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

Idiopathic Short Stature Clinical Trial

— EPIGROW  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710307
• Other study ID #: 2-79-52800-001
• Status: Completed
• Start date: October 2008
• Est. completion date: January 2010

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dwarfism
• Idiopathic Short Stature

Intervention

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.

Locations

Country	Name	City	State
France	Ipsen Central Contact	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Day 1 for the first sample; between Day 14 and Day 45 for the second sample
Secondary	Proportion of patients with height = -3.0 SDS,and height > -3.0 SDS and = -2.5 SDS		Day 1
Secondary	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		Day 1 and Day 14-45
Secondary	Proportion of patients having presented at least one historical documented clinically significant episode of hypoglycaemia		Before the start of the study and during the study.
Secondary	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)		Day 1