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EFFECT OF HORMONAL CONTRACEPTION ON BONE MINERAL DENSITY

EFFECT OF HORMONAL CONTRACEPTION ON BONE MINERAL DENSITY
激素避孕对骨矿物质密度的影响
批准号:
7719172
负责人:
ABBEY B BERENSON
金额:
$2.38万
依托单位国家:
美国
项目类别:
财政年份:
2008
资助国家:
美国
项目状态:
已结题
起止时间:
2008-04-01 至 2009-03-31

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项目成果

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中文摘要
翻译
这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金, 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 最近的研究表明,使用醋酸甲羟孕酮(DMPA)可能会对骨密度(BMD)产生不利影响。相比之下,口服避孕药的使用据报道有有益的效果或没有效果。在一项初步研究中,我们观察到服用DMPA的人骨密度下降了3.0%,而服用30-35ug药片的人骨密度增加了0.1%-2.9%。然而,关于BMD和DMPA之间的具体关系的问题尚未得到充分解决。此外,几乎没有关于最近上市的只含有20微克雌二醇的药片的效果的数据。为了解决这个重要的问题,我们建议进行一项前瞻性临床试验,比较使用DMPA或含有20微克雌二醇的口服避孕药的妇女与不使用激素避孕药的妇女在3年时间间隔内BMD的变化。每个队列将由229名年龄在16岁至33岁之间的白人、黑人或西班牙裔种族/民族的女性组成。将分析主要结果(即骨密度和骨代谢的生物标志物),以评估与基线对照相比的变化。此外,我们将能够评估激素测量生物标记物在停用点和从这一点起每隔6个月的潜在不良影响的可逆性。最终,这项研究将确定哪些妇女(如果有的话)因在生育年龄使用这些激素避孕药而面临骨量减少或骨质疏松症的风险增加。
英文摘要
This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Recent studies have suggested that use of depot medroxyprogesterone acetate (DMPA) may have an adverse effect on bone mineral density (BMD). In contrast, use of oral contraceptives has been reported to have a beneficial effect or no effect. In a preliminary study, we observed a decrease of 3.0% in BMD among users of DMPA as compared with an increase of 0.1%-2.9% among users of 30-35 ug pills. Questions regarding the specific relationship between BMD and DMPA, however, have not been fully addressed. Furthermore, almost no data are available on the effects of the recently m arketed pills containing only 20 ug of estradiol. To address this important question, we propose to conduct a prospective clinical trial comparing changes in BMD over a 3-year interval experienced by women using DMPA or oral contraceptives containing 20 ug estradiol as compared with women not using hormonal contraception. Each cohort will be comprised of 229 women aged 16 to 33 years of white, black, or Hispanic race/ethnicity. The primary outcomes (i.e., BMD and biomarkers of bone metabolism) will be analyzed to assess changes from baseline controls. Furthermore, we will be able to assess the reversibility of potential adverse effects of hormonal measuring biomarkers at the point of discontinuation and at 6-month intervals from this point. Ultimately, this study will determine which women, if any, are placed at increased risk of osteopenia or osteoporosis as a result of using these hormonal contraceptives during their reproductive years.
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