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Chronic Kidney Disease and Bone - Correlation Between 18F-PET-TT Imaging and Histomorphometry of Bone in CKD Patients (CKD-Bone)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02967042
Recruitment Status : Recruiting
First Posted : November 17, 2016
Last Update Posted : September 18, 2018
Information provided by (Responsible Party):
Turku University Hospital

Brief Summary:

Chronic kidney disease (CKD) is an increasing public health problem and the number of patient with chronic kidney disease is increasing worldwide. Bone abnormalities are found almost universally in patients with CKD requiring dialysis and in the majority of patients with CKD stages 3-5. Chronic kidney disease-mineral bone disorder (CKD-MBD) is a complex disorder of bone and mineral metabolism, which is associated with disorder in circulating levels of hormones and development of secondary hyperparathyroid disease. The abnormalities of mineral homeostasis impair bone remodeling and mineralization and results in cortical and trabecular defects and an increased fracture risk. There is also an association with increased morbidity and mortality. CKD-MBD is also associated with development of calcification of the blood vessels. During the last decade it has been increasingly acknowledged that mineral and bone disorder contribute to the excessively high cardiovascular morbidity and mortality in patients with chronic kidney disease. The pathophysiology behind the disorder varies a lot and can be divided into three groups; high turnover renal bone disease, low-turnover disease and mixed-uremic osteodystrophy. The treatment of CKD-MBD depends of the subtype of the disorder.

The diagnosis of CKD-MBD is still challenging. Biomarkers such as parathyroid hormone (PTH) and alkaline phosphatase (ALP) are used to evaluate bone turnover and formation, but both biomarkers have several limitations and are both unspecific. Many biomarkers have been used in research applications, but yet none of them is in clinical use. Dual X ray absorptiometry (DXA) is used to measure fracture risk in patients with normal kidney function, but is not useful in patients with chronic kidney disease stage 3 - 5. Different imaging techniques have been investigated, but still bone biopsy is the golden standard for diagnosing and classification of the subtypes of CKD-MBD. Bone biopsy is invasive and is not available in every center.

This study`s goal is to evaluate, if 18-Fluor-Positron emission tomography-computed tomography (18F-PET-TT) can be used in the assessment of CKD patients. The hypothesis is that 18-PET-TT correlates with the histomorphometry of bone biopsy and with the calcification score in CKD patients and that 18F-PET-TT maybe can be used as a diagnostic imaging technique in the future.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Device: 18F-PET-TT Not Applicable

Detailed Description:

This is a prospective study which will recruit patients with severely decreased kidney function (eGRF below 20ml/min) and who have secondary hyperparathyroidism. Also patients who have received a renal transplant will be included, if they have hyperparathyroid disease. A control group will be needed to validate the F18-PET-TT method.

The goal is to include 10-20 patients in each group and 10 persons in the control group. Group I: patients in hemodialysis, group II: patients in peritoneal dialysis, group III predialysis patients, group IV: patients with a kidney transplant and group V: healthy controls. Blood tests measuring the bone formation and turnover will be taken during the normal clinical controls of the patients. Echocardiogram, which is reasonable sensitive, is done to detect and evaluate valvular calcification. Bone biopsy is done in the day care unit. To obtain information about dynamic parameters of the bone the patient should have a double labeling of the bone surface, which is achieved by giving tetracycline in two periods. The biopsy is taken in local anesthesia from the anterior iliac spine vertically. Bone biopsy gives the possibility to evaluate the histomorphometry of the bone and to diagnose the subtypes of CKD-MBD.

18F-PET-TT is done within one month from the bone biopsy. PET with the short half-life bone seeking 18F-Sodium Fluoride (18F-NaF), provide an unique way of assessment of regional bone metabolism. 18F-NaF binds to sights of new bone formation and serves as a marker of bone blood flow and osteoblastic activity. A dynamic 18F-PET-TT imaging is first done of the lumbar region of the spine, following with a static PET-TT and also measurement of calcification score using PET-TT. 18F-NaF is injected intravenously by direct venipuncture or intravenous catheter. All the patients are also asked for permission to use DNA-samples if needed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Chronic Kidney Disease and Bone - Correlation Between 18F-PET-TT Imaging and Histomorphometry of Bone in Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism
Study Start Date : August 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
18F-PET-TT Device: 18F-PET-TT
can 18F-PET-TT be used as an diagnostic tool in patients with CKD-MBD

Primary Outcome Measures :
  1. Evidence of kidney patients adynamic or hyperdynamic bone disease assessed by 18F-PET-TT [ Time Frame: 3 years ]
    18F-PET correlates with histomorphometric markers in bone biopsy

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients with severely decreased kidney function (eGRF below 20ml/min) and who have secondary hyperparathyroidism. In addition a group of healthy volunteers.

Exclusion Criteria:

  • Pregnancy, parathyroidectomy, biphosphonate-medication.

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 identifier (NCT number): NCT02967042

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Contact: Louise Aaltonen, LL 023138003
Contact: Niina Koivuviita, LT

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TYKS/nefrologia ja dialyysihoidot Recruiting
Turku, Finland
Contact: Louise Aaltonen, LL    023138003   
Principal Investigator: Louise Aaltonen, LL         
Sponsors and Collaborators
Turku University Hospital
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Study Director: Kaj Metsärinne, LT Senior physician /TYKS - nefrologia ja dialyysihoidot

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Responsible Party: Turku University Hospital Identifier: NCT02967042     History of Changes
Other Study ID Numbers: T239/2016
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency