Effect of daily vitamin B-12 and folic acid supplementation on fracture incidence in elderly individuals with an elevated plasma homocysteine concentration: B-PROOF, a randomized controlled trial.

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2919 elderly hyperhomocysteinemic patients at risk for osteoporotic fractures were randomized to receive daily oral supplements containing 500 mg vitamin B-12, 400 mg folic acid and 600 IU of vitamin D3 or a placebo supplement containing only vitamin D3. The purpose of this study was to investigate whether the intake of vitamin B-12 and folic acid impacted the time to first osteoporotic fracture and if adverse events occurred from its consumption. The results indicated that there was no significant difference in the time to first osteoporotic fracture occurrence between the two groups. Compliant patients over 80, however, displayed an improved fracture rate when compared to placebo. It was also noted that but the supplement-receiving group had a greater incidence of cancer development during the course of the trial, however, further studies are needed to evaluate the effect of these supplements on cancer incidence.