Clinical Trial: Epidemiology Study on Insulin-like Growth Factor-1 in Children With Idiopathic Short Stature (EPIGROW Study)
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
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
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
Detailed Summary:
Sponsor: Ipsen
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion of patients with height ≤ -3.0 SDS,and height > -3.0 SDS and ≤ -2.5 SDS [ Time Frame: Day 1 ]
- 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 ]
- 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. ]
- 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 ]
Original Secondary Outcome: Same as current
Information By: Ipsen
Dates:
Date Received: July 2, 2008
Date Started: October 2008
Date Completion:
Last Updated: September 9, 2010
Last Verified: September 2010
