drugset / Trial / NCT00310791

Adrenal and Gonadal Hormone Replacement in Anorexia Nervosa

NCT00310791

RandomizedParallel-groupTriple-blindTreatment

Summary

This study seeks to gain new information on why young women with anorexia nervosa are predisposed to early bone loss and osteoporosis. Through a randomized treatment trial in which participants will receive either combined therapy with the adrenal hormone, dehydroepiandrosterone (DHEA) and estrogen replacement therapy or placebo, we will determine the effects of an 18-month treatment course on bone mass, circulating markers of bone turnover, and serum levels of a factor, insulin-like growth factor I (IGF-I). We are also studying if these therapies change bone structure to increase skeletal strength compared to placebo, as assessed through cross-sectional geometric analysis of our bone density data by dual-energy x-ray absorptiometry (DXA).

Timeline

Start
2004-04
Primary completion
2009-10
Completion
2010-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Dehydroepiandrosterone Other / unclassified 50 mg Oral
Subject Levonorgestrel Small molecule 0.1 mg Oral
Subject conjugated estrogens Other / unclassified 0.3 mg
Subject ethinyl estradiol Small molecule 20 mg Oral

Indications