EFFECT OF HORMONAL CONTRACEPTION ON BONE MINERAL DENSITY

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 最近的研究表明，使用长效醋酸甲羟孕酮（DMPA）可能对骨密度（BMD）产生不良影响。 相比之下，据报道使用口服避孕药有有益效果或没有效果。 在一项初步研究中，我们观察到DMPA使用者的骨密度下降了3.0%，而30-35 ug药丸使用者的骨密度增加了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，几乎没有关于最近销售的仅含20微克雌二醇的药丸的效果的数据。 为了解决这一重要问题，我们建议进行一项前瞻性临床试验，比较使用DMPA或含有20 μ g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2年内BMD的变化。 每个队列将由229名年龄为16 - 33岁的白色、黑人或西班牙裔人种/种族的女性组成。 主要结果（即，将分析BMD和骨代谢生物标志物），以评估相对于基线对照的变化。 此外，我们将能够在停药时和此后6个月内评估激素测量生物标志物的潜在不良反应的可逆性。最终，这项研究将确定哪些女性（如果有的话）由于在生育年龄使用这些激素避孕药而导致骨质减少或骨质疏松症的风险增加。

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 not 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 estradoil. To address this important question, we propose to conduct a prospective clinical trial comparing changes in BMD over a 2-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.