Dettagli per singolo studio

DEC-NET Serial number FR525

Published online	06/07/2006 16.02.00
Last updated	06/07/2006 16.19.27

Other protocol ID number	CTN 307-MET-9002-0009
Current trial status	Closed to recruitment of participants: follow-up continuing
Major Disease (ICD9 class)	Lack of expected normal physiological development; Failure to gain weight; Short stature
Experimental drug
Somatropin Treatment regimen (dosage and duration) 1.4 IU/kg/week is given as a every day subcutaneous injection during 36 months
Gender	Both
Age (range)	3 years and above
Eligibility criteria
Inclusion criteria
-Children with juvenile arthritis or nephrotic syndrome -Chronoligical age> 3 years old -Before or during puberty -Treated by corticoids since at least 1 year with a posology < or equal 0.2mg/kg/d equivalent prednisone, every day or every other day, with continuation of this treatment during growth hormone administration -Height < -2,0 SD or loss of 1 SD during the 2 years preceding the inclusion -Bone age < 13 years for the girls and < 14 years for the boys -In pubertal patients : B2 < breast development < B3 for the girls, 4 ml < testicular volume < 12 ml for the boys -Informed consent signed.
Exclusion criteria
-Diabetes type 1 and 2, -Endocrine disease, expected well substitued hypothyroidism, -Chronic renal diseases with glomerular filtration rate < 50 ml/mn/1.73m2 ; -Patients who have know or supected allergy to the preservative m-cresol, -Non compliant patients, -Patients treated with sexual steroids (estrogens, testosterone) during the 6 months before the inclusion ; -Secondary resistance to the treatment of the nephrotic syndrome defined by proteinuria with albuminemia < 30g/l during more than 3 consecutive months ; -Malignancies, -Prviuos GH treatment, -Inclusion in other study protocol.
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety
Design
Purpose of study
Principal objective: -To assess the effect of a long-term treatment by Genotonorm on linear growth in children with short stature receiving steroid therapy. Secondary objectives: - to assess of a long term treatment with Genotonorm on bone mineralisation and body composition. - to assess the clinical and biological (glucose and lipid metabolism) safety with Genotonorm treatment
Primary outcomes
The main efficacy variable is the height SDS (SEMPE)
Secondary outcomes
- Bone metabolism - Body composition
Summary of study design, objectives, and ongoing research findings
This is a national, multicentre, not randomized and not controlled study. The primary objective is to evaluate the efficacy of recombinant human growth hormone treatment on children' growth having a short stature due to long term corticoid therapy.The children above the age of 3 years are treated by Genotonorm (0.46 mg/kg/week) treatment is maintained until they reach their final height.