin K1 and colchicine therapy on vertebral ¹⁸F-NaF activity.

Methods

This is a post-hoc analysis of a 2 × 2 factorial randomized double-blind placebo-controlled trial. Participants aged 50–80 with DM underwent ¹⁸F-NaF PET/CT imaging at baseline, 3 months of therapy with vitamin K1 (10mg/daily) or placebo, and colchicine (0.5 mg/day) or placebo and repeat ¹⁸F-NaF PET/CT. The ¹⁸F-NaF vertebral mean standardized uptake value (SUVmean) and the CT estimated bone mineral density (BMD) (in Hounsfield units) was evaluated from thoracic vertebra.

Results

In total, 149 individuals (66.4 % male, mean age 65.5 ± 6.8 years) were included. Male sex (β −1.421, 95 % CI [−1.826, −1.016], p < 0.001), duration of DM in years (−0.021 [−0.039, −0.002], p = 0.030) and CT estimated vertebral BMD (0.011 [0.006, 0.015], p < 0.001) were independently associated with the SUVmean. The change in the SUVmean was similar between vitamin K1 or placebo groups (−0.07 ± 0.64 v 0.07 ± 0.69, p = 0.20). Participants receiving colchicine therapy had a greater reduction in the SUVmean, compared with placebo (−0.12 ± 0.72 v 0.11 ± 0.60, p = 0.039).

Conclusion

¹⁸F-NaF PET may be a useful measure of vertebral bone metabolism in people with DM. Three months of oral colchicine reduced the ¹⁸F-NaF vertebral SUVmean, whereas Vitamin K1 had no effect. The findings should be considered hypothesis generating.

Trial Registration: www.anzctr.org.au (ACTRN12616000024448).

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口服秋水仙碱和维生素K1对糖尿病患者骨代谢的影响：一项使用18f -氟化钠正电子发射断层扫描的2 × 2因子随机对照试验的事后分析

目的糖尿病（DM）会增加骨折的风险。骨折风险分层技术并不完善，预防性治疗方法也很少。我们的目的是描述与糖尿病患者18f -氟化钠正电子发射断层扫描（18F-NaF PET）确定的骨代谢功能失调相关的特征，并测试维生素K1和秋水仙碱治疗对椎体18F-NaF活性的影响。方法：这是一项2 × 2因子随机双盲安慰剂对照试验的事后分析。年龄在50-80岁的糖尿病患者在基线时接受18F-NaF PET/CT成像，3个月的维生素K1 （10mg/天）或安慰剂治疗，秋水仙碱（0.5 mg/天）或安慰剂治疗，并重复18F-NaF PET/CT。从胸椎评估18F-NaF椎体平均标准化摄取值（SUVmean）和CT估计骨矿物质密度（BMD）（以Hounsfield单位）。结果共纳入149例，其中男性占66.4%，平均年龄65.5±6.8岁。男性(β−1.421,95%可信区间(−1.826−1.016),p & lt;0.001)、糖尿病病程年数（- 0.021 [- 0.039,- 0.002],p = 0.030）和CT估计椎体骨密度(0.011 [0.006,0.015],p <；0.001)与suv均值独立相关。维生素K1组和安慰剂组的SUVmean变化相似（- 0.07±0.64 v 0.07±0.69,p = 0.20）。与安慰剂相比，接受秋水仙碱治疗的受试者的SUVmean降低幅度更大（- 0.12±0.72 v 0.11±0.60,p = 0.039）。结论18F-NaF PET可能是测量DM患者椎体骨代谢的有效指标，口服秋水仙碱3个月可降低18F-NaF椎体SUVmean，而维生素K1无影响。这些发现应该被认为是假设生成的。试验注册：www.anzctr.org.au （ACTRN12616000024448）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Bone 医学-内分泌学与代谢

CiteScore

8.90

自引率

4.90%

发文量

264

审稿时长

30 days

期刊介绍： BONE is an interdisciplinary forum for the rapid publication of original articles and reviews on basic, translational, and clinical aspects of bone and mineral metabolism. The Journal also encourages submissions related to interactions of bone with other organ systems, including cartilage, endocrine, muscle, fat, neural, vascular, gastrointestinal, hematopoietic, and immune systems. Particular attention is placed on the application of experimental studies to clinical practice.