Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function

Ditte Hansen

Status: Enrolling

Conditions: Renal Osteodystrophy

Treatments: Diagnostic Test: 18F-PET

Study type: Observational

Funder types: Other

Identifiers

NCT03716128

H-17040409

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

40 participants in 3 patient groups

Low turnover bone disease

Description:

PTH\<150 pg/ml

Treatment:

Diagnostic Test: 18F-PET

High turnover bone disease

Description:

PTH\>300 pg/ml

Treatment:

Diagnostic Test: 18F-PET

Normal renal function

Description:

Patients under examination for prostate cancer

Treatment:

Diagnostic Test: 18F-PET