Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function

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

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

Study Overview

• Status: Recruiting
• Conditions: Renal Osteodystrophy
• Intervention / Treatment: Diagnostic test: 18F-PET

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 Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Ditte Hansen, PhD; Phone Number: +4538683868; Email: ditte.hansen.04@regionh.dk

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Recruiting
    • Herlev Hospital
    • Contact: Ditte Hansen, PhD; Phone Number: +4538683868; Email: ditte.hansen.04@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low turnover bone disease; PTH<150 pg/ml	Diagnostic test: 18F-PET; Bone biopsy and 18F-PET; Other Names: Bone biopsy
High turnover bone disease; PTH>300 pg/ml	Diagnostic test: 18F-PET; Bone biopsy and 18F-PET; Other Names: Bone biopsy
Normal renal function; Patients under examination for prostate cancer	Diagnostic test: 18F-PET; Bone biopsy and 18F-PET; Other Names: Bone biopsy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ditte Hansen
• Collaborators: University of Copenhagen; Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2018
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: October 20, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Nutrition Disorders; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Bone Diseases, Metabolic; Parathyroid Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Rickets; Calcium Metabolism Disorders; Vitamin D Deficiency; Hyperparathyroidism, Secondary; Hyperparathyroidism; Chronic Kidney Disease-Mineral and Bone Disorder
• Other Study ID Numbers: H-17040409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No