A bone scan in combination with some specific blood samples for the classification of bone disease in patients suffering from chronic kidney disease.
Phase 1
- Conditions
- Chronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD), especially renal osteodystofi.MedDRA version: 20.0 Level: LLT Classification code 10065404 Term: Combined positron emission tomogram and computerised tomogram System Organ Class: 10022891 - InvestigationsMedDRA version: 20.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - InvestigationsMedDRA version: 20.0 Level: LLT Classification code 10066622 Term: Chronic hemodialysis System Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2016-005160-34-DK
- Lead Sponsor
- niversitetsklinikken for Nyresygdomme og Blodtryksforhøjelse, Regionshospitalet Holstebro, Hospitalsenheden Vest
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Age 30-80 years
Chronic hemodialysis
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
Exclusion Criteria
Medical treatment with systemic corticosteroid
Inability to give informed consent
Pregnancy and lactation
Not radically treated cancer disease
Alcohol or drugs abuse
Within three months: bone fracture, AMI or TCI, parathyroidektomi or kidney transplantation
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