Phase 3
N=80
Adrenal and Gonadal Hormone Replacement in Anorexia Nervosa
Anorexia Nervosa
Bottom Line
View on ClinicalTrials.gov: NCT00310791 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Areal Bone Density by DXA — 0.88; 0.89 g/cm2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Hormone replacement therapy (estrogen/progestin) (Drug); Placebo (Sugar Pill) (Other); Dehydroepiandrosterone (DHEA) (Drug)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- Female
- Sponsor
- Boston Children's Hospital
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Areal Bone Density by DXA |
0.88; 0.89 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00310791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.