15
Participants
Start Date
March 31, 2013
Primary Completion Date
March 31, 2021
Study Completion Date
March 31, 2021
SOMATROPINE* : Norditropine® simplexx®
SOMATROPINE\* : Norditropine® simplexx® - 15 mg/1,5 ml, injectable solution:Treatment with hGH is administered at a dose of 0.05 mg / kg / day (0.35 mg / kg / week) subcutaneously daily, preferably in the evening. The dose of hGH treatment will be adjusted according to weight gain, and reduced by 10% if the serum values of IGF-I SDS above 2.5 on 2 consecutive determinations at 3-month intervals are discovered by the biologist.
Placebo
Treatment with placebo is administered at a dose of 0.05 mg / kg / day (0.35 mg / kg / week) subcutaneously daily, preferably in the evening. The dose of placebo will be adjusted according to weight gain, and reduced by 10% if the serum values of IGF-I SDS above 2.5 on 2 consecutive determinations at 3-month intervals are discovered by the biologist.
Robert Debré Hospital, Paris
Collaborators (1)
Novo Nordisk A/S
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER