Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function

Last updated: March 14, 2025
Sponsor: Ditte Hansen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nephropathy

Hyperparathyroidism

Parathyroid Disorders

Treatment

18F-PET

Clinical Study ID

NCT03716128
H-17040409
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

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

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: 18F-PET
Phase:
Study Start date:
September 26, 2018
Estimated Completion Date:
October 31, 2027

Study 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

Connect with a study center

  • Herlev Hospital

    Herlev, 2730
    Denmark

    Active - Recruiting

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