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 F-sodium fluoride positron emission tomography.

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 F-Sodium Fluoride Positron Emission Tomography (F-NaF PET) in patients with DM and test the effects of vitamin K1 and colchicine therapy on vertebral F-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 F-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 F-NaF PET/CT. The F-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

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

TRIAL REGISTRATION

www.anzctr.org.au (ACTRN12616000024448).