Comparision of efficacy of PRHgh ( Daroopakhsh, Iran ) and Norditropin (Novo -Nordisk, Denmark) on growth of short stature children with Growth Hormone deficiency
- Conditions
- Growth Hormone Deficiency.(E23.0 Hypopituitarism(isolated GH deficiencyE23.0 Hyp
- Registration Number
- IRCT201206054794N5
- Lead Sponsor
- Daroupakhsh Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 74
I- Children>2y and in pre-pubertal stage (Tanner 1-2) with
A- short stature:1- Height > 2SD below the mean of age and sex or 2- Target height > 2 SD below MPH
or 3- Height < 3% or < 5% or
B- Growth failure:
1- SD decline in GV chart during 1 year without short stature or 2- 1 SD decline in GV chart during 1 year with short stature with GH deficiency (GH < 10 ng/ml after two provocation tests with clonidine and L-Dopa with Propanolol); II- children who have typical GH deficiency symptoms, Hypophysis tumor or surgery, head radiation with one abnormal GH provocation test; III- Known GH deficient children who were on GH therapy for1-3 years
Exclusion criteria:
1- Pubertal stage( > tanner2); 2- Chronic systemic disorders, hypothyroidism, Celiac, Skeletal dysplasia, chronic renal disease, Chromosomal abnormalities. Omit from the study:
1- Starting puberty; 2- More than two weeks GH therapy withdrawal; 3-No interest to follow up.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Height. Timepoint: every 3 months. Method of measurement: stediometer (cm).;Growth velocity. Timepoint: every 3 months. Method of measurement: cm/mo.;Ht SDS. Timepoint: every 3 months. Method of measurement: (Ht patient- Ht 50% )/ Ht SD.
- Secondary Outcome Measures
Name Time Method TFT. Timepoint: every 3 months. Method of measurement: Blood test.;IGF-I. Timepoint: every 3 months. Method of measurement: Blood test.;Weight,. Timepoint: every 3 months. Method of measurement: Scale (Kg).;FPG. Timepoint: every 3 months. Method of measurement: Blood test.;CBC. Timepoint: every 3 months. Method of measurement: Blood test.;Bone age. Timepoint: every 6 months. Method of measurement: Left hand radiography.