Renal OsteodystrophyNCT03716128
Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function
An observational study of Renal Osteodystrophy, run by Ditte Hansen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Osteodystrophy
- What is being tested?
- 18F-PET
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Sep 2018to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- -≥ 18 years
- estimated Glomerular Filtration Rate (eGFR) ≤ 20 ml/min/1,73m2
- PTH < 150 pg/ml or PTH > 300 pg/ml
- -≥ 18 years
- eGFR >= 60 ml/min
- under examination for c prostata
- Prostatic Specific Antigen (PSA) total <40 µg/l
Who cannot join
- ongoing malignancy
- Allergy towards tetracyclin
- Pregnancy
- Control Group:
- Former kidney disease
- ionized calcium or PTH outside normal range
Show all 9Show fewer
- Known metabolic bone disease
- treatment with anticoagulants
- Disturbed thrombosis and hemostasis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Herlev Hospital
Herlev, 2730
Ditte Hansen, PhD, +4538683868, ditte.hansen.04@regionh.dk
About this study
Official title: Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function Can 18F-PET Replace Bone Histomorphometry
The aim of the study is to
- To describe the bone morphology in patients with reduced renal function and high or low parathyroid hormone (PTH) respectively.
- 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
- To investigate if non-oxidized PTH reflects bone turnover
Read the 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
- Conditions
- Renal Osteodystrophy
- Being tested
- 18F-PET
- Medical subject headings
- Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-PETDiagnostic test
Also called Bone biopsy
Bone biopsy and 18F-PET
| Study group | Role | What they receive |
|---|---|---|
| Low turnover bone disease | PTH<150 pg/ml Receives: Diagnostic Test: 18F-PET | |
| High turnover bone disease | PTH>300 pg/ml Receives: Diagnostic Test: 18F-PET | |
| Normal renal function | Patients under examination for prostate cancer Receives: Diagnostic Test: 18F-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Can 18F-PET-CT describe bone formation rate?
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
Measured: The bone biopsy and 18F-PET will be performed during two month for each participant
Can non-oxidized PTH describe bone formation rate?
The relation between non-oxidized PTH in ng/L and bone turnover in bone biopsy described as bone formation rate
Measured: Blood sample and bone biopsy will be performed during two month for each participant
Secondary outcomes (2)
Can 18F-PET-CT describe mineral apposition rate?
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
Measured: The bone biopsy and 18F-PET will be performed during two month for each participant
Can non-oxidized PTH describe mineral apposition rate?
The relation between non-oxidized PTH in ng/L and bone turnover in bone biopsy described as mineral apposition rate
Measured: Blood sample and bone biopsy will be performed during two month for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start26 Sep 2018
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal OsteodystrophyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ditte Hansen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Universiteit Antwerpen
- Responsible party
- Sponsor-investigator, Ditte Hansen, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716128
- Sponsor's protocol ID
- H-17040409
- Status last verified
- Mar 2025
- First submitted
- 26 Sep 2018
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function Can 18F-PET Replace Bone Histomorphometry
- ClinicalTrials.gov ID
- NCT03716128
- Acronym / sponsor ID
- H-17040409
- Conditions
- Renal Osteodystrophy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ditte HansenUniversity, hospital or other
- Collaborators
- University of Copenhagen, Universiteit Antwerpen
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 23 Oct 2018 (actual)
- 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.
The aim of the study is to
- To describe the bone morphology in patients with reduced renal function and high or low parathyroid hormone (PTH) respectively.
- 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
- To investigate if non-oxidized PTH reflects bone turnover
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low turnover bone disease | – | Diagnostic Test: 18F-PETPTH<150 pg/ml |
| High turnover bone disease | – | Diagnostic Test: 18F-PETPTH>300 pg/ml |
| Normal renal function | – | Diagnostic Test: 18F-PETPatients under examination for prostate cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- -≥ 18 years
- estimated Glomerular Filtration Rate (eGFR) ≤ 20 ml/min/1,73m2
- PTH < 150 pg/ml or PTH > 300 pg/ml
- -≥ 18 years
- eGFR >= 60 ml/min
Key exclusion criteria (9 listed)
- ongoing malignancy
- Allergy towards tetracyclin
- Pregnancy
- Former kidney disease
- ionized calcium or PTH outside normal range
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-PETAlso: Bone biopsyBone biopsy and 18F-PET | Diagnostic test | High turnover bone disease, Low turnover bone disease, Normal renal function |
Primary outcome
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
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
2 secondary outcomes
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
Can non-oxidized PTH describe mineral apposition rate?
Time frame: Blood sample and bone biopsy will be performed during two month for each participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Osteodystrophy, run by Ditte Hansen at 1 site in Denmark.
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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 18 Mar 2025. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ditte Hansen, PhD (+4538683868, ditte.hansen.04@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2025.