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Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716128
Recruitment Status : Unknown
Verified August 2019 by Ditte Hansen, Herlev Hospital.
Recruitment status was:  Recruiting
First Posted : October 23, 2018
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
University of Copenhagen
Universiteit Antwerpen
Information provided by (Responsible Party):
Ditte Hansen, Herlev Hospital

Study Description
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Brief 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

Condition or disease Intervention/treatment
Renal Osteodystrophy 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 Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function Can 18F-PET Replace Bone Histomorphometry
Actual Study Start Date : September 26, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Kidney Tests

Groups and Cohorts
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Group/Cohort Intervention/treatment
Low turnover bone disease
PTH<150 pg/ml
 Diagnostic Test: 18F-PET
Bone biopsy and 18F-PET
Other Name: Bone biopsy
High turnover bone disease
PTH>300 pg/ml
 Diagnostic Test: 18F-PET
Bone biopsy and 18F-PET
Other Name: Bone biopsy
Normal renal function
Patients under examination for prostate cancer
 Diagnostic Test: 18F-PET
Bone biopsy and 18F-PET
Other Name: Bone biopsy


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Bone Biopsy

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716128


Contacts
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Contact: Ditte Hansen, PhD +4538683868 ditte.hansen.04@regionh.dk

Locations
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Denmark
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Ditte Hansen, PhD    +4538683868    ditte.hansen.04@regionh.dk   
Sponsors and Collaborators
Ditte Hansen
University of Copenhagen
Universiteit Antwerpen
More Information
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Responsible Party: Ditte Hansen, Associate professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT03716128    
Other Study ID Numbers: H-17040409
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Kidney Disease-Mineral and Bone Disorder
Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Kidney Diseases
Urologic Diseases
Metabolic Diseases
Calcium Metabolism Disorders
 Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hyperparathyroidism, Secondary
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases