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Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa (814)
This study is currently recruiting participants.
Verified by Massachusetts General Hospital, February 2009
First Received: July 18, 2008   Last Updated: February 9, 2009   History of Changes
Sponsored by: Massachusetts General Hospital
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00720122
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Bone density [ Time Frame: Six Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone Turnover Markers [ Time Frame: Six Months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   12 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet criteria for AN as described in the Diagnostic and Statistical Manual of Mental Disorders

Exclusion Criteria:

  • Pregnant or nursing
  • Hematocrit < 30%, K < 3 mmol/L
  • Any illness (other than AN) known to affect bone and mineral metabolism such as diabetes, untreated hypo- or hyperthyroidism, or hyperparathyroidism
  • History of use of any medicine, such as corticosteroids, known to affect bone density. Subjects who are on estrogen will still be eligible to participate in the study because our data in adult women with AN do not indicate deleterious effects of estrogen in patients receiving rhIGF-
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720122

Contacts
Contact: Melissa Russell, MD 6177261428 mrussell@partners.org
Contact: Madhu Misra, MD 6177245602 mmisra@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Madhu Misra, MD     617-724-5602     mmisra@partners.org    
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Madhusmita Misra, MD MD
  More Information

No publications provided

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

Keywords provided by Massachusetts General Hospital:
Bone density
Bone turnover markers
Administered
rhIGF-1
Elevations
In biochemical indices
Of bone turnover
Increase
Improvement
Bone structure

Study placed in the following topic categories:
Mental Disorders
Anorexia
Anorexia Nervosa
Eating Disorders

Additional relevant MeSH terms:
Mental Disorders
Anorexia Nervosa
Eating Disorders

ClinicalTrials.gov processed this record on September 09, 2009