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Study · Non-randomized trial · n = 76 · 2007

5 results

Long-term treatment with recombinant insulin-like growth factor (IGF)-I in children with severe IGF-I deficiency due to growth hormone insensitivity.

Chernausek SD, Backeljauw PF, Frane J, Kuntze J, Underwood LE

The Journal of clinical endocrinology and metabolism27 Dec 2006Cited by 152 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In children with severe IGF-I deficiency, rhIGF-I increased mean height velocity from 2.8 to 8.0 cm/yr during the first year.

    In plain wordsIn children with severe IGF-I deficiency, rhIGF-I increased growth speed from baseline during the first year.

    Outcome
    IncreaseFirst-year height velocity
    Study

    n = 76

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    60-120 microg/kg twice daily · subcutaneous · first year of treatmentAs given in this study (human).

    Measurements

    Height velocity at baseline
    2.8 cm/yr
    average at baseline
    Height velocity during first year of treatment
    8 cm/yr
    first year of treatment
    P value for height velocity increase
    < 0.0001 p value
    first year of rhIGF-I treatment versus baseline

    Source sentences

    Summary
    Height velocity increased from 2.8 cm/yr on average at baseline to 8.0 cm/yr during the first year of treatment (P < 0.0001) and was dependent on the dose administered.
    2 context sentences
    Summary · context
    Seventy-six children with IGF-I deficiency due to GH insensitivity were treated with rhIGF-I for up to 12 yr under a predominantly open-label design.
    Summary · context
    rhIGF-I was administered sc in doses between 60 and 120 microg/kg twice daily.
  2. 02HumanNon-randomized trialSafety outcome

    In children treated with rhIGF-I, 49% reported hypoglycemia, which also occurred before therapy.

    In plain wordsIn children receiving rhIGF-I, low blood sugar occurred before and during therapy.

    Outcome
    Not applicableHypoglycemia
    Study

    n = 76

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    60-120 microg/kg twice daily · subcutaneous · up to 12 yrAs given in this study (human).

    Measurements

    Subjects reporting hypoglycemia
    49%
    treated subjects

    Source sentences

    Summary
    The most common adverse event was hypoglycemia, which was observed both before and during therapy. It was reported by 49% of treated subjects.
    2 context sentences
    Summary · context
    Seventy-six children with IGF-I deficiency due to GH insensitivity were treated with rhIGF-I for up to 12 yr under a predominantly open-label design.
    Summary · context
    rhIGF-I was administered sc in doses between 60 and 120 microg/kg twice daily.
  3. 03HumanNon-randomized trialSafety outcome

    In children receiving rhIGF-I, injection site lipohypertrophy occurred in 32%.

    In plain wordsIn children receiving rhIGF-I, fat tissue enlargement occurred at injection sites.

    Outcome
    Not applicableInjection site lipohypertrophy
    Study

    n = 76

    Outcome group
    Adverse events · Skin and wound
    Studied dose
    60-120 microg/kg twice daily · subcutaneous · up to 12 yrAs given in this study (human).

    Measurements

    Subjects with injection site lipohypertrophy
    32%
    treated subjects

    Source sentences

    Summary
    The next most common adverse events were injection site lipohypertrophy (32%) and tonsillar/adenoidal hypertrophy (22%).
    2 context sentences
    Summary · context
    Seventy-six children with IGF-I deficiency due to GH insensitivity were treated with rhIGF-I for up to 12 yr under a predominantly open-label design.
    Summary · context
    rhIGF-I was administered sc in doses between 60 and 120 microg/kg twice daily.
  4. 04HumanNon-randomized trialSafety outcome

    In children receiving rhIGF-I, tonsillar/adenoidal hypertrophy occurred in 22%.

    In plain wordsIn children receiving rhIGF-I, enlarged tonsils or adenoids occurred.

    Outcome
    Not applicableTonsillar/adenoidal hypertrophy
    Study

    n = 76

    Outcome group
    Adverse events · Immune and inflammation
    Studied dose
    60-120 microg/kg twice daily · subcutaneous · up to 12 yrAs given in this study (human).

    Measurements

    Subjects with tonsillar/adenoidal hypertrophy
    22%
    treated subjects

    Source sentences

    Summary
    The next most common adverse events were injection site lipohypertrophy (32%) and tonsillar/adenoidal hypertrophy (22%).
    2 context sentences
    Summary · context
    Seventy-six children with IGF-I deficiency due to GH insensitivity were treated with rhIGF-I for up to 12 yr under a predominantly open-label design.
    Summary · context
    rhIGF-I was administered sc in doses between 60 and 120 microg/kg twice daily.
  5. 05HumanNon-randomized trialEfficacy outcome

    In children with severe IGF-I deficiency, height velocity remained above baseline for up to 8 yr despite later declines.

    In plain wordsIn children with severe IGF-I deficiency, growth speed remained above baseline during later rhIGF-I treatment.

    Outcome
    IncreaseLater height velocity
    Study

    n: not reported in source

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    60-120 microg/kg twice daily · subcutaneous · up to 12 yrAs given in this study (human).

    Source sentences

    Summary
    Height velocities were lower during subsequent years but remained above baseline for up to 8 yr.
    2 context sentences
    Summary · context
    Seventy-six children with IGF-I deficiency due to GH insensitivity were treated with rhIGF-I for up to 12 yr under a predominantly open-label design.
    Summary · context
    rhIGF-I was administered sc in doses between 60 and 120 microg/kg twice daily.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2/3Results postedNCT00571727

Long-Term Treatment With rhIGF-1 in GHIS

Ipsenn = 9220 May 1991 to 15 Dec 2011

Growth Hormone Insensitivity Syndrome

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    14 Oct 2026, 05:02 UTC

    Study results updated

  2. Version 1

    14 Oct 2026, 01:46 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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