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NCT00310791 · ClinicalTrials.gov registry record · Phase 2
Adrenal and Gonadal Hormone Replacement in Anorexia Nervosa
A Phase 2 study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT00310791 is a Phase 2 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 80 participants.
The verdict
NCT00310791, a Phase 2 study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study 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).
Interventions
- OTHER Placebo (Sugar Pill)
- DRUG Dehydroepiandrosterone (DHEA)
- DRUG Hormone replacement therapy (estrogen/progestin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2004-04 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00310791
The ClinicalTrials.gov registry entry for NCT00310791 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo (Sugar Pill) is the first listed.
NCT00310791 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00310791 about?
NCT00310791 is a clinical study titled "Adrenal and Gonadal Hormone Replacement in Anorexia Nervosa". 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 ...
What is the current status of trial NCT00310791?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2004-04. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00310791?
The interventions under investigation include: Placebo (Sugar Pill) (OTHER), Dehydroepiandrosterone (DHEA) (DRUG), Hormone replacement therapy (estrogen/progestin) (DRUG).
Who is sponsoring clinical trial NCT00310791?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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