Effects of two 1-year calcium and vitamin D-3 treatments on bone remodeling markers and femoral bone density in elderly women

The aim of this study was to compare the effects of a 1-year treatment with calcium and vitamin D-3 combined in a tablet (Orocal(R)) with the effects of a reference treatment of calcium administered in a sachet (Ostram(R)) an d vitamin D-3 as a tablet (Devaron(R)) on bone remodeling markers and bone mineral density (BMD) in elderly women. The study population comprised 119 women greater than or equal to 70 years of age, 80% of whom were institutio nalized. The women were randomly allocated to receive treatment for 1 year with elemental calcium 0.5 g and vitamin D-3 400 IU combined in one chewabl e tablet taken twice daily (group 1) or elemental calcium 0.6 g (1 sachet) and vitamin D-3 400 IU (1 chewable tablet) taken twice daily (group 2), BMD of the proximal femur was measured at four sites before and after the 1-ye ar treatment period; serum 1-84 intact parathyroid hormone (PTH) concentrat ion, serum 25-hydroxyvitamin D-3 (25[OH]D-3) concentration, and bone alkali ne phosphatase activity were measured at baseline and after 6 and 12 months of treatment, At month 12, BMD had increased at all sites in patients in g roup 1; the increase was statistically significant at the trochanter (2.34% ), In group 2, BMD had increased slightly at the femoral neck and decreased slightly at the other sites, without any statistically significant differe nces. BMD changes were not statistically different between the two groups e xcept at the trochanter, where we observed a 2.34% increase in group 1 vers us a 0.32% decrease in group 2. In group 1, PTH decreased significantly fro m baseline to month 6 (13%) and then did not change significantly from mont h 6 to month 12. In group 2 the decrease was not statistically significant; , In addition, 25(OH)D-3 increased significantly in the two groups from bas eline to month 6 (group 1, 107%; group 2, 96%), This significant increase c ontinued but became less marked from month 6 to month 12 (13% and 15%, resp ectively). Bone alkaline phosphatase values decreased significantly in both groups from baseline to month 6; however, this decrease was significantly greater in group 1 (35%) than in group 2 (22%). From month 6 to month 12, v alues remained constant in both groups. In this study, results with the cal cium and vitamin D-3 combination tablet were comparable to those of the sep arated calcium and vitamin D-3 supplementation concerning parameters involv ed in senile osteoporosis. Densitometric data showed some prevention of age -related bone loss; biochemical data showed the correction of vitamin D-3 d eficiency and the reduction of PTH secretion, both of which are responsible for increased bone remodeling in the elderly. The results of this study co nfirm those of previous studies on the effects of calcium and vitamin D-3 s upplementation in institutionalized elderly patients.