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Sponsored by: |
Massachusetts General Hospital |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00720122 |
Adolescents 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 GH. It is possible that deficiency of IGF-1, a hormone very important for the maintenance of skeletal integrity, may contribute to the severe osteopenia seen in AN. The physiologic effects of rhIGF-1 treatment in adolescents with AN have not been studied. The goal of this proposal is to investigate the effects of rhIGF-1 on bone density and bone microarchitecture in adolescent girls with AN over a 6 month period. We hypothesize that adolescent AN patients, being IGF-1 deficient, will respond to exogenously administered rhIGF-1 with elevations in biochemical indices of bone turnover and an increase in bone density and improvement in bone structure.
Condition | Intervention | Phase |
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Bone Density |
Drug: rhIGF-1 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa |
Estimated Enrollment: | 12 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: rhIGF-1
Twice daily sc
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Ages Eligible for Study: | 12 Years to 25 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Melissa Russell, MD | 6177261428 | mrussell@partners.org |
Contact: Madhu Misra, MD | 6177245602 | mmisra@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Madhu Misra, MD 617-724-5602 mmisra@partners.org |
Principal Investigator: | Madhusmita Misra, MD | MD |
Responsible Party: | Mass General Hospital ( Neuroendorcrine Unit Adolescent Study ) |
Study ID Numbers: | MassGH, CDER |
Study First Received: | July 18, 2008 |
Last Updated: | February 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00720122 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Bone density Bone turnover markers Administered rhIGF-1 Elevations |
In biochemical indices Of bone turnover Increase Improvement Bone structure |
Mental Disorders Anorexia Anorexia Nervosa Eating Disorders |
Mental Disorders Anorexia Nervosa Eating Disorders |