Epidemiology Study on Insulin-like Growth Factor-1 in Children With Idiopathic Short Stature (EPIGROW Study) (EPIGROW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00710307
Recruitment Status : Completed
First Posted : July 4, 2008
Last Update Posted : September 10, 2010
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Brief Summary:
The purpose of the protocol is to describe the distribution of IGF-1 deficiency in the studied population of Idiopathic Short Children without Growth Hormone Deficiency or any other identified cause of short stature and not treated with recombinant Growth Hormone or IGF-1

Condition or disease Intervention/treatment
Idiopathic Short Stature Procedure: Blood sampling Genetic: Genetic analysis

Study Type : Observational
Actual Enrollment : 275 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Descriptive, Cross-sectional and Prospective Epidemiology Study, on the Identification of Insulin-like Growth Factor-1 Status in Idiopathic Short Stature Children (EPIGROW Study)
Study Start Date : October 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dwarfism
Drug Information available for: Mecasermin

Intervention Details:
  • Procedure: Blood sampling
    Blood samples will be collected at visit 1 (day 1) and at visit 2 (day 14 to 45).
  • Genetic: Genetic analysis
    The sample for genetic analyses may be taken at Visit 1. The blood sample volume will be 6 mL.

Primary Outcome Measures :
  1. Proportion of patients with a mean of the two basal IGF-1 measurements ≤-2.0 SDS, > -2.0 SDS and below 0 SDS, ≥ 0.0 SDS [ Time Frame: Day 1 for the first sample; between Day 14 and Day 45 for the second sample ]

Secondary Outcome Measures :
  1. Proportion of patients with height ≤ -3.0 SDS,and height > -3.0 SDS and ≤ -2.5 SDS [ Time Frame: Day 1 ]
  2. Description of mean basal IGF-1 and IGFBP-3 levels, and basal ALS and prolactin levels in patients with height ≤ -3.0 SDS, and height > -3.0 SDS and ≤ -2.5 SDS [ Time Frame: Day 1 and Day 14-45 ]
  3. Proportion of patients having presented at least one historical documented clinically significant episode of hypoglycaemia [ Time Frame: Before the start of the study and during the study. ]
  4. Identification of candidate genes and/or DNA aberrations or changes potentially associated with short stature. DNA regions identified during the genome-wide scan will be further mapped at higher resolution (DNA-sequencing) [ Time Frame: Day 1 ]

Biospecimen Retention:   Samples With DNA
Whole blood will be collected. The blood sample will be kept as long as necessary and for a maximum of 5 years.

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Idiopathic Short Stature children

Inclusion Criteria:

  • Short children, height ≤ -2.5 SDS
  • Age ≥ 2 years
  • With at least one normal or elevated peak GH response to a stimulatory test (peak GH ≥ 7 ng/mL) at the time of the study and/or at a given time-point during the last 12 months
  • Pre-pubertal
  • Signed Informed Consent, including agreement to have blood samples taken for hormonal measurement and genetic analysis, by both parents or by Legally Acceptable Representatives when applicable and the child when applicable

Exclusion Criteria:

  • The following identified causes of short stature:
  • GH-deficient short stature
  • Other endocrine causes (hypothyroidism, Cushing's syndrome, parathyroid or vitamin D disorders, hypogonadism)
  • Identified syndromes with genetic abnormalities (including Turner, Noonan and Russell-Silver syndromes)
  • Chronic diseases including malnutrition, coeliac disease, chronic inflammation, muscular dystrophy, thalassaemia, blood disorders, severe liver or kidney disease and severe cyanotic heart disease
  • Chronic diseases requiring treatment with chronically administered corticosteroids
  • Skeletal dysplasia
  • Psychosocial short stature
  • Patients having received irradiation, including total body irradiation
  • Patients currently on GH or IGF-1 therapy or having received GH or IGF-1 therapy in the last 12 months
  • Patients likely to require GH, IGF-1 or chronic corticosteroid treatment during the study
  • Any mental condition that prevents both parents or Legally Acceptable Representatives and the child when applicable from understanding the nature, scope and possible consequences of the study, or any evidence of an uncooperative attitude

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00710307

Ipsen Central Contact
Paris, France
Sponsors and Collaborators
Study Director: Pacale Dutailly Ipsen

Responsible Party: Pascale Dutailly, Ipsen Identifier: NCT00710307     History of Changes
Other Study ID Numbers: 2-79-52800-001
First Posted: July 4, 2008    Key Record Dates
Last Update Posted: September 10, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs