Bone Quality Evolution in Medication-Related Osteonecrosis of the Jaw Assessed by CBCT (B-ONJ EVOL)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital
About this trial
Medication-related osteonecrosis of the jaw (MRONJ) is a known complication of antiresorptive therapies such as bisphosphonates and denosumab. It can lead to bone damage in the jaw, with variable clinical outcomes depending on disease stage and management.
Cone Beam Computed Tomography (CBCT) is currently recommended for diagnosis and follow-up of MRONJ. However, most studies rely on qualitative or descriptive imaging findings, and little is known about how bone quality evolves over time using quantitative imaging parameters.
This retrospective multicenter study aims to describe the evolution of bone quality in patients with MRONJ using CBCT imaging. Bone parameters such as bone mineral density and trabecular structure will be measured at diagnosis and during follow-up.
The study will help improve understanding of bone changes over time in MRONJ and may contribute to better assessment and management of the disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient aged 18 years or older
Diagnosis of medication-related osteonecrosis of the jaw (MRONJ), stage 0, 1, or 2
Available diagnostic CBCT and at least 2 follow-up cone beam computed tomography (CBCT) examinations
Able to understand the study information and not opposed to participation
Disqualifiers
Other jaw bone disease
History of cervicofacial irradiation
Stage 3 medication-related osteonecrosis of the jaw
Fewer than 2 follow-up cone beam computed tomography (CBCT) examinations
Trial population
Adult patients with medication-related osteonecrosis of the jaw identified retrospectively from clinical and imaging records at participating French hospital centers, including CHU de Nantes, Centre Léon Bérard, CHU de Nancy/Centre Oscar Lambret, and AP-HP Pitié-Salpêtrière.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Cone Beam Computed Tomography Imaging
Diagnostic testCone beam computed tomography (CBCT) imaging is used to assess bone mineral density, trabecular structure, and morphometric characteristics of the jaw in patients with medication-related osteonecrosis of the jaw. Imaging data are retrospectively analyzed without any additional procedure performed for research purposes.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Patients With Medication-Related Osteonecrosis of the Jaw1 intervention
Trial outcomes
Primary outcomes
1
Bone Mineral Density Measured on Cone Beam Computed Tomography
Bone mineral density assessed on cone beam computed tomography (CBCT) scans at diagnosis and on follow-up scans during clinical management of medication-related osteonecrosis of the jaw. Higher values indicate greater bone mineral density.
Time frame
Baseline and up to 24 monthsSecondary outcomes
1
Trabecular Bone Separation Measured on Cone Beam Computed Tomography
Trabecular bone separation (Tb.Sp), expressed in millimeters, measured on cone beam computed tomography (CBCT) scans using 3D Slicer software at diagnosis and during follow-up. Higher values indicate greater trabecular separation.
Time frame
Baseline and up to 24 months2
Bone Volume to Total Volume Ratio Measured on Cone Beam Computed Tomography
Bone volume to total volume ratio (BV/TV), expressed as a percentage, measured on cone beam computed tomography (CBCT) scans using 3D Slicer software at diagnosis and during follow-up. Higher values indicate a greater proportion of bone volume.
Time frame
Baseline and up to 24 months3
Trabecular Bone Number Measured on Cone Beam Computed Tomography
Trabecular bone number (Tb.N), expressed in mm-¹, measured on cone beam computed tomography (CBCT) scans using 3D Slicer software at diagnosis and during follow-up. Higher values indicate a greater number of trabeculae.
Time frame
Baseline and up to 24 months4
Hounsfield Unit Values Measured on Cone Beam Computed Tomography
Hounsfield unit (HU) values measured on cone beam computed tomography (CBCT) scans using 3D Slicer software, when applicable, at diagnosis and during follow-up. Higher values indicate greater radiologic density.
Time frame
Baseline and up to 24 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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