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
Study Type
OBSERVATIONAL
Enrollment
275
Blood samples will be collected at visit 1 (day 1) and at visit 2 (day 14 to 45).
The sample for genetic analyses may be taken at Visit 1. The blood sample volume will be 6 mL.
Ipsen Central Contact
Paris, France
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
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
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