growth hormone deficiency, growth hormone treatment, dose response study
Conditions
Interventions
Two doses of biosynthetic GH:
0.7 mg/m2/d (~0.025 mg/kg/d) or 1.4 mg/m2/d (~0.050 mg/kg/d).
Sponsors
Novo Nordisk A/S Denmark
Eligibility
Inclusion criteria
Inclusion criteria: 1. Documented GHD of organic or idiopathic origin, including isolated GHD as well as multiple pituitary hormone deficiencies; 2. BA < 12 for boys and < 10 yr for girls, determined according to the procedure of Tanner and Whitehouse, 20 bones (TW2-20) 3. Normal serum T4 levels 4. No signs of puberty
Exclusion criteria
Exclusion criteria: 1. Growth retardation due to diabetes mellitus, inborn error of metabolism, primary bone disease, disorders of cardiopulmonary, gastrointestinal, genitourinary, or nervous tracts, or serious suspicion of psychosocial dwarfism; 2. Any kind of drug that might interfere with GH therapy, with the exception of replacement doses of T4 and/or hydrocortisone in multiple hormone deficiencies; 3. Insufficient growth response to previous GH therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Adult height; attained AH minus target height (TH) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Adverse events - Timing of puberty - Bone maturation | — |
Contacts
Public ContactT.C.J. Sas
Leids University Medical Center
Outcome results
None listed