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 : January 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Nervosa||Drug: RhIGF-1||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
35-40 mcg/k/dose twice daily SC
Other Name: Increlex
- 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 ]
- 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 ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516386
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Madhu Misra||Massachusetts General Hospital|