Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function

Recruiting

• Conditions: Renal Osteodystrophy
• Interventions: Diagnostic Test: 18F-PET

• Registration Number: NCT03716128
• Lead Sponsor: Ditte Hansen

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

Study Timeline

• Study Start: 2018-09-26
• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-10-20
• Study First Posted: 2018-10-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low turnover bone disease	18F-PET	PTH\<150 pg/ml
Normal renal function	18F-PET	Patients under examination for prostate cancer
High turnover bone disease	18F-PET	PTH\>300 pg/ml

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark