Adult Growth Hormone Deficiency, Growth Hormone Disorder
Conditions
Brief summary
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.
Interventions
DRUGsomatropin
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.
DRUGplacebo
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.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Childhood or adult onset growth hormone deficiency (GHD) * GHD evidenced by two stimulation tests * Duration of GHD at least 5 years * Other hormone deficiencies associated with growth hormone deficiency
Exclusion criteria
* Pregnancy or pregnancy desired during the suggested duration of the study * Personal history of colonic polyp or family history of colonic polyposis * Known insulin-dependent or non-insulin-dependent diabetes * Cardiovascular disease, left ventricular hypertrophy from other aetiology, recent auricular or ventricular arrhythmia, history of vascularisation by aortocoronary bypass significative mitral or aortic valvular disease, preexcitation syndrome, auriculoventricular conduction delay, bradycardia-tachycardia syndrome, left ventricular mass interfering treatment * BMI (Body Mass Index) at least 30 * Growth hormone treatment during the 24 months prior to inclusion, history of treatment with extractive pituitary growth hormone, allergy or suspected allergy to somatropin therapy * Patient who has participated in a different clinical study within the past two months * Any condition which, in the opinion of the Investigator or the Scientific Committee, may interfere with successful implementation of the study * Notion of breast cancer for the mother or the sister
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular mass measured with ultrasonography | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life using EQ5D (European Quality of Life 5 Dimensions) scales | — |
| IGF-I (Insulin-Like Growth Factor I) concentration | — |
| Ventricular function indices assessed by cardiac ultrasonography | — |
| Bone mineral density and body composition assessed by DEXA (Dual Energy X-Ray Absorptiometry) | — |
Countries
France
Outcome results
None listed