The proposed clinical study will test the hypothesis that 12 months of DHEA therapy will increase bone mineral density, as well as increase markers of bone formation and decrease markers of bone resorption in young women with anorexia nervosa. The investigators will examine whether augmenting the low adrenal androgen DHEA level back to the level seen in young adults will increase bone formation and decrease bone resorption, trends reflected in the pilot data, thereby attenuating the bone loss associated with this disease. A double-blinded, randomized controlled trial will include two treatment arms of 30 patients each. Group 1 will receive daily doses of 50mg of DHEA while group 2 will receive a standard regimen of estrogen cycled with progesterone. According to data obtained in the pilot study, a dose of 50mg restores DHEA levels to a range characteristic of the second decade of life. Bone mineral density and bone composition will be measured at baseline and after completion of the study, by dual x-ray absorptiometry (DEXA). The determination of body compostition will permit the investigators to assess the effects of DHEA on fat and lean body mass. Fasting bloods will be obtained to follow other laboratory parameters, although no signs of toxicity were noted (physical or biochemical) during the pilot study. Levels of specific circulating hormones will also be monitored. Determination of the effects of DHEA on markers of bone formation and on indices of bone resorption will be made. Measurement of parameters of bone turnover will provide data as to the effects of DHEA and other androgens on bone formation and resorption. This model will address the longitudinal effects of DHEA on markers of bone turnover and to determine whether restoring the DHEA levels of young women with anorexia nervosa to the normal range of early adulthood will be beneficial in the prevention of bone loss. The investigators anticipate that these studies will enable them to evaluate the efficacy of oral DHEA as a treatment strategy to optimize peak bone mass and to prevent development of osteoporosis in patients with eating disorders.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR002172-17S2
Application #
6265634
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
17
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Children's Hospital Boston
Department
Type
DUNS #
076593722
City
Boston
State
MA
Country
United States
Zip Code
02115
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