An observational study in Medication-related Osteonecrosis of the Jaw and Osteonecrosis of the Jaw, sponsored by Nantes University Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Nantes University Hospital · Observational
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.
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.
Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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 months
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 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and up to 24 months
No study locations are listed for this record.
Plan to share: Undecided
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Nantes University Hospital