Gallagher J C, Goldgar D
Bone Metabolism Unit, Creighton University Medical Center, Omaha, NE 68131.
Ann Intern Med. 1990 Nov 1;113(9):649-55. doi: 10.7326/0003-4819-113-9-649.
To study the efficacy of synthetic 1,25 dihydroxyvitamin D3 (calcitriol) in the treatment of osteoporosis.
Two-year, double-blind, randomized clinical trial.
University medical center.
Fifty postmenopausal women with vertebral fractures recruited by referral.
Calcium intake was adjusted to 25 mmol/d (1000 mg/d) at baseline. Patients were then randomized to treatment with either calcitriol or placebo. During the study, calcium intake was reduced to 15 mmol/d (600 mg/d) and the dose of calcitriol was adjusted to maintain serum calcium less than 2.74 mmol/L (less than 11.0 mg/dL) or urine calcium less than 9.96 mmol/d (less than 400 mg/d).
After 2 years, the mean dose of calcitriol in the treated group was 0.62 micrograms/d. Bone mineral density of the spine increased 1.94% with calcitriol therapy and decreased 3.92% with placebo (P = 0.001). Total body calcium increased 0.21% with calcitriol therapy and decreased 1.85% with placebo (P = 0.004). Patients receiving placebo had significant decreases in spine density (P = 0.0007) and total body calcium (P = 0.0004). There were no differences in vertebral fracture rates between the groups. Renal function studies were not statistically different between the groups after 2 years.
The treatment of postmenopausal osteoporotic women with synthetic calcitriol for 2 years was associated with increases in spine density and total body calcium. No adverse effects on renal function were seen after long-term calcitriol therapy.
研究合成的1,25 - 二羟维生素D3（骨化三醇）治疗骨质疏松症的疗效。
为期两年的双盲随机临床试验。
大学医学中心。
通过转诊招募的50名患有椎体骨折的绝经后女性。
基线时将钙摄入量调整为25 mmol/d（1000 mg/d）。然后将患者随机分为接受骨化三醇或安慰剂治疗组。在研究期间，将钙摄入量降至15 mmol/d（600 mg/d），并调整骨化三醇剂量以维持血清钙低于2.74 mmol/L（低于11.0 mg/dL）或尿钙低于9.96 mmol/d（低于400 mg/d）。
2年后，治疗组骨化三醇的平均剂量为0.62微克/天。骨化三醇治疗使脊柱骨密度增加1.94%，安慰剂治疗使其降低3.92%（P = 0.001）。骨化三醇治疗使全身钙含量增加0.21%，安慰剂治疗使其降低1.85%（P = 0.004）。接受安慰剂治疗的患者脊柱密度（P = 0.0007）和全身钙含量（P = 0.0004）显著下降。两组之间椎体骨折率无差异。2年后两组间肾功能研究无统计学差异。
用合成骨化三醇治疗绝经后骨质疏松症女性2年与脊柱密度和全身钙含量增加相关。长期骨化三醇治疗后未见对肾功能有不良影响。
