Chronic Kidney DiseaseCKD-BoneNCT02967042
Chronic Kidney Disease and Bone - Correlation Between 18F-PET-TT Imaging and Histomorphometry of Bone in CKD Patients
A study testing 18F-PET-TT in people with Chronic Kidney Disease, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- 18F-PET-TT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFinland
- Study dates
- 17 Dec 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with severely decreased kidney function (eGRF below 20ml/min) with secondary hyperparathyroidism. In addition a group of healthy volunteers.
Who cannot join
- Pregnancy, parathyroidectomy, biphosphonate-medication.
Trial locations and contacts
1 site in 1 country.
Niina Koivuviita, LT contact
Finland1 site, 1 recruiting
- Recruiting
TYKS/nefrologia ja dialyysihoidot
Turku
Louise Aaltonen, LL, 023138003, louise.aaltonen@tyks.fi
Louise Aaltonen, LL
About this study
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
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.
Read more
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.
Read the detailed description
This is a cross-sectional prospective study. 10 - 20 patients with secondary/tertiary hyprparathyreoidism on oeritoneal dialysis, hemodialysis, predialysis patients and patients, who have received a kidney transplant will be included,. Data collection in the dialysis group is finnished and the first article published (Aaltonen et al, Bone 2020). A control group was recruited for validation of the PET-method.
All participants undergo a 18F-PET-TT scan. 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.
Blood tests measuring the bone formation and turnover will be taken during the normal clinical controls of the patients or at the latest wheb the bone biopsy is takekn. Echocardiogram, which is reasonable sensitive, is done to detect and evaluate valvular calcification. Bone biopsy is done in the day care unit within one month from the PET-scan. To obtain information about dynamic parameters of the bone, the patients had double labeling with tetracycline. The biopsy is taken in local anesthesia from the anterior iliac spine vertically.
- Conditions
- Chronic Kidney Disease
- Being tested
- 18F-PET-TT
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-PET-TTDevice
can 18F-PET-TT be used as an diagnostic tool in patients with CKD-MBD
| Study group | Role | What they receive |
|---|---|---|
| 18F-PET-TT | Other | Not described Receives: Device: 18F-PET-TT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of kidney patients adynamic or hyperdynamic bone disease assessed by 18F-PET-TT
18F-PET correlates with histomorphometric markers in bone biopsy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start17 Dec 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kaj Metsärinne, LT, Study director, Senior physician /TYKS - nefrologia ja dialyysihoidot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967042
- Sponsor's protocol ID
- T239/2016
- Acronym
- CKD-Bone
- Status last verified
- May 2020
- First submitted
- 22 Sep 2016
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34979983
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02967042
- Acronym / sponsor ID
- CKD-Bone / T239/2016
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 17 Dec 2016 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a cross-sectional prospective study. 10 - 20 patients with secondary/tertiary hyprparathyreoidism on oeritoneal dialysis, hemodialysis, predialysis patients and patients, who have received a kidney transplant will be included,. Data collection in the dialysis group is finnished and the first article published (Aaltonen et al, Bone 2020). A control group was recruited for validation of the PET-method.
All participants undergo a 18F-PET-TT scan. 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.
Blood tests measuring the bone formation and turnover will be taken during the normal clinical controls of the patients or at the latest wheb the bone biopsy is takekn. Echocardiogram, which is reasonable sensitive, is done to detect and evaluate valvular calcification. Bone biopsy is done in the day care unit within one month from the PET-scan. To obtain information about dynamic parameters of the bone, the patients had double labeling with tetracycline. The biopsy is taken in local anesthesia from the anterior iliac spine vertically.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-PET-TT | Other | Device: 18F-PET-TT |
Who may qualify
- Ages
- 25 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with severely decreased kidney function (eGRF below 20ml/min) with secondary hyperparathyroidism. In addition a group of healthy volunteers.
Key exclusion criteria (1 listed)
- Pregnancy, parathyroidectomy, biphosphonate-medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-PET-TTcan 18F-PET-TT be used as an diagnostic tool in patients with CKD-MBD | Device | 18F-PET-TT |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Derived from this study: PubMed 34979983Aaltonen 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.
- Correlation between 18F-Sodium Fluoride positron emission tomography and bone histomorphometry in dialysis patientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niina Koivuviita, LT contact
Kaj Metsärinne, LT study director
Senior physician /TYKS - nefrologia ja dialyysihoidot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-PET-TT in people with Chronic Kidney Disease, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louise Aaltonen, LL (023138003, louise.aaltonen@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of kidney patients adynamic or hyperdynamic bone disease assessed by 18F-PET-TT (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02967042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020; AzTrials last refreshed its copy on 31 Oct 2026.