Renal Osteodystrophy
Conditions
Brief summary
The aim of the study is to 1. To describe the bone morphology in patients with reduced renal function and high or low parathyroid hormone (PTH) respectively. 2. To investigate if the non-invasive method 18-Fluoride Positron Emission Tomography (18F-PET) can describe the bone turnover and reflect the bone histomorphologic changes 3. To investigate if non-oxidized PTH reflects bone turnover
Detailed description
Patients with reduced renal function and suspected high turnover or low turnover bone disease are recruited. A bone biopsy and a 18F-PET scan are performed and it is investigated if the 18F-PET can discriminate high turnover from low turnover bone disease
Interventions
DIAGNOSTIC_TEST18F-PET
Bone biopsy and 18F-PET
Sponsors
University of Copenhagen
Universiteit Antwerpen
Ditte Hansen
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with reduced renal function: Inclusion Criteria: -≥ 18 years * estimated Glomerular Filtration Rate (eGFR) ≤ 20 ml/min/1,73m2 * PTH \< 150 pg/ml or PTH \> 300 pg/ml
Exclusion criteria
* ongoing malignancy * Allergy towards tetracyclin * Pregnancy Control Group: Inclusion Criteria: -≥ 18 years * eGFR \>= 60 ml/min * under examination for c prostata * Prostatic Specific Antigen (PSA) total \<40 µg/l Exclusion: * Former kidney disease * ionized calcium or PTH outside normal range * Known metabolic bone disease * treatment with anticoagulants * Disturbed thrombosis and hemostasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Can 18F-PET-CT describe bone formation rate? | The bone biopsy and 18F-PET will be performed during two month for each participant | The ROC curve for 18F uptake by bone measured as bone plasma clearance (ki) to descriminate between high and low bone turnover measured as bone formation rate |
| Can non-oxidized PTH describe bone formation rate? | Blood sample and bone biopsy will be performed during two month for each participant | The relation between non-oxidized PTH in ng/L and bone turnover in bone biopsy described as bone formation rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Can 18F-PET-CT describe mineral apposition rate? | The bone biopsy and 18F-PET will be performed during two month for each participant | The ROC curve for 18F uptake by bone measured as bone plasma clearance (ki) to descriminate between high and low bone turnover measured as mineral apposition rate |
| Can non-oxidized PTH describe mineral apposition rate? | Blood sample and bone biopsy will be performed during two month for each participant | The relation between non-oxidized PTH in ng/L and bone turnover in bone biopsy described as mineral apposition rate |
Countries
Denmark
Contacts
Primary ContactDitte Hansen, PhD
Outcome results
None listed