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

NCT07588269 | Not Yet Recruiting

• 1 other identifier: AP_AGC_SG_B-ONJ-EVOL
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Medication-related Osteonecrosis of the Jaw; Osteonecrosis of the Jaw

Keywords

Medication-related osteonecrosis of the jaw; Cone beam computed tomography; Bone mineral density; Bone morphometry; Trabecular bone; Antiresorptive agents

Outcome Measures

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.

  Baseline and up to 24 months

Secondary Outcomes (4)

• Trabecular Bone Separation Measured on Cone Beam Computed Tomography

  Baseline and up to 24 months

• Bone Volume to Total Volume Ratio Measured on Cone Beam Computed Tomography

  Baseline and up to 24 months

• Trabecular Bone Number Measured on Cone Beam Computed Tomography

  Baseline and up to 24 months

• Hounsfield Unit Values Measured on Cone Beam Computed Tomography

  Baseline and up to 24 months

Study Arms (1)

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

Interventions

Cone Beam Computed Tomography Imaging DIAGNOSTIC_TEST

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.

Patients With Medication-Related Osteonecrosis of the Jaw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Officials

• Anne-Gaëlle Chaux, MD, PhD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Gaëlle Chaux, MD, PhD

CONTACT

02 40 08 33 33; annegaelle.chaux@chu-nantes.fr

Alexandra Poinas, PhD

CONTACT

+33 2 53 48 28 57; alexandra.poinas@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 14, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05