Action of 1,25-dihydroxyvitamin D₃ on calcium balance and bone turnover and its effect on vertebral fracture rate

In postmenopausal osteoporotics, malabsorption of calcium is associated with reduced levels of serum 1,25-dihydroxyvitamin D. Metabolic studies have shown that calcium absorption can be normalized and calcium balance improved after administration of oral doses of synthetic 1,25-dihydroxyvitamin D₃ (Rocaltrol^®) 0.25 μg twice daily. Further studies performed at two centers compared the effect of Rocaltrol^® 0.25 μg twice daily versus placebo on vertebral fracture rates in osteoporotics. A significant reduction in vertebral fracture rates was seen at the end of 1 year. Those patients who continued on Rocaltrol^® for a second and third year showed a progressive decrease in vertebral fractures. Rocaltrol^®, administered at a dose of 0.25 μg twice daily, seldom causes hypercalcuria or hypercalcemia in osteoporotic patients on a typical calcium intake of 700 to 800 mg/d. Careful measurements of renal function over a period of 3 years in patients treated with Rocaltrol^®, 0.25 μg twice daily, showed no deterioration in renal function. These data suggest that 1,25-dihydroxyvitamin D₃ is a useful therapy in the management of patients with postmenopausal osteoporosis, particularly those who have malabsorption of calcium. We found that it improves calcium balance, reduces the vertebral fracture rate, and is safe to use provided that the dietary calcium is monitored and does not exceed 800 mg/d.