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NCT00720122 · ClinicalTrials.gov registry record · Phase 2
Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT00720122: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT00720122 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 28 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00720122, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study Summary
Adolescents and young adults with anorexia nervosa (AN) are at high risk for low bone mineral density at a time when healthy adolescents are rapidly accruing bone, with implications for peak bone mass and fracture risk in later life. They are also deficient in insulin-like growth factor 1 (IGF-1), the bone trophic factor made in the liver in response to growth hormone (GH), despite elevated levels of growth hormone. It is possible that deficiency of insulin-like growth factor 1, a hormone very important for the maintenance of skeletal integrity, may contribute to the severe osteopenia seen in anorexia nervosa. The physiologic effects of recombinant human insulin-like growth factor 1 (rhIGF-1) treatment in adolescents and young adults with anorexia nervosa have not been studied. The goal of this proposal is to investigate the effects of recombinant human insulin-like growth factor 1 on bone density and bone microarchitecture in adolescent girls and young adult women with anorexia nervosa over a 6 month period. We hypothesize that adolescent and young adult anorexia nervosa patients, being insulin-like growth factor 1 deficient, will respond to exogenously administered recombinant human insulin-like growth factor 1 with elevations in biochemical indices of bone turnover and an increase in bone density and improvement in bone structure, or maintain bone density (in contrast to the decrease in bone density expected in adolescent girls and women with anorexia nervosa who are not treated).
Interventions
- DRUG Recombinant human insulin like growth factor-1 (rhIGF-1)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2008-07 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00720122
The ClinicalTrials.gov registry entry for NCT00720122 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Recombinant human insulin like growth factor-1 (rhIGF-1) is the first listed.
NCT00720122 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00720122 about?
NCT00720122 is a clinical study titled "Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa". Adolescents and young adults with anorexia nervosa (AN) are at high risk for low bone mineral density at a time when healthy adolescents are rapidly accruing bone, with implications for peak bone mass and fracture risk in later life. They are also deficient in insulin-like growth factor 1 (IGF-1), t...
What is the current status of trial NCT00720122?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2008-07. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00720122?
The interventions under investigation include: Recombinant human insulin like growth factor-1 (rhIGF-1) (DRUG).
Who is sponsoring clinical trial NCT00720122?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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