Effects of 2 years' treatment of osteoporosis with 1 alpha-hydroxy vitamin D3 on bone mineral density and incidence of fracture: A placebo-controlled, double-blind prospective study

A two-year double-blind study monitored and evaluated the effects of Icc-hydroxy vitamin D-3 (Icr(OH)D-3) on the lumbar (L(2-4)BMD) and total body bone mineral densities (TBBMD) and occurrence of fracture in 113 female osteoporotic patients receiving 0.75 mu g/day of 1 alpha(OH)D-3 (n=57) or a placebo (n=56) with calcium supplementation in both groups. L(2-4)BMD increased 1.81% and 2.32% after one and 2 years in the 1 alpha(OH)D-3 group, but decreased 1.89% (P<0.05) and 0.28% in the placebo group. A significant difference (P<0.01) existed between the two groups after one year. TBBMD decreased significantly in the placebo group by 3.34% (P<0.01) and 3.52% after one and 2 years. Six new fractures occurred in the control group, but only two in the la(OH)D, group (Odd's ratio=0.343, 95% confidence range; 0.0648-1.815). There were no serious adverse effects of the 1 alpha(OH)D-3 treatment. It was concluded that two-year treatment with 1 alpha(OH)D-3 increased the lumbar BMD and inhibited the decrease in TBBMD. Altough it was not significant, new fracture occurrence in the 1 alpha(OH)D-3 group was around 1/3 of that in the control group.