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Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

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

NCTNCT00516386 (opens ClinicalTrials.gov in a new tab)Other id2006P-000737
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
16 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Mar 2007
Primary completion
May 2008
Completion
Dec 2008
First posted
15 Aug 2007 (estimated)
Last update posted
18 Nov 2021
Conditions
Anorexia Nervosa

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009
  1. Ph 1/2

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

    NCT00516386

    Mar 2007 to Dec 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • RhIGF-1Drug

Arms1

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  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 outcomes(1)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and 7-10 days

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

GroupValue (ng/ml)Spread
RhIGF-1542.940.9
Secondary and other outcome results(1)
Secondary outcomeMean· 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

GroupValue (ng/ml)Spread
RhIGF-139.39.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
RhIGF-1All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.–1 / 164 / 16

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2009

6 results

Effects of rhIGF-1 administration on surrogate markers of bone turnover in adolescents with anorexia nervosa.

Misra et al. 2009Bonecited by 64

PMID 19523548PMC3590307DOI 10.1016/j.bone.2009.06.002PUB-19523548

Rights unknown6 results
Source linkSee results (6)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 12 Years up to 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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