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

This study has been completed.
Sponsor:
Collaborator:
Tercica
Information provided by (Responsible Party):
Madhusmita Misra, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00516386
First received: August 13, 2007
Last updated: December 10, 2013
Last verified: December 2013

August 13, 2007
December 10, 2013
March 2007
May 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Safety profile of IGF-I administration in low weight adolescents [ Time Frame: One month ]
Complete list of historical versions of study NCT00516386 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Effect of IGF-I on bone formation markers [ Time Frame: 1 month ]
Not Provided
Not Provided
 
Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents
Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Anorexia Nervosa
Drug: RhIGF-1
35-40 mcg/k/dose twice daily SC
Other Name: Increlex
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.
Intervention: Drug: RhIGF-1
Misra M, McGrane J, Miller KK, Goldstein MA, Ebrahimi S, Weigel T, Klibanski A. Effects of rhIGF-1 administration on surrogate markers of bone turnover in adolescents with anorexia nervosa. Bone. 2009 Sep;45(3):493-8. Epub 2009 Jun 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2008
May 2008   (final data collection date for primary outcome measure)

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.
Female
12 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00516386
2006P-000737
Yes
Madhusmita Misra, Massachusetts General Hospital
Massachusetts General Hospital
Tercica
Principal Investigator: Madhu Misra Massachusetts General Hospital
Massachusetts General Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP