Nitrates Do Not Affect Bone Density or Bone Turnover in Postmenopausal Women: A Randomized Controlled Trial

ABSTRACTOrganic nitrates have been reported to have significant effects on bone mineral density (BMD) and bone turnover in previous clinical trials. However, results are inconsistent and some trials with strikingly positive results have been retracted because of scientific misconduct. As preparation for a potential fracture prevention study, we set out to determine the lowest effective dose and the most effective and acceptable nitrate preparation. We undertook a 1 ‐year, double‐blind, randomized, placebo‐controlled trial of three different nitrate preparations and two different doses in osteopenic postmenopausal women, with a planned 1‐year observational extension. The primary endpoint was change in BMD at the lumbar spine, and secondary endpoints inc luded BMD changes at other sites, changes in bone turnover markers, and adverse events. A total of 240 eligible women who tolerated low‐dose oral nitrate treatment in a 2‐week run‐in period were randomized to five different treatment groups or placebo. Over 12 months, there were no statistic ally significant between‐group differences in changes in BMD at any site and no consistent differences in bone turnover markers. When the active treatment groups were pooled, there were also no differences in changes in BMD or bone turnover markers between nitrate treatment and placebo. Eighty‐e ight (27%) women withdrew during the run‐in phase, with the majority because of nitrate‐induced headache, and 41 of 200 (21...
Source: Journal of Bone and Mineral Research - Category: Orthopaedics Authors: Tags: Clinical Trial Source Type: research