Overview

Adrenal and Gonadal Hormone Replacement in Anorexia Nervosa

Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
Female
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).
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boston Children's Hospital
Boston Children’s Hospital
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
United States Department of Defense
Treatments:
Dehydroepiandrosterone
Estradiol
Estrogens
Estrogens, Conjugated (USP)
Ethinyl Estradiol
Hormones
Levonorgestrel
Progestins
Criteria
Inclusion Criteria:

- Age 15 - 30 years

- Anorexia nervosa by psychiatric criteria

- Amenorrhea for at least 3 months

Exclusion Criteria:

- Receiving no medications known to affects bone metabolism

- No other chronic medical conditions