Biochemical Markers of Growth Response to Growth Hormone Treatment in Children With Idiopathic Short Stature
Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
Summary
One arm, open, prospective, intervention study to assess biochemical markers of growth
response to Growth Hormone treatment in 20 Children, aged 3-9 years old, with idiopathic
short stature. All participants will be treated with Growth Hormone during the first year of
the study (and then in accordance with the local ethic requirement, to supply drug which is
not approved for the indication used in the study, for additional 3 years) and then will be
followed up for the next 3 years. The impact of Growth Hormone therapy on clinical laboratory
parameters that are indicative of the growth response will be assessed by collecting blood
and urine samples during the 4 years study period. The primary endpoints are measurements of
height and growth velocity during the year of Growth Hormone treatment, the height at the
beginning of puberty and final height. Secondary endpoints are psychological parameters,
assessed by questionnaires.