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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Madhusmita Misra, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00720122
First received: July 18, 2008
Last updated: February 28, 2012
Last verified: February 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in Spine Bone Density (g/cm^2) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 28
Study Start Date: July 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anorexia Nervosa Females Drug: Recombinant human insulin like growth factor-1 (rhIGF-1)
Twice daily
Other Name: Tercica

  Eligibility

Ages Eligible for Study:   12 Years to 26 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720122

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Madhusmita Misra, MD MD
  More Information

No publications provided

Responsible Party: Madhusmita Misra, Asssociate Professor of Pediatrics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00720122     History of Changes
Other Study ID Numbers: MassGH, CDER
Study First Received: July 18, 2008
Results First Received: January 27, 2012
Last Updated: February 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Bone density
Bone turnover markers
rhIGF-1
Bone structure
Anorexia nervosa

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Bone Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
Musculoskeletal Diseases
 Mitogens
Insulin
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013