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

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RhIGF-1
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anorexia Nervosa focused on measuring Adolescents, Anorexia nervosa (AN), Bone formation markers, Insulin like growth factor-1 (IGF-I)

Eligibility Criteria

12 Years - 18 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Insulin like growth factor- 1 (IGF-1)

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Levels of Insulin Like Growth Factor-1 (IGF-I) Following Recombinant Human (rh) IGF-1 Administration in Girls With Anorexia Nervosa

Secondary Outcome Measures

Change in Levels of N-terminal Propeptide of Type 1 Procollagen (P1NP) Following rhIGF-1 Administration in Girls With Anorexia Nervosa

Full Information

First Posted
August 13, 2007
Last Updated
October 22, 2021
Sponsor
Massachusetts General Hospital
Collaborators
Tercica
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1. Study Identification

Unique Protocol Identification Number
NCT00516386
Brief Title
Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents
Official Title
Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Tercica

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Adolescents, Anorexia nervosa (AN), Bone formation markers, Insulin like growth factor-1 (IGF-I)

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin like growth factor- 1 (IGF-1)
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
RhIGF-1
Other Intervention Name(s)
Increlex
Intervention Description
35-40 mcg/k/dose twice daily SC
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhu Misra
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19523548
Citation
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.
Results Reference
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Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents

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