Calcium‐ and Vitamin D3‐Fortified Milk Reduces Bone Loss at Clinically Relevant Skeletal Sites in Older Men: A 2‐Year Randomized Controlled Trial

In this 2‐year randomized controlled study of 167 men >50 years of age, supplementation with calcium‐vitamin D3‐fortified milk providing an additional 1000 mg of calcium and 800 IU of vitamin D3 per day was effective for suppressing PTH and stopping or slowing bone loss at several clinically important skeletal sites at risk for fracture. Introduction: Low dietary calcium and inadequate vitamin D stores have long been implicated in age‐related bone loss and osteoporosis. The aim of this study was to assess the effects of calcium and vitamin D3 fortified milk on BMD in community living men >50 years of age. Materials and Methods: This was a 2‐year randomized controlled study in which 167 men (mean age ± SD, 61.9 ± 7.7 years) were assigned to receive either 400 ml/day of reduced fat (∼1%) ultra‐high temperature (UHT) milk containing 1000 mg of calcium plus 800 IU of vitamin D3 or to a control group receiving no additional milk. Primary endpoints were changes in BMD, serum 25(OH)D, and PTH. Results: One hundred forty‐nine men completed the study. Baseline characteristics between the groups were not different; mean dietary calcium and serum 25(OH)D levels were 941 ± 387 mg/day and 77 ± 23 nM, respectively. After 2 years, the mean percent change in BMD was 0.9‐1.6% less in the milk supplementation compared with control group at the femoral neck, total hip, and ultradistal radius (range, p < 0.08 to p < 0.001 after adjusting for covariates). There was a greater increase in lumbar spine BMD in the milk supplementation group after 12 and 18 months (0.8‐1.0%, p ≤ 0.05), but the between‐group difference was not significant after 2 years (0.7%; 95% CI, −0.3, 1.7). Serum 25(OH)D increased and PTH decreased in the milk supplementation relative to control group after the first year (31% and −18%, respectively; both p < 0.001), and these differences remained after 2 years. Body weight remained unchanged in both groups at the completion of the study. Conclusions: Supplementing the diet of men >50 years of age with reduced‐fat calcium‐ and vitamin D3‐enriched milk may represent a simple, nutritionally sound and cost‐effective strategy to reduce age‐related bone loss at several skeletal sites at risk for fracture in the elderly.