Effect of Folate and Mecobalamin on Hip Fractures in Patients With Stroke: A Randomized Controlled Trial

TLDR: Combined treatment with folate and vitamin B12 is safe and effective in reducing the risk of a hip fracture in elderly patients following stroke in this Japanese population with a high baseline fracture risk.

Abstract: Context Stroke increases the risk of subsequent hip fracture by 2 to 4 times. Hyperhomocysteinemia is a risk factor for both ischemic stroke and osteoporotic fractures in elderly men and women. Treatment with folate and mecobalamin (vitamin B 12 ) may improve hyperhomocysteinemia. Objective To investigate whether treatment with folate and vitamin B 12 reduces the incidence of hip fractures in patients with hemiplegia following stroke. Design, Setting, and Patients A double-blind, randomized controlled study of 628 consecutive patients aged 65 years or older with residual hemiplegia at least 1 year following first ischemic stroke, who were recruited from a single Japanese hospital from April 1, 2000, to May 31, 2001. Patients were assigned to daily oral treatment with 5 mg of folate and 1500 μg of mecobalamin, or double placebo; 559 completed the 2-year follow-up. Main Outcome Measure Incidence of hip fractures in the 2 patient groups during the 2-year follow-up. Results At baseline, patients in both groups had high levels of plasma homocysteine and low levels of serum cobalamin and serum folate. After 2 years, plasma homocysteine levels decreased by 38% in the treatment group and increased by 31% in the placebo group ( P P Conclusion In this Japanese population with a high baseline fracture risk, combined treatment with folate and vitamin B 12 is safe and effective in reducing the risk of a hip fracture in elderly patients following stroke.