Effects of 2 Years' Treatment of Osteoporosis with 1 a-Hydroxy Vitamin D3 on Bone Mineral Density and Incidence of Fracture: A Placebo-Controlled, Double-Blind Prospective Study.

Abstract

Abstract.A two-year double-blind study monitored and evaluated the effects of 1a-hydroxy vitamin D3(1a(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 jig/day of 1a(OH)D3 (n=57) or a placebo (n=56) with calcium supplementation in both groups. L2~BMD increased 1.81% and 2.32% after one and 2 years in the 1a(OH)D3group, 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 1a(OH)D3 group (Odd's ratio=0.343, 95% confidence range; 0.0648-1.815).There were no serious adverse effects of the 1a(OH)D3 treatment.It was concluded that two-year treatment with 1a(OH)D3 increased the lumbar BMD and inhibited the decrease in TBBMD. Altough it was not significant, new fracture occurrence in the 1a(OH)D3 group was around 1 /3 of that in the control group.

A Placebo-Controlled, Single-Blind Study to Determine the Appropriate Alendronate Dosage in Postmenopausal Japanese Patients with Osteoporosis.

“…Prior to data analysis, the bone density measurement data were examined for reliability by the Bone Mass Assessment Committee, generally according to the method reported previously [5].…”

“…In Japan, several preparations such as active vitamin D3 analogues [4,5], calcitonin [6], vitamin K2 [7], ipriflavone [8], etidronate [9] and estrogen derivative [10] have been approved for the treatment of osteoporosis because these drugs increase the bone mass of patients with osteoporosis. Of these preparations, etidronate, a derivative of bisphosphonate, has been reported to be a potent inhibitor of bone resorption [11].…”

Treatment of established osteoporosis: a systematic review and cost-utility analysis

“…63,64,[117][118][119][120][121][122][123] These trials included those in which patients in both the intervention and control groups received calcium and/or vitamin D in comparable doses. Those studies in which vitamin D derivatives were compared with another active intervention are discussed later (page 36).…”

“…64,118,120,123 In three studies, vertebral fracture was a secondary outcome measure 63,119,133 and in two, in which vertebral fracture was included as an outcome measure, there was no apparent differentiation between primary and secondary outcome measures. 117,121 Non-vertebral fractures were a secondary outcome measure in three studies, 63,122,123 and were mentioned in a further study that did not appear to differentiate between primary and secondary outcome measures. 121 In only five studies were effects on vertebral fractures reported as the numbers of patients in each arm sustaining fractures.…”

“…121 In only five studies were effects on vertebral fractures reported as the numbers of patients in each arm sustaining fractures. 117,119,[121][122][123] In three trials, non-vertebral fractures were reported in terms of the numbers of patients in each arm sustaining such fractures. 117,122,123 In a further study, only the aggregated figures for vertebral and non-vertebral fractures were reported.…”