This is a study in growth hormone deficient adult patients on stable growth hormone therapy of discountinuate growth hormone (GH) for 4 months in double blinded crossover, palcebo/controlled, randomised study design.
Conditions
Interventions
Trade Name: Norditropin SimplexX (5mg/1,5 ml) (INN:somatropin)
Product Name: Norditropin SimplexX
Product Code: NA
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solut
Sponsors
Endocrine Department, Sahlgrenska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Sixty patients with well defined GHD who have had GH replacement therapy for more than 3 years are eligible for participation. Patients will all be well known from our own out-patient clinic. Inclusions criteria • Men or women with well defined GH deficiency before commencement of GH substitution • More than 3 years of continuous GH treatment • Age 25-75 years • Well-defined hypopituitary-hypothalamic disorder. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Active malignancy • Heart failure • Respiratory insufficiency • Patient who may or cannot attend to the protocol according to the investigators opinion. • Pregnancy or lactating • Diabetes mellitus with proliferative retinopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim is to evaluate the short-term effects of discontinuing GH replacement therapy on quality of life and well-being in adults who have been on long-term GH replacement therapy.;Secondary Objective: Secondary aims are to study effects of discontinuing GH on: •Visceral adiposity •Body composition •Glucose metabolism •Lipid metabolism •Bone metabolism ;Primary end point(s): | — |
Countries
Sweden
Outcome results
None listed