Epidemiology Study on Insulin-Like Growth Factor-1 in Children With Idiopathic Short Stature (EPIGROW Study) - Full Text View

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00710307

Purpose

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	Phase
Idiopathic Short Stature	Phase IV

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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)

Further study details as provided by Ipsen:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with height ≤ -3.0 SDS,and height > -3.0 SDS and ≤ -2.5 SDS [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Idiopathic Short Stature children

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710307

Contacts

Contact: Ipsen Recruitment Enquiries

clinical.trials@ipsen.com

Locations

France
Ipsen Central Contact	Recruiting
Paris, France
Contact clinical.trials@ipsen.com

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Pacale Dutailly

Ipsen

More Information

No publications provided

Responsible Party:	Ipsen ( Pascale Dutailly )
Study ID Numbers:	2-79-52800-001
Study First Received:	July 2, 2008
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00710307 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Study placed in the following topic categories:

Mitogens
Insulin

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Mitosis Modulators
Mitogens
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009