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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: Completed Phase 2 study, sponsored by Boston Children's Hospital.

NCT00310791 is a Phase 2 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 80 participants
Start Date 2004-04
Est. Completion 2010-12
Phase Phase 2
Boston Children's Hospital

462 total trials

What the finished NCT00310791 record still lists

NCT00310791 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo (Sugar Pill) is the first listed.

NCT00310791 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00310791's enrollment target sits among peer trials

80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00310791, the US trial registry maintained by the National Library of Medicine. NCT00310791 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.