Growth Hormon Deficiency Clinical Trial
Official title:
Observational Long-term Follow-up of the Phase IV Open-label Trial of Predictive Markers in GHD and TS Pre-pubertal Children Treated With Saizen
Primary objective is to assess the relationship between changes from serum biomarkers observed after 1 month of Saizen® therapy and change in height, weight after up to 5 years of treatment with Growth Hormone in children with Growth Hormone Deficiency (GHD) and Turner Syndrome (TS).
This study is an observational study that will collect data from patients enrolled in a
previous study (PREDICT, NCT 00256126). Data such as auxological parameters (height, weight,
Tanner stage, bone age will be collected as well as GH treatment use (including dose and
adherence to the treatment).
Because for some countries the start of this long term follow up study will take place more
than one year after subjects have completed the initial study (PREDICT) retrospective data
may be collected (if subjects agree) as well as prospective data.
When available laboratory parameters such as IGF-1, IGFPB-3, fasting glucose, fasting
insulin, TSH and T4 will also be collected.
This data will be collected yearly during the normal follow up visits during 5 years.
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