Renal Osteodystrophy Clinical Trial
Official title:
Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function Can 18F-PET Replace Bone Histomorphometry
NCT number | NCT03716128 |
Other study ID # | H-17040409 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 26, 2018 |
Est. completion date | October 2025 |
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
Status | Recruiting |
Enrollment | 40 |
Est. completion date | October 2025 |
Est. primary completion date | October 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Herlev Hospital | Herlev |
Lead Sponsor | Collaborator |
---|---|
Ditte Hansen | Universiteit Antwerpen, University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Can 18F-PET-CT describe bone formation rate? | 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 | The bone biopsy and 18F-PET will be performed during two month for each participant | |
Primary | Can non-oxidized PTH describe bone formation rate? | The relation between non-oxidized PTH in ng/L and bone turnover in bone biopsy described as bone formation rate | Blood sample and bone biopsy will be performed during two month for each participant | |
Secondary | Can 18F-PET-CT describe mineral apposition rate? | 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 | The bone biopsy and 18F-PET will be performed during two month for each participant | |
Secondary | Can non-oxidized PTH describe mineral apposition rate? | The relation between non-oxidized PTH in ng/L and bone turnover in bone biopsy described as mineral apposition rate | Blood sample and bone biopsy will be performed during two month for each participant |
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