A bone scan in combination with some specific blood samples for the classification of bone disease in patients suffering from chronic kidney disease.

18F-NaF PET/CT in combination with biomarkers for the classification of renal osteodystrophy in chronic kidney disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-005160-34-DK

Enrollment

Registered

2016-12-23

Start date

2017-04-21

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD), especially renal osteodystofi. MedDRA version: 20.0 Level: LLT Classification code 10065404 Term: Combined positron emission tomogram and computerised tomogram System Organ Class: 10022891 - Investigations MedDRA version: 20.0 Level: SOC Classification code 10022891 Term: Investigations

Interventions

Product Name: Sodium Fluoride F 18/ 18F-NaF Pharmaceutical Form: Solution for injection INN or Proposed INN: 18F-NaF CAS Number: 8061-51-6

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 30-80 years Chronic hemodialysis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Medical treatment with systemic corticosteroid Inability to give informed consent Pregnancy and lactation Not radically treated cancer disease Alcohol or drugs abuse Within three months: bone fracture, AMI or TCI, parathyroidektomi or kidney transplantation

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate 18 F-NaF PET/CT in combination with biomarkers for classification of subtypes of renal osteodystrophy in patients treated with hemodialysis. This is compared to the golden standard (bone biopsy with double tetracycline labeling).;Secondary Objective: not applicable;Primary end point(s): SUVmaks (Sandard value uptake) and Ki;Timepoint(s) of evaluation of this end point: At the end of the trial, when all subjects have completed and the blood samples, bone biopsy and PET/CT-scans are analyzed	—

Measure

Time frame

Main Objective: To investigate 18 F-NaF PET/CT in combination with biomarkers for classification of subtypes of renal osteodystrophy in patients treated with hemodialysis. This is compared to the golden standard (bone biopsy with double tetracycline labeling).;Secondary Objective: not applicable;Primary end point(s): SUVmaks (Sandard value uptake) and Ki;Timepoint(s) of evaluation of this end point: At the end of the trial, when all subjects have completed and the blood samples, bone biopsy and PET/CT-scans are analyzed

—

Secondary

Measure	Time frame
Secondary end point(s): Bone biopsy: BFR/BS, Ac.F, O.th, Mlt, BV/TV Biomarkers: bALP, FGF23, osteocalcin, OPG/sRANKL ratio PET/CT: SUVmean, SUVpeak, SUVa50, MAV, total bone volume and calciumscore ;Timepoint(s) of evaluation of this end point: At the end of the trial, when all subjects have completed and the blood samples, bone biopsy and PET/CT-scans are analyzed	—

Countries

Denmark

Contacts

Public ContactMarie Houmaa Vrist

Universitetsklinikken for Nyresygdomme og Blodtryksforhøjelse, Regionshospitalet Holstebro, Hospitalsenheden Vest

marvri@rm.dk004578436585

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026