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NCT Number: NCT03716128

Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-PET

Diagnostic Test

Bone biopsy and 18F-PET

Other names: Bone biopsy

Primary outcomes

  1. Can 18F-PET-CT describe bone formation rate?

    Time frame: The bone biopsy and 18F-PET will be performed during two month for each participant

    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

  2. Can non-oxidized PTH describe bone formation rate?

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

    The relation between non-oxidized PTH in ng/L and bone turnover in bone biopsy described as bone formation rate

Secondary outcomes

  1. Can 18F-PET-CT describe mineral apposition rate?

    Time frame: The bone biopsy and 18F-PET will be performed during two month for each participant

    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

  2. Can non-oxidized PTH describe mineral apposition rate?

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

    The relation between non-oxidized PTH in ng/L and bone turnover in bone biopsy described as mineral apposition rate

Study contacts

Contact information is provided by the study sponsor or research team.

Ditte Hansen, PhD

CONTACT

[email protected]

+4538683868

Sponsors and collaborators

Lead sponsor

Ditte Hansen

Other

Collaborators

  • Universiteit Antwerpen
  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Oct 23, 2018
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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