Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients
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.
Growth Hormone Disorder
Adult Growth Hormone Deficiency
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Randomized Cross Over Double Blind Versus Placebo Trial Followed by an Open Phase Studying Effect of Norditropin® on Left Ventricular Mass of Growth Hormone Deficient Adult Patients|
- Left ventricular mass measured with ultrasonography [ Designated as safety issue: No ]
- Ventricular function indices assessed by cardiac ultrasonography [ Designated as safety issue: No ]
- Bone mineral density and body composition assessed by DEXA (Dual Energy X-Ray Absorptiometry) [ Designated as safety issue: No ]
- Quality of life using EQ5D (European Quality of Life 5 Dimensions) scales [ Designated as safety issue: No ]
- IGF-I (Insulin-Like Growth Factor I) concentration [ Designated as safety issue: No ]
|Study Start Date:||October 1998|
|Study Completion Date:||December 2002|
|Primary Completion Date:||December 2002 (Final data collection date for primary outcome measure)|
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.
|Placebo Comparator: Placebo||
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562834
|Paris, France, 75571|
|Study Director:||Catherine Boisson-Lesage, MD||Novo Nordisk Pharmaceutique SAS|