This trial is conducted in Europe. The aim of this trial is to assess the effect of somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients with a growth hormone deficiency.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
22
Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months (randomised trial period) followed by an 12-month open-label trial period with somatropin.
Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months. After treatment in the randomised trial period, placebo will be discontinued.
Novo Nordisk Investigational Site
Angers, France
Left ventricular mass measured with ultrasonography
Ventricular function indices assessed by cardiac ultrasonography
Bone mineral density and body composition assessed by DEXA (Dual Energy X-Ray Absorptiometry)
Quality of life using EQ5D (European Quality of Life 5 Dimensions) scales
IGF-I (Insulin-Like Growth Factor I) concentration
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Novo Nordisk Investigational Site
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Caen, France
Novo Nordisk Investigational Site
Grenoble, France
Novo Nordisk Investigational Site
Le Kremlin-Bicêtre, France
Novo Nordisk Investigational Site
Lille, France
Novo Nordisk Investigational Site
Lorient, France
Novo Nordisk Investigational Site
Lyon, France
Novo Nordisk Investigational Site
Lyon, France
...and 14 more locations