Adrenal and Gonadal Hormone Replacement in Anorexia Nervosa

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Anorexia Nervosa

In brief

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).

Key facts

Study ID

NCT00310791

Run by

Boston Children's Hospital

People needed

80

Starts

2004-04-01

Expected to finish

2010-12-01

Last updated by the study team

2018-04-11

Who can join

Age: 15 and older, up to 30. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age 15 - 30 years
• Anorexia nervosa by psychiatric criteria
• Amenorrhea for at least 3 months

You may not qualify if…

• Receiving no medications known to affects bone metabolism
• No other chronic medical conditions

Where it is running

• Children's Hospital Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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