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Completed

NCT Number: NCT00710307

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

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

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Key information

Conditions

Idiopathic Short Stature

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ipsen Central Contact

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sampling

Procedure

Blood samples will be collected at visit 1 (day 1) and at visit 2 (day 14 to 45).

Genetic analysis

Genetic

The sample for genetic analyses may be taken at Visit 1. The blood sample volume will be 6 mL.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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)

Acronym: EPIGROW

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 4, 2008
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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