
The difference between the two groups was 2.65% (95% CI =–0.44, 5.75%) with a trend in favor of the active treatment group. In a subgroup of 114 patients, femoral neck bone mineral density (BMD) decreased in the placebo group (mean =–2.36% per year, SD = 4.92), while remaining unchanged in women treated with calcium-vitamin D 3 (mean = 0.29% per year, SD = 8.63). Both types of calcium-vitamin D 3 regimens increased serum 25-hydroxyvitamin D and decreased serum intact parathyroid hormone to a similar extent, with levels returning within the normal range after 6 months. Fixed and separate combination groups received the same daily amount of calcium (1200 mg) and vitamin D 3 (800 IU), which had similar pharmacodynamic effects. The intention-to-treat population consisted of 583 ambulatory institutionalized women (mean age 85.2 years, SD = 7.1) randomized to the calcium–vitamin D 3 fixed combination group ( n= 199) the calcium plus vitamin D 3 separate combination group ( n= 190) and the placebo group ( n= 194). Decalyos II is a 2-year, multicenter, randomized, double-masked, placebo-controlled confirmatory study. Calcium and vitamin D supplements can reverse secondary hyperparathyroidism thus preventing hip fractures, as proved by Decalyos I. Vitamin D insufficiency and low calcium intake contribute to increase parathyroid function and bone fragility in elderly people.
