Calcitriol treatment is not effective in postmenopausal osteoporosis.
Calcitriol treatment is not effective in postmenopausal osteoporosis.
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DOI：
10.7326/0003-4819-110-4-267
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发表时间：
1989-02
影响因子：
39.2
通讯作者：
S. Ott;C. Chesnut
中科院分区：
文献类型：
--
作者：
S. Ott;C. Chesnut
研究目的确定骨化三醇是否是治疗绝经后骨质疏松症的有效药物。设计2年随机双盲临床试验。设置大学医学中心与患者招募的媒体公告。患者：86名绝经后椎体压缩性骨折女性。干预患者接受骨化三醇或安慰剂治疗。平均剂量为0.43微克/天。膳食钙为1000 mg/d（24.9 mmol/d）。针对高钙尿症或高钙血症调整药物剂量和膳食钙。测量和主要结果在安慰剂组和对照组之间没有观察到身体总钙百分比变化的显著差异（0.4% +/- 1.0对比0.0% +/- 0.9），单光子吸收法（-0.5% +/- 1.2对比-3.1% +/- 0.9）或双光子吸收法（0.0% +/- 1.7对比-1.0% +/- 2.2）。在安慰剂组和骨化三醇组中分别有16%和26%的患者出现新骨折，因此骨折百分比的差异为10%（95% CI，-5.7%至25.7%）。两组的骨活检均未显示变化。骨化三醇组的血清和尿钙值显著高于安慰剂组，但肾功能并不比安慰剂组差。结论：骨化三醇不是治疗绝经后骨质疏松症的有效药物。
STUDY OBJECTIVE To determine if calcitriol is an effective treatment in postmenopausal osteoporosis. DESIGN Double-blind, randomized clinical trial of 2 years' duration. SETTING University medical center with patients recruited by media announcements. PATIENTS Eighty-six postmenopausal women with vertebral compression fractures. INTERVENTIONS Patients were treated with calcitriol or placebo. Mean dose was 0.43 micrograms/d. Dietary calcium was 1000 mg/d (24.9 mmol/d). The medication dose and dietary calcium were adjusted for hypercalciuria or hypercalcemia. MEASUREMENTS AND MAIN RESULTS No significant differences between placebo and control groups were seen in the percent change in total body calcium (0.4% +/- 1.0 compared with 0.0% +/- 0.9), single photon absorptiometry (-0.5% +/- 1.2 compared with -3.1% +/- 0.9) or dual photon absorptiometry (0.0% +/- 1.7 compared with -1.0% +/- 2.2). New fractures were seen in 16% of the placebo group and 26% of the calcitriol groups, so the difference in percent fractures was 10% (95% CI, -5.7% to 25.7%). Bone biopsies did not show changes in either group. The calcitriol group had significantly higher serum and urine calcium values, but renal function was not worse than in the placebo group. CONCLUSIONS Calcitriol is not an effective treatment for established postmenopausal osteoporosis.