Orimo H, Shiraki M, Hayashi Y, Hoshino T, Onaya T, Miyazaki S, Kurosawa H, Nakamura T, Ogawa N
Department of Geriatrics, Faculty of Medicine, University of Tokyo, Japan.
Calcif Tissue Int. 1994 May;54(5):370-6. doi: 10.1007/BF00305521.
The effects of 1 alpha-hydroxyvitamin D3 [1 alpha(OH)D3] on bone mineral density, fracture incidence, and bone metabolism were evaluated by a double-blind, placebo-controlled study. Eighty postmenopausal osteoporotic Japanese women (71.9 +/- 7.3 years, mean +/- SD) were randomly assigned to 1 microgram of 1 alpha(OH)D3 daily or inactive placebo for 1 year. All patients were given supplemental calcium (300 mg of elemental calcium daily). Lumbar (L2-L4) bone mineral density (BMD) determined by dual energy X-ray absorptiometry increased 0.65% with 1 alpha(OH)D3 treatment and decreased 1.14% with placebo (P = 0.037). BMD in both the femoral neck and Ward's triangle did not yield any significant differences between the two groups, whereas trochanter BMD in the 1 alpha(OH)D3-treated group increased 4.20% and decreased 2.37% with placebo (P = 0.055). X-ray analysis demonstrated that new vertebral fractures occurred in two patients with 1 alpha(OH)D3 and in seven patients with placebo. The vertebral fracture rate in the treated group was significantly less (75/1000 patient years) than in the control group (277/1000 patient years; P = 0.029). Hypercalcemia (12.1 mg/100 ml) occurred in one patient receiving 1 alpha(OH)D3; however, the serum calcium level in this patient promptly decreased to the reference range after cessation of the treatment. There were no significant changes in serum creatinine level in either group. A significant increase in urinary excretion of calcium was found but there was no significant change in urinary excretion of hydroxyproline in the treated group. The serum level of bone-derived alkaline phosphatase activity significantly decreased by -26 +/- 26 (mU/ml) after the treatment (P = 0.003).(ABSTRACT TRUNCATED AT 250 WORDS)
通过一项双盲、安慰剂对照研究，评估了1α-羟基维生素D3 [1α(OH)D3] 对骨矿物质密度、骨折发生率和骨代谢的影响。80名绝经后骨质疏松的日本女性（平均年龄71.9±7.3岁，均值±标准差）被随机分配，每天服用1μg 1α(OH)D3或无活性安慰剂，为期1年。所有患者均补充钙（每日300mg元素钙）。采用双能X线吸收法测定，1α(OH)D3治疗组腰椎（L2-L4）骨矿物质密度（BMD）增加了0.65%，安慰剂组下降了1.14%（P = 0.037）。两组股骨颈和Ward三角区的BMD无显著差异，而1α(OH)D3治疗组粗隆部BMD增加了4.20%，安慰剂组下降了2.37%（P = 0.055）。X线分析显示，1α(OH)D3组有2例患者出现新的椎体骨折，安慰剂组有7例。治疗组的椎体骨折率（75/1000患者年）显著低于对照组（277/1000患者年；P = 0.029）。1例接受1α(OH)D3治疗的患者出现高钙血症（12.1mg/100ml）；然而，该患者停药后血清钙水平迅速降至参考范围。两组患者的血清肌酐水平均无显著变化。治疗组尿钙排泄量显著增加，但尿羟脯氨酸排泄量无显著变化。治疗后血清骨源性碱性磷酸酶活性水平显著下降-26±26（mU/ml）（P = 0.003）。（摘要截选至250字）
