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Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents

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ClinicalTrials.gov Identifier: NCT00516386
Recruitment Status : Completed
First Posted : August 15, 2007
Results First Posted : August 4, 2011
Last Update Posted : November 18, 2021
Sponsor:
Collaborator:
Tercica
Information provided by (Responsible Party):
Madhusmita Misra, Massachusetts General Hospital

Study Description
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Brief Summary:
The purpose of this study was to determine whether giving insulin like growth factor-I (IGF-I) to adolescent low weight girls is safe and whether this increases levels of bone formation markers.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Drug: RhIGF-1 Phase 1 Phase 2

Detailed Description:

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 I (IGF-I), the bone trophic factor made in the liver in response to growth hormone (GH), despite elevated levels GH. It is possible that deficiency of IGF-I, a hormone very important for the maintenance of skeletal integrity, may contribute to the severe osteopenia seen in AN. The physiologic effects of rhIGF-I treatment in adolescents with AN had not been studied. The goal of this proposal was to investigate the acute effects of rhIGF-I on bone metabolism in adolescent girls with AN.

Specific Aim: It was hypothesized that adolescent AN patients, being IGF-I deficient, would respond to exogenously administered rhIGF-I with elevations in biochemical indices of bone turnover. Therefore, rhIGF-I was administered to AN patients by subcutaneous injection over 10 days with concomitant measurement of indices of bone turnover, and calcium regulatory hormones.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents
Study Start Date : March 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Insulin like growth factor- 1 (IGF-1)
Adolescent girls with AN meeting inclusion criteria were administered recombinant human (rh) rhIGF-1 at a dose of 35-40 mcg/k twice daily by subcutaneous injections for a 7-10 day period.
 Drug: RhIGF-1
35-40 mcg/k/dose twice daily SC
Other Name: Increlex


Outcome Measures
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Primary Outcome Measures :
  1. Change in Levels of Insulin Like Growth Factor-1 (IGF-I) Following Recombinant Human (rh) IGF-1 Administration in Girls With Anorexia Nervosa [ Time Frame: Baseline and 7-10 days ]

Secondary Outcome Measures :
  1. Change in Levels of N-terminal Propeptide of Type 1 Procollagen (P1NP) Following rhIGF-1 Administration in Girls With Anorexia Nervosa [ Time Frame: Baseline and 7-10 days ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescent girls with anorexia nervosa 12-18 years old

Exclusion Criteria:

  • Pregnancy or nursing
  • Hematocrit < 30%, K < 3 mmol/L
  • Any illness (other than anorexia nervosa) known to affect bone and mineral metabolism such as diabetes, alcoholism, untreated hypo- or hyperthyroidism, or hyperparathyroidism
  • History of use of any medicine, such as corticosteroids, known to affect bone density. Subjects who were on estrogen were still eligible to participate in the study.
Contacts and Locations
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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): NCT00516386


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Tercica
Investigators
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Principal Investigator: Madhu Misra Massachusetts General Hospital
More Information
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Publications:

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Responsible Party: Madhusmita Misra, Associate Professor of Pediatrics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00516386    
Other Study ID Numbers: 2006P-000737
First Posted: August 15, 2007    Key Record Dates
Results First Posted: August 4, 2011
Last Update Posted: November 18, 2021
Last Verified: October 2021
Keywords provided by Madhusmita Misra, Massachusetts General Hospital:
Adolescents
Anorexia nervosa (AN)
Bone formation markers
Insulin like growth factor-1 (IGF-I)
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
 Mental Disorders
Mecasermin
Growth Substances
Physiological Effects of Drugs