Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function

Study Overview
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Brief Summary
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The aim of the study is to To describe the bone morphology in patients with reduced renal function and high or low parathyroid hormone (PTH) respectively. 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 To investigate if non-oxidized PTH reflects bone turnover

Detailed Description
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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

Official Title
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Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function Can 18F-PET Replace Bone Histomorphometry

Conditions
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Renal Osteodystrophy

Intervention / Treatment
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* Diagnostic Test: 18F-PET


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low turnover bone disease<br>PTH<150 pg/ml | Diagnostic Test: 18F-PET<br>* Bone biopsy and 18F-PET<br>* Other names: Bone biopsy;|
| High turnover bone disease<br>PTH>300 pg/ml | Diagnostic Test: 18F-PET<br>* Bone biopsy and 18F-PET<br>* Other names: Bone biopsy;|
| Normal renal function<br>Patients under examination for prostate cancer | Diagnostic Test: 18F-PET<br>* Bone biopsy and 18F-PET<br>* Other names: Bone biopsy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |