Medication-related Osteonecrosis of the JawB-ONJ EVOLNCT07588269
Bone Quality Evolution in Medication-Related Osteonecrosis of the Jaw Assessed by CBCT (B-ONJ EVOL)
An observational study of Medication-related Osteonecrosis of the Jaw and Osteonecrosis of the Jaw, run by Nantes University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication-related Osteonecrosis of the Jaw, Osteonecrosis of the Jaw
- What is being tested?
- Cone Beam Computed Tomography Imaging
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Cone Beam Computed Tomography Imaging
- Keywords
- Medication-related osteonecrosis of the jaw, Cone beam computed tomography, Bone mineral density, Bone morphometry, Trabecular bone, Antiresorptive agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone Beam Computed Tomography ImagingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Cone Beam Computed Tomography Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and up to 24 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study startJan 2027 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication-related Osteonecrosis of the JawStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Gaëlle Chaux, MD, PhD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588269
- Sponsor's protocol ID
- AP_AGC_SG_B-ONJ-EVOL
- Acronym
- B-ONJ EVOL
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Bone Quality in Medication-Related Osteonecrosis of the Jaw: A Retrospective Multicenter Study Using Cone Beam Computed Tomography (CBCT)
- ClinicalTrials.gov ID
- NCT07588269
- Acronym / sponsor ID
- B-ONJ EVOL / AP_AGC_SG_B-ONJ-EVOL
- Keywords
- Medication-related osteonecrosis of the jaw, Cone beam computed tomography, Bone mineral density, Bone morphometry, Trabecular bone, Antiresorptive agents
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Medication-Related Osteonecrosis of the Jaw | – | Diagnostic Test: Cone Beam Computed Tomography ImagingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cone Beam Computed Tomography ImagingCone 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. | Diagnostic test | Patients With Medication-Related Osteonecrosis of the Jaw |
Primary outcome
Bone Mineral Density Measured on Cone Beam Computed Tomography
Time frame: Baseline and up to 24 months
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.
4 secondary outcomes
Trabecular Bone Separation Measured on Cone Beam Computed Tomography
Time frame: Baseline and up to 24 months
Bone Volume to Total Volume Ratio Measured on Cone Beam Computed Tomography
Time frame: Baseline and up to 24 months
Trabecular Bone Number Measured on Cone Beam Computed Tomography
Time frame: Baseline and up to 24 months
Hounsfield Unit Values Measured on Cone Beam Computed Tomography
Time frame: Baseline and up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Medication-related Osteonecrosis of the Jaw
Not yet recruiting
Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw
Osteonecrosis of the Jaw
Not yet recruiting
Autologous Platelet Concentrates on the Healing of Extraction Sockets
Medication-related Osteonecrosis of the Jaw
Recruiting
Comparing Implant Retention Versus Removal for MRONJ at Implant Sites
Medication Related Osteonecrosis of the Jaw
Active, not recruiting
Topical Oxygen Therapy for BRONJ
Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ), Oxygen
Not yet recruitingObservational study
Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the Jaw
Medication-related Osteonecrosis of the Jaw (MRONJ)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne-Gaëlle Chaux, MD, PhD principal investigator
Nantes University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Medication-related Osteonecrosis of the Jaw and Osteonecrosis of the Jaw, run by Nantes University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne-Gaëlle Chaux, MD, PhD (02 40 08 33 33, annegaelle.chaux@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density Measured on Cone Beam Computed Tomography (time frame: Baseline and up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.