Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 13, 2007
CompletedFirst Posted
Study publicly available on registry
August 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
August 4, 2011
CompletedNovember 18, 2021
October 1, 2021
1.2 years
August 13, 2007
November 23, 2010
October 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Levels of Insulin Like Growth Factor-1 (IGF-I) Following Recombinant Human (rh) IGF-1 Administration in Girls With Anorexia Nervosa
Baseline and 7-10 days
Secondary Outcomes (1)
Change in Levels of N-terminal Propeptide of Type 1 Procollagen (P1NP) Following rhIGF-1 Administration in Girls With Anorexia Nervosa
Baseline and 7-10 days
Study Arms (1)
Insulin like growth factor- 1 (IGF-1)
EXPERIMENTALAdolescent 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.
Interventions
35-40 mcg/k/dose twice daily SC
Eligibility Criteria
You may qualify if:
- Adolescent girls with anorexia nervosa 12-18 years old
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Tercicacollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (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. doi: 10.1016/j.bone.2009.06.002. Epub 2009 Jun 10.
PMID: 19523548BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
A limitation of our study is that this was not a randomized controlled trial of rhIGF-1 versus placebo.
Results Point of Contact
- Title
- Madhu Misra, MD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Madhu Misra
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
August 13, 2007
First Posted
August 15, 2007
Study Start
March 1, 2007
Primary Completion
May 1, 2008
Study Completion
December 1, 2008
Last Updated
November 18, 2021
Results First Posted
August 4, 2011
Record last verified: 2021-10