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 1 alpha-hydroxy vitamin D3 (1 alpha(OH)D3) on the lumbar (L2-4BMD) and total body bone mineral densities (TBBMD) and occurrence of fracture in 113 female osteoporotic patients receiving 0.75 micrograms/day of 1 alpha(OH)D3 (n = 57) or a placebo (n = 56) with calcium supplementation in both groups. L2-4BMD increased 1.81.% and 2.32% after one and 2 years in the 1 alpha (OH)D3 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 1 alpha(OH)D3 group (Odd's ratio = 0.343, 95% confidence range; 0.0648-1.815). There were no serious adverse effects of the 1 alpha(OH)D3 treatment. It was concluded that two-year treatment with 1 alpha(OH)D3 increased the lumbar BMD and inhibited the decrease in TBBMD. Although it was not significant, new fracture occurrence in the 1 alpha(OH)D3 group was around 1/3 of that in the control group.
Shikari
M
M
Department of Laboratory Medicine, Tokyo Metropolitan Geriatric Hospital, Japan.
Kushida
K
K
Yamazaki
K
K
Nagai
T
T
Inoue
T
T
Orimo
H
H
D000469:Alkaline Phosphatase / Q000097:blood; D015519:Bone Density; D001842:Bone and Bones / Q000293:injuries*; D002118:Calcium / Q000097:blood / Q000652:urine; D004311:Double-Blind Method; D005260:Female; D050723:Fractures, Bone / Q000517:prevention & control*; D006801:Humans; D006887:Hydroxycholecalciferols / Q000627:therapeutic use*; D008159:Lumbar Vertebrae / Q000293:injuries; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy*; D010281:Parathyroid Hormone / Q000097:blood; D010919:Placebos; D011446:Prospective Studies
D006887:Hydroxycholecalciferols; D010281:Parathyroid Hormone; D010919:Placebos; D000469:Alkaline Phosphatase; D002118:Calcium; C008088:alfacalcidol