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Sato Y, Honda Y, Iwamoto J, Kanoko T, Satoh K. Effect of Folate and Mecobalamin on Hip Fractures in Patients With
Stroke: A Randomized Controlled Trial. JAMA. 2005;293(9):1082–1088. doi:10.1001/jama.293.9.1082
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.
To investigate whether treatment with folate and vitamin B12
reduces the incidence of hip fractures in patients with hemiplegia following
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
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.
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
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