This study is conducted in Europe. The aim of this observational study is to collect data from children with Prader-Willi Syndrome, who have been treated off-label with Norditropin® for more than 12 months to seek approval for Norditropin® treatment with Prader-Willi Syndrome.
Study Type
OBSERVATIONAL
Enrollment
41
Prader-Willi syndrome children treated with at least one dose of Norditropin®
Unnamed facility
Arhus N, Denmark
Unnamed facility
Hildesheim, Germany
Unnamed facility
Zurich, Switzerland
Primary objective is to investigate changes in height Standard Deviation Score (SDS)
Time frame: in response to 12 months Norditropin® treatment in children with PWS (referenced to PWS population
Changes in height SDS from start of treatment to last observation during Norditropin treatment (referenced to PWS population1)
Time frame: at 12 months- and at last observation during Norditropin treatment
Change in body composition (DEXA, Bio impedance or stable isotope dilution)
Time frame: at 12 months- and at last observation during Norditropin treatment
Height velocity (HV) and change in HV
Time frame: at 12 months- and at last observation during Norditropin treatment
Glycated Fraction of Haemoglobin (HbA1c)
Time frame: at 12 months- and at last observation during Norditropin treatment
Insulin-Like Growth Factor-I (IGF-I)
Time frame: at 12 months- and at last observation during Norditropin treatment
Haematology
Time frame: at 12 months- and at last observation during Norditropin treatment
Thyroid-stimulating hormone (TSH) and active form of free thyroxin
Time frame: at 12 months- and at last observation during Norditropin treatment
Adverse Events.
Time frame: at 12 months- and at last observation during Norditropin treatment
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