Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function

Renal Osteodystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03716128
• Other study ID #: H-17040409
• Status: Recruiting
• Start date: September 26, 2018
• Est. completion date: October 2025

Study information

• Verified date: October 2023
• Source: Herlev Hospital
• Contact: Ditte Hansen, PhD
• Phone: +4538683868
• Email: ditte.hansen.04[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Kidney Disease-Mineral and Bone Disorder
• Renal Osteodystrophy

Intervention

Diagnostic Test:
• 18F-PET
Bone biopsy and 18F-PET

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (3)

Lead Sponsor	Collaborator
Ditte Hansen	Universiteit Antwerpen, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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