Isolated idiopathic growth hormone deficiency. Hypopituitarism
Conditions
Interventions
Intervention 1: Control group: CinnaTropin® pen-injector (5 mg/1.5 mL, CinnaGen, Iran), SC injection of 0.03 mg/kg for one year. Intervention 2: Control group: Norditropin® NordiLet® pen (5 mg/1.5 mL,
Sponsors
CinnaGen company
Eligibility
Sex/Gender
All
Age
3 Years to 10 Years
Inclusion criteria
Inclusion criteria: GH-naïve Prepubertal (Tanner stage I) 3 to 10 years of age for male children and 3 to 8 years of age for female children Isolated idiopathic growth hormone deficiency diagnosed Peak growth hormone value of <10.0 µg/l following two recommended growth hormone stimulation tests Height Standard Deviation Score (HSDS) = -2.0 and Height Velocity Standard Deviation Score (HVSDS) =-1.0; or HSDS = -3.0 The ratio of bone age to chronological age < 0.9 Full-term birth weight above 2500 g Euthyroid state
Exclusion criteria
Exclusion criteria: Chronic systemic disease, such as diabetes mellitus or renal disease Evidence of active tumor Chromosomal or skeletal abnormalities Signs of idiopathic intracranial hypertension Closed epiphyses Chronic use of oral or parenteral glucocorticoid in the past three months Using methylphenidate in the last 14 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in height velocity. Timepoint: Prior to intervention and 12 months after the first intervention. Method of measurement: wall-mounted stadiometer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in height. Timepoint: Prior to intervention and 12 months after the first intervention. Method of measurement: wall-mounted stadiometer.;Change in weight. Timepoint: Prior to intervention and 12 months after the first intervention. Method of measurement: Weight measuring device.;Change in Height Standard Deviation Score (HSDS). Timepoint: Prior to intervention and 12 months after the first intervention. Method of measurement: Centers for Disease Control and Prevention clinical growth data.;Safety. Timepoint: At screening visit, first intervention, and 3, 6, 9, and 12 months after the first intervention. Method of measurement: Patient’s history, physical examination, and laboratory data.;Immunogenicity. Timepoint: Prior to first intervention and at 3, 6, 9, and 12 months after the first intervention. Method of measurement: Evaluation of the presence and titre of anti-drug antibody in the blood sample. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Nasim Anjidani
Orchid Pharmed Company
Outcome results
None listed