Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function
ConditionRenal Osteodystrophy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDitte Hansen
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
estimated Glomerular Filtration Rate (eGFR) ≤ 20 ml/min/1,73m2
PTH < 150 pg/ml or PTH > 300 pg/ml
Disqualifiers
ongoing malignancy
Allergy towards tetracyclin
Pregnancy
eGFR >= 60 ml/min
Trial population
Patients under investigation for prostate cancer are recruited as bone healthy controls Patients with reduced renal function and suspected high or low bone turnover are recruited for bone biopsy, blood and urin samples and 18F-PET scan
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
18F-PET
Diagnostic testBone biopsy and 18F-PET
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: Low turnover bone disease1 intervention
Group B: High turnover bone disease1 intervention
Group C: Normal renal function1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
The bone biopsy and 18F-PET will be performed during two month for each participant2
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
Time frame
Blood sample and bone biopsy will be performed during two month for each participantSecondary outcomes
1
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
Time frame
The bone biopsy and 18F-PET will be performed during two month for each participant2
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
Time frame
Blood sample and bone biopsy will be performed during two month for each participantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ditte Hansen
Lead sponsor
Herlev Hospital
Sponsor institution
University of Copenhagen
Collaborator
Universiteit Antwerpen
Collaborator
Source ClinicalTrials.gov