This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor 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.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000073-45
Application #
7719172
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2008-04-01
Project End
2009-03-31
Budget Start
2008-04-01
Budget End
2009-03-31
Support Year
45
Fiscal Year
2008
Total Cost
$23,847
Indirect Cost
Name
University of Texas Medical Br Galveston
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
800771149
City
Galveston
State
TX
Country
United States
Zip Code
77555
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