Methods
Trial design and participants
For this explorative study, antidepressant users from the multicenter
B-PROOF (B-Vitamins for the Prevention of Osteoporotic Fractures;
ClinicalTrials.gov NCT00696514) study were included. A detailed
description of the trial was published previously 14.
In short, B-PROOF was a large multicenter, double-blind,
placebo-controlled trial for which persons 65 years and older with
mildly elevated homocysteine levels were recruited to participate
between 2008 and 2011, for a follow-up period of 2-3 years. A total of
2,919 participants were included. The primary aim was to assess whether
the addition of vitamin B12 and folic acid to vitamin D therapy
prevented osteoporotic fractures. Because the intervention did not
affect fall-related outcomes, data could be used for the current
observational study 15. The Medical Ethics Committee
of Wageningen University approved the study protocol of the B-PROOF
study 14. Before entering the study, all participants
gave their written informed consent. All experiments were conducted in
accordance with the principles of the Declaration of Helsinki.