口服避孕药（诺孕酯/炔雌醇）对下丘脑性闭经和骨质减少女性骨密度的影响：一项双盲、安慰剂对照研究的开放标签扩展研究

Effects of an oral contraceptive (norgestimate/ethinyl estradiol) on bone mineral density in women with hypothalamic amenorrhea and osteopenia: an open-label extension of a double-blind, placebo-controlled study.

作者信息

Warren Michelle P, Miller K K, Olson W H, Grinspoon S K, Friedman A J

机构信息

Columbia University, College of Physicians and Surgeons, Department of Obstetrics and Gynecology, PH 16-128, New York, NY 10032, USA.

出版信息

Contraception. 2005 Sep;72(3):206-11. doi: 10.1016/j.contraception.2005.03.007.

DOI:10.1016/j.contraception.2005.03.007

PMID:16102557

Abstract

OBJECTIVE

The effects of long-term triphasic oral contraceptive administration on bone mineral density (BMD) were investigated in premenopausal women with hypothalamic amenorrhea (HA) and osteopenia.

METHODS

After completing three 28-day cycles in the double-blind phase of a placebo-controlled trial, women (mean age, 26.7 years) who received norgestimate 180-250 microg/ethinyl estradiol 35 microg (NGM/EE, n = 15) or placebo (n = 12) in the double-blind phase were to receive open-label NGM/EE for 10 additional cycles.

RESULTS

For subjects completing > or =10 NGM/EE treatment cycles, mean posteroanterior total lumbar spine BMD (L1-L4) increased from 0.881+/-0.0624 g/cm2 at baseline (last visit prior to NGM/EE) to 0.894+/-0.0654 g/cm2 at final visit (p = .043); no significant changes in hip BMD occurred. Decreases in N-telopeptide, osteocalcin, procollagen type I propeptide and bone-specific alkaline phosphatase levels indicated effects on bone metabolism.

CONCLUSIONS

Long-term administration of triphasic NGM/EE to osteopenic women with HA may increase total lumbar spine BMD.

摘要

目的

研究长期服用三相口服避孕药对下丘脑性闭经（HA）和骨质减少的绝经前女性骨矿物质密度（BMD）的影响。

方法

在一项安慰剂对照试验的双盲阶段完成三个28天周期后，双盲阶段接受诺孕酯180 - 250微克/炔雌醇35微克（NGM/EE，n = 15）或安慰剂（n = 12）的女性（平均年龄26.7岁）将接受开放标签的NGM/EE额外10个周期的治疗。

结果

对于完成≥10个NGM/EE治疗周期的受试者，腰椎前后位总骨密度（L1 - L4）从基线时（NGM/EE治疗前的最后一次访视）的0.881±0.0624克/平方厘米增加到末次访视时的0.894±0.0654克/平方厘米（p = 0.043）；髋部骨密度无显著变化。N - 端肽、骨钙素、I型前胶原肽和骨特异性碱性磷酸酶水平降低表明对骨代谢有影响。