This trial is conducted in Europe. The aim of this trial is to assess whether increasing doses of somatropin (Norditropin®) can maintain the initial increase in height velocity and improve final height. This trial has two trial periods, a main period of 4 years and an extension period until final height is reached.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
4 IU/m\^2 body surface for 4 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection
Initial dose 4 IU/m\^2 body surface the first year, then 6 IU/m\^2 body surface for 3 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection
Initial dose 4 IU/m\^2 body surface the first year, then 6 IU/m\^2 body surface, the second year and finally 8 IU/m\^2 body surface for 2 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection
Novo Nordisk Investigational Site
Alphen aan den Rijn, Netherlands
Final height
Height velocity (cm/year)
Ratio between change in bone age and change in chronological age
Age at onset of puberty
Adverse events
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Treatment with oestrogen was administered if spontaneous puberty had not occurred by age 12 years and was initiated in the extension period after at least four years of somatropin treatment