Chronic Kidney Disease and Bone - Correlation Between 18F-PET-TT Imaging and Histomorphometry of Bone in CKD Patients
CKD-Bone
1 other identifier
interventional
90
1 country
1
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 diagnosis of mineral bone disorder and the underlying bone histology in CKD patients is challenging. The treatment of renal osteodystrophy (ROD) and especially the treatment of fractures in this patient group, depends on the underlying bone histopathology and bone turnover. The gold standard for diagnosing the subtypes of ROD is bone biopsy, but it is invasive and requires considerable expertise regarding quantitative histomorphometry and interpretation. Plasma parathormone (PTH) measurement is commonly used to evaluate these patients, and generally extremely high or low PTH levels predict the underlying bone disorder. Still PTHs ability to correctly estimate turnover in bone is limited. Several biomarkers such as tartrate-resistant acid phosphatase 5b (TRAP5b) and procollagen type 1 N-terminal propetide (PINP) has been investigated, but no biomarker in clinical use has yet been proven suitable or superior to PTH to estimate overall bone histology. 18F-NaF positron emission tomography (18F-NaF PET) is a noninvasive quantitative imaging technique that allows assessment of regional bone turnover at clinically relevant sites. 18F-NaF is a bone-seeking tracer, which reflects remodeling of bone and osteoblast activity25. 18F-NaF serves as an efficient tracer to measure metabolic changes in bone. A correlation between histomorphometric markers such as bone formation rate (BFR) and tracer activity in the 18F- NaF PET scan in CKD patients has previously been shown in one small study. This study's goal is to evaluate, if 18-NaF-Positron emission tomography-computed tomography (18F-PET-TT) can be used in the assessment of CKD patients. The hypothesis is that 18F-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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2016
CompletedFirst Posted
Study publicly available on registry
November 17, 2016
CompletedStudy Start
First participant enrolled
December 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMay 13, 2020
May 1, 2020
5 years
September 22, 2016
May 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Evidence of kidney patients adynamic or hyperdynamic bone disease assessed by 18F-PET-TT
18F-PET correlates with histomorphometric markers in bone biopsy
3 years
Study Arms (1)
18F-PET-TT
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Patients with severely decreased kidney function (eGRF below 20ml/min) with secondary hyperparathyroidism. In addition a group of healthy volunteers.
You may not qualify if:
- Pregnancy, parathyroidectomy, biphosphonate-medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
TYKS/nefrologia ja dialyysihoidot
Turku, Finland
Related Publications (1)
Aaltonen L, Koivuviita N, Seppanen M, Kroger H, Tong X, Loyttyniemi E, Metsarinne K. Association between bone mineral metabolism and vascular calcification in end-stage renal disease. BMC Nephrol. 2022 Jan 3;23(1):12. doi: 10.1186/s12882-021-02652-z.
PMID: 34979983DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kaj Metsärinne, LT
Senior physician /TYKS - nefrologia ja dialyysihoidot
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2016
First Posted
November 17, 2016
Study Start
December 17, 2016
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
May 13, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share