Bone Quality Evolution in Medication-Related Osteonecrosis of the Jaw Assessed by CBCT (B-ONJ EVOL) (B-ONJ EVOL)

Evolution of Bone Quality in Medication-Related Osteonecrosis of the Jaw: A Retrospective Multicenter Study Using Cone Beam Computed Tomography (CBCT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteonecrosis of the Jaw; Medication-related Osteonecrosis of the Jaw
• Intervention / Treatment: Diagnostic test: Cone Beam Computed Tomography Imaging

Detailed Description

Medication-related osteonecrosis of the jaw (MRONJ) is a serious adverse effect associated with antiresorptive therapies, including bisphosphonates and anti-RANKL monoclonal antibodies. It is characterized by necrotic bone lesions of the jaw, often triggered by dental procedures, and is associated with significant morbidity.

Current imaging evaluation relies primarily on Cone Beam Computed Tomography (CBCT), which is recommended for both diagnosis and follow-up. However, most published studies provide only qualitative or descriptive assessments of bone lesions. Quantitative and longitudinal analyses of bone microarchitecture remain limited.

This retrospective, multicenter, observational study aims to describe the evolution of bone quality in patients with MRONJ managed according to current clinical guidelines.

The primary objective is to evaluate changes in bone mineral density (BMD) measured on CBCT scans at diagnosis and during follow-up.

Secondary objectives include longitudinal assessment of bone morphometric parameters using CBCT imaging and dedicated software (3D Slicer), including:

Bone volume to total volume ratio (BV/TV) Trabecular number (Tb.N) Trabecular separation (Tb.Sp) Hounsfield units (HU), when applicable

Data will be collected retrospectively from clinical records and imaging databases across multiple centers. All data will be pseudonymized prior to analysis.

Statistical analyses will be descriptive. Quantitative variables will be expressed as mean ± standard deviation or median with interquartile range, depending on distribution. Qualitative variables will be presented as frequencies and percentages. Comparisons between subgroups may be performed using appropriate statistical tests (Chi-square or Fisher's exact test for categorical variables, Student's t-test or Mann-Whitney test for continuous variables), with a significance level set at p < 0.05.

The study is conducted in accordance with applicable data protection regulations (MR-004 framework), with minimal risk to participants, as it involves retrospective analysis of existing clinical and imaging data.

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Alexandra Poinas, PhD; Phone Number: +33 2 53 48 28 57; Email: alexandra.poinas@chu-nantes.fr
• Study Contact Backup: Name: Anne-Gaëlle Chaux, MD, PhD; Phone Number: 02 40 08 33 33; Email: annegaelle.chaux@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients With Medication-Related Osteonecrosis of the Jaw; Patients diagnosed with medication-related osteonecrosis of the jaw (MRONJ) included in a retrospective multicenter cohort. Data are collected from clinical records and cone beam computed tomography (CBCT) imaging to assess bone characteristics and disease evolution.	Diagnostic test: Cone Beam Computed Tomography Imaging; Cone 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and up to 24 months
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.	Baseline and up to 24 months
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.	Baseline and up to 24 months
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.	Baseline and up to 24 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Anne-Gaëlle Chaux, MD, PhD, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Bone mineral density; Cone beam computed tomography; Medication-related osteonecrosis of the jaw; Bone morphometry; Trabecular bone; Antiresorptive agents
• Other Study ID Numbers: AP_AGC_SG_B-ONJ-EVOL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No