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 B12) may improve hyperhomocysteinemia.
Objective To investigate whether treatment with folate and vitamin B12 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
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<.001). The number
of hip fractures per 1000 patient-years was 10 and 43 for the treatment and
placebo groups, respectively (P<.001). The adjusted
relative risk, absolute risk reduction, and the number needed to treat for
hip fractures in the treatment vs placebo groups were 0.20 (95% confidence
interval [CI], 0.08-0.50), 7.1% (95% CI, 3.6%-10.8%), and 14 (95% CI, 9-28),
respectively. No significant adverse effects were reported.
Conclusion In this Japanese population with a high baseline fracture risk, combined
treatment with folate and vitamin B12 is safe and effective in
reducing the risk of a hip fracture in elderly patients following stroke.