Dettagli per singolo studio

DEC-NET Serial number ES530

Published online	18/04/2006 12.16.00
Last updated	24/04/2006 9.11.29

Other protocol ID number	24531
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	ARREST OF BONE DEVELOPMENT OR GROWTH
Experimental drug
Recombinant Growth Hormone (somatropin) Treatment regimen (dosage and duration) Standard dose to Growth Hormone Deficiency and Turner Syndrome.
Gender	Both
Age (range)	> 4 years old , prepubertal
Eligibility criteria


Exclusion criteria
Subjects with acquired GHD due to central nervous system disorders, such as tumors, trauma, infection, infiltration, irradiation, cranial surgery
Trial design/methodology
Phase	4
Kind of study
Design	Abierto sin grupo control
Purpose of study
Primary:- To identify the most responsive serum biomarkers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS)children Secondary:-To explore de contribution of selected genes to the phenotype of GHD and TS children -To explore the contribution of gene polymorphisms to the levels of serum biomarkers in GHD and TS children after one month of Saizen therapy -To explore the relationship between changes in gene expression profiling , the changes in serum biomarkers and the spectrum of gene polymorphisms in a subset of GH and TS children (defined as <25 and > 75 percentiles of IGF-1 levels) after one month of Saizen therapy.
Primary outcomes
The changes in serum IGF-1 levels after one month in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) children
Secondary outcomes
In Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) children after one month Saizen therapy: -The changes of IGBP-3 levels -The changes of glycemia and insulinemia, insulin resistance (HOMA-IR analysis) -The changes of alkaline phosphatase