Growth hormone and androgens in the treatment of glucocorticoid induced protein catabolism - GH and androgens in protein catabolism
- Conditions
- Chronic treatment with glucocorticoids (GCs) regardless of indication leads to marked protein catabolism that causes substantial debilitation which includes muscle wasting, weakness, skin fragility, bruising, poor wound healing and osteoporosis. The selection of subjects is therefore patients with polymyalgia rheumatica or inflammatory arthitis receiving long-term GC treatment.
- Registration Number
- EUCTR2005-003750-10-SE
- Lead Sponsor
- VästraGötaland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 12
· 12 men with polymyalgia rheumatica or inflammatory arthritis in remission > 6 months
Age 50-80 yr.
Body mass index 20-30 kg/m2
Glucocorticoid therapy for > 12 months
Stable dose of prednisolone of between 5-10 mg/day during > 3 months
Written informed consent of the patient
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
Diabetes mellitus
Congestive heart failure
Significant hepatic dysfunction with persistent elevation of transaminases >2 x upper limit of normal
Significant renal dysfunction with serum creatinine > 150 micromol/L
History of cancer
Patients needing assistance in activity of daily life
Any other hormonal treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method