Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function

NCT03716128 | Recruiting DMC

• 1 other identifier: H-17040409
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to

1. 1.To describe the bone morphology in patients with reduced renal function and high or low parathyroid hormone (PTH) respectively.
2. 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. 3.To investigate if non-oxidized PTH reflects bone turnover

Conditions

Renal Osteodystrophy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Can 18F-PET-CT describe 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?

  Blood sample and bone biopsy will be performed during two month for each participant

Study Arms (3)

Low turnover bone disease

PTH\<150 pg/ml

Diagnostic Test: 18F-PET

High turnover bone disease

PTH\>300 pg/ml

Diagnostic Test: 18F-PET

Normal renal function

Patients under examination for prostate cancer

Diagnostic Test: 18F-PET

Interventions

18F-PET DIAGNOSTIC_TEST

Bone biopsy and 18F-PET

Also known as: Bone biopsy

High turnover bone disease; Low turnover bone disease; Normal renal function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• ≥ 18 years
• estimated Glomerular Filtration Rate (eGFR) ≤ 20 ml/min/1,73m2
• PTH \< 150 pg/ml or PTH \> 300 pg/ml

You may not qualify if:

• ongoing malignancy
• Allergy towards tetracyclin
• Pregnancy
• Control Group:
• ≥ 18 years
• eGFR \>= 60 ml/min
• under examination for c prostata
• Prostatic Specific Antigen (PSA) total \<40 µg/l
• Former kidney disease
• ionized calcium or PTH outside normal range
• Known metabolic bone disease
• treatment with anticoagulants
• Disturbed thrombosis and hemostasis

Sponsors & Collaborators

• Ditte Hansen: lead
• University of Copenhagen: collaborator
• Universiteit Antwerpen: collaborator

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bone Biopsy

MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ditte Hansen, PhD

CONTACT

+4538683868; ditte.hansen.04@regionh.dk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 23, 2018
• Study Start: September 26, 2018
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)