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Randomized Clinical Trial of Homocysteine Level–Lowering Therapy and Fractures

Anna M. Sawka, MD, PhD, FRCPC; Joel G. Ray, MD, MSc, FRCPC; Qilong Yi, PhD; Robert G. Josse, MBBS, FRCP; Eva Lonn, MD, MSc, FRCPC
Arch Intern Med. 2007;167(19):2136-2139. doi:10.1001/archinte.167.19.2136.
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Hyperhomocysteinemia is associated with an increased risk of skeletal fractures.15 For example, in a prospective cohort study of 2406 individuals from the Netherlands, the associated relative risk of fracture was 1.4 per 1-SD increase in plasma homocysteine.1 In a US prospective study of 825 men and 1174 women, the highest quartile of plasma homocysteine concentration was associated with nearly a 4 times higher risk of hip fracture in men and 1.9 times higher risk in women compared with the lowest quartile.3 Little is known about the effect of lowering homocysteine levels on the risk of clinical fractures. We evaluated the effect of combined treatment with folic acid, pyridoxine hydrochloride (also known as vitamin B6), and cyanocobalamin (also known as vitamin B12) on the risk of clinical fractures in a randomized placebo-controlled trial.

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Cumulative probability of skeletal fracture following homocysteine-lowering therapy compared with placebo.

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