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: 7605378
• 负责人: ABBEY B BERENSON
• 金额: $ 10.59万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605378
• 关键词: Address; Adverse effects; Biological Markers; Bone Density; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Contraceptive Agents; Data; Estradiol; Ethnic Origin; Funding; Grant; Hispanics; Hormonal; Institution; Measures; Medroxyprogesterone 17-Acetate; Oral Contraceptives; Osteoporosis; Outcome; Race; Reporting; Research; Research Personnel; Resources; Risk; Source; United States National Institutes of Health; Woman; aged; bone metabolism; cohort; experience; hormonal contraception; pill; prospective; reproductive; trial comparing

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它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) 可能会对骨矿物质密度 (BMD) 产生不利影响。 相比之下，据报道使用口服避孕药有有益作用或无作用。 在一项初步研究中，我们观察到 DMPA 使用者的 BMD 下降了 3.0%，而 30-35 ug 药丸使用者的 BMD 则增加了 0.1%-2.9%。 然而，有关 BMD 和 DMPA 之间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仅含有20微克雌二醇的药丸的效果的数据。 为了解决这个重要问题，我们建议进行一项前瞻性临床试验，比较使用 DMPA 或含有 20 ug 雌二醇的口服避孕药的女性与不使用激素避孕药的女性在 2 年时间间隔内经历的 BMD 变化。 每个队列将由 229 名年龄在 16 至 33 岁之间的白人、黑人或西班牙裔女性组成。 将分析主要结果（即 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以及从此时起每隔 6 个月评估激素测量生物标志物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）由于在育龄期使用这些激素避孕药而面临骨质减少或骨质疏松症风险增加。