Effects of vitamin D3, omega-3 s and a simple home exercise program on incident vertebral fractures: the DO-HEALTH randomized controlled trial.

Vertebral fractures (VF) are among the most common osteoporotic fractures. The effect of vitamin D3, omega-3 s or a simple home exercise program (SHEP) on VF is unclear. We examined whether vitamin D3, omega-3 s, or SHEP, alone or in combination, over three years, reduce the incidence rate of VF among European older adults. DO-HEALTH is a multi-center, 2 × 2 × 2 factorial design, randomized controlled trial, which included older adults (≥70 yr) free from major health events in the five years prior to enrollment. The study interventions were vitamin D3 (2000IU/d), omega-3 s (1 g/d), and SHEP (3 × 30 min/wk), applied alone or in combination. Quantitative and qualitative VF assessment was determined from lateral thoracolumbar DXA scans. The primary outcome for this analysis was the incidence rate (IR) of total VF, defined as the number of any new and progressed VF over the three-year follow-up. Sensitivity analyses were conducted for only new VF and only VF progressions. Negative binomial regression models were fit, adjusted for age, sex, prior fall, BMI, study site and participant's follow-up time. 1488 participants (mean age 74.9 yr; 77% had low bone mass or osteoporosis; 43.8% had 25(OH)D levels <20 ng/mL) were included. There were 93 incident VF, of which 58 were new VF and 35 were progressions. None of the three treatments reduced the IR of total VF overall, however, the IR was reduced with SHEP compared to the control exercise program in women (IR ratio 0.52, 95% CI 0.28, 0.98). In the sensitivity analysis for VF progressions, SHEP reduced the IR (IR ratio 0.34, 95% CI 0.16, 0.75). Among generally healthy older adults, vitamin D3 and omega-3 s supplementation did not reduce the incidence rate of VF. SHEP reduced the incidence rate of total VF in women and of VF progressions overall. Exercise may play a role in the prevention of VF.