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Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa (814)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00720122
Recruitment Status : Completed
First Posted : July 22, 2008
Results First Posted : February 29, 2012
Last Update Posted : November 18, 2021
Sponsor:
Information provided by (Responsible Party):
Madhusmita Misra, Massachusetts General Hospital

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Disorder of Bone Density and Structure, Unspecified Drug: Recombinant human insulin like growth factor-1 (rhIGF-1) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Recombinant Human Insulin Like Growth Factor-1 (rhIGF-1) on Bone Metabolism in Adolescent Girls With Anorexia Nervosa
Study Start Date : July 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Density

Arms and Interventions
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Arm Intervention/treatment
Experimental: Anorexia Nervosa Females Drug: Recombinant human insulin like growth factor-1 (rhIGF-1)
Twice daily
Other Name: Tercica


Outcome Measures
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Primary Outcome Measures :
  1. Change in Spine Bone Density (g/cm^2) [ Time Frame: Baseline and 6 months ]
    Change in spine bone density over 6 months (6month data- baseline data). Bone density at the spine was assessed using dual energy x-ray absorptiometry at baseline and 6 months and the change in bone density over these 6 months was calculated.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Meet criteria for anorexia nervosa (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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720122


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Madhusmita Misra, MD MD
More Information
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Responsible Party: Madhusmita Misra, Asssociate Professor of Pediatrics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00720122    
Other Study ID Numbers: MassGH
CDER
First Posted: July 22, 2008    Key Record Dates
Results First Posted: February 29, 2012
Last Update Posted: November 18, 2021
Last Verified: October 2021
Keywords provided by Madhusmita Misra, Massachusetts General Hospital:
Bone density
Bone turnover markers
rhIGF-1
Bone structure
Anorexia nervosa
Additional relevant MeSH terms:
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Bone Diseases
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders
Musculoskeletal Diseases
Insulin
 Insulin, Globin Zinc
Mitogens
Mecasermin
Hypoglycemic Agents
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Growth Substances