Medication-related Osteonecrosis of the Jaw (MRONJ)NCT07691892
Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the Jaw
An observational study of Medication-related Osteonecrosis of the Jaw (MRONJ), run by Hospital of Stomatology, Wuhan University.
Trial summary
This prospective observational cohort study aims to develop and evaluate an early warning and risk prediction model for medication-related osteonecrosis of the jaw (MRONJ) based on multimodal data fusion. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Medication-related Osteonecrosis of the Jaw (MRONJ)
- How many people
- 310 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Sep 2030
- How long will I take part?
- 12 Months
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at risk of medication-related osteonecrosis of the jaw will be prospectively recruited from the School \& Hospital of Stomatology, Wuhan University. Eligible participants will include adults with a history of antiresorptive or antiangiogenic medication exposure who require oral and maxillofacial evaluation, dental treatment, or follow-up. Clinical, imaging, laboratory, and follow-up data will be collected to develop and evaluate an early warning and risk prediction model for medication-related osteonecrosis of the jaw.
Who may be able to join
- Adults aged 18 to 70 years, regardless of sex.
- Currently receiving bone-modifying agents, including bisphosphonates or denosumab, for osteoporosis or bone metastases.
- Continuous use of bone-modifying agents for at least 24 months before enrollment.
- Scheduled to undergo clinically indicated invasive oral procedures, including root canal therapy, periapical surgery, tooth extraction, periodontal scaling and root planing, periodontal surgery, or other invasive oral procedures as clinically needed.
- No clinical signs of medication-related osteonecrosis of the jaw before the planned oral procedure, according to the diagnostic criteria of the American Association of Oral and Maxillofacial Surgeons.
- Able to understand the study purpose and procedures and willing to provide written informed consent.
Who cannot join
- Previously diagnosed or suspected medication-related osteonecrosis of the jaw.
- Other diseases or conditions that may cause osteonecrosis of the jaw, such as osteoradionecrosis or malignant tumors of the jaw.
- Severe coagulation disorders or active bleeding disorders that preclude invasive oral procedures.
- Severe cardiac, hepatic, or renal dysfunction, including New York Heart Association class III-IV heart failure, Child-Pugh class C liver disease, or renal failure requiring dialysis.
- Autoimmune disease or current immunosuppressive therapy that may affect bone metabolism or immune status assessment.
- Salivary gland dysfunction, such as Sjögren's syndrome, that may affect the quality of saliva sample collection.
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- Pregnancy or breastfeeding.
- Psychiatric disorders or cognitive impairment that would prevent understanding of the study procedures or compliance with follow-up.
- Uncontrolled hypertension or diabetes mellitus, or a history of stroke or transient ischemic attack within the past 6 months.
- Use of any vaccine for the prevention of infectious diseases, such as influenza or varicella vaccine, within 4 weeks before enrollment.
- Congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis B or hepatitis C infection. Active hepatitis B is defined as HBV DNA above the upper limit of normal, and active hepatitis C is defined as HCV viral titer or RNA above the upper limit of normal.
- Participation in another clinical study that may interfere with the results of this study.
About this study
Official title: Development and Validation of a Multimodal Risk Prediction Model for Medication-Related Osteonecrosis of the Jaw: A Prospective Cohort Study.
This prospective observational cohort study aims to develop and evaluate an early warning and risk prediction model for medication-related osteonecrosis of the jaw (MRONJ) based on multimodal data fusion.
Eligible participants will include adults who have received bone-modifying agents, including bisphosphonates or denosumab, for at least 24 months for osteoporosis or bone metastases and who are scheduled to undergo clinically indicated invasive oral procedures. The study will not assign any treatment or intervention. All oral procedures will be performed as part of routine clinical care.
Read more
Clinical characteristics, medication exposure, oral examination findings, cone-beam computed tomography imaging data, and biological samples including saliva, blood, urine, and gingival crevicular fluid will be collected. Proteomic and metabolomic analyses will be performed to identify candidate biomarkers associated with MRONJ risk.
Participants will be followed prospectively after the oral procedure to assess wound healing, clinical symptoms, imaging changes, and the occurrence of MRONJ. The study will evaluate whether a multimodal model combining clinical, imaging, and biological data can predict the risk of MRONJ after invasive oral procedures.
- Keywords
- medication-related osteonecrosis of the jaw (MRONJ), Bone-modifying agents, Bisphosphonates, Denosumab, Invasive oral procedures, Risk prediction, Multimodal data fusion, Proteomics, Metabolomics, Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MRONJ risk cohort | Participants at risk of medication-related osteonecrosis of the jaw will be prospectively enrolled and followed to evaluate multimodal predictors for early warning and risk prediction of MRONJ. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of medication-related osteonecrosis of the jaw within 12 months after the invasive oral procedure.
The occurrence of medication-related osteonecrosis of the jaw will be assessed according to the diagnostic criteria of the American Association of Oral and Maxillofacial Surgeons. Clinical examination and cone-beam computed tomography will be used to determine whether participants develop medication-related osteonecrosis of the jaw during follow-up.
Measured: 12 months after the invasive oral procedure.
Secondary outcomes (3)
Area under the receiver operating characteristic curve of the multimodal prediction model for medication-related osteonecrosis of the jaw.
The area under the receiver operating characteristic curve (AUC) will be used to evaluate the discrimination performance of a multimodal early warning and risk prediction model for medication-related osteonecrosis of the jaw. The model will integrate clinical characteristics, medication exposure, oral examination findings, cone-beam computed tomography imaging features, and proteomic and metabolomic biomarkers from body fluid samples.
Measured: 3 months, 6 months, 12 months after the invasive oral procedure.
Sensitivity and specificity of the multimodal prediction model for medication-related osteonecrosis of the jaw.
Sensitivity and specificity will be calculated as the proportion of participants who do not develop medication-related osteonecrosis of the jaw and are correctly classified as low risk by the multimodal prediction model.
Measured: 3 months, 6 months, 12 months after the invasive oral procedure.
Early clinical manifestations and progression patterns of medication-related osteonecrosis of the jaw.
Early clinical manifestations and progression patterns will be assessed based on wound healing, pain, swelling, suppuration, numbness, bone exposure, fistula formation, and cone-beam computed tomography findings during follow-up.
Measured: 1 week, 2 weeks, 4 weeks, 3 months, 6 months, and 12 months after the invasive oral procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2030 (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 Jaw (MRONJ)Studies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 310 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hospital of Stomatology, Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingxin Zhu, Hospital of Stomatology, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691892
- Sponsor's protocol ID
- WDKQ2026B51
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Multimodal Risk Prediction Model for Medication-Related Osteonecrosis of the Jaw: A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT07691892
- Acronym / sponsor ID
- WDKQ2026B51
- Keywords
- medication-related osteonecrosis of the jaw (MRONJ), Bone-modifying agents, Bisphosphonates, Denosumab, Invasive oral procedures, Risk prediction, Multimodal data fusion, Proteomics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Hospital of Stomatology, Wuhan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 9 Jul 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.
This prospective observational cohort study aims to develop and evaluate an early warning and risk prediction model for medication-related osteonecrosis of the jaw (MRONJ) based on multimodal data fusion.
Eligible participants will include adults who have received bone-modifying agents, including bisphosphonates or denosumab, for at least 24 months for osteoporosis or bone metastases and who are scheduled to undergo clinically indicated invasive oral procedures. The study will not assign any treatment or intervention. All oral procedures will be performed as part of routine clinical care.
Clinical characteristics, medication exposure, oral examination findings, cone-beam computed tomography imaging data, and biological samples including saliva, blood, urine, and gingival crevicular fluid will be collected. Proteomic and metabolomic analyses will be performed to identify candidate biomarkers associated with MRONJ risk.
Participants will be followed prospectively after the oral procedure to assess wound healing, clinical symptoms, imaging changes, and the occurrence of MRONJ. The study will evaluate whether a multimodal model combining clinical, imaging, and biological data can predict the risk of MRONJ after invasive oral procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRONJ risk cohort | – | –Participants at risk of medication-related osteonecrosis of the jaw will be prospectively enrolled and followed to evaluate multimodal predictors for early warning and risk prediction of MRONJ. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at risk of medication-related osteonecrosis of the jaw will be prospectively recruited from the School \& Hospital of Stomatology, Wuhan University. Eligible participants will include adults with a history of antiresorptive or antiangiogenic medication exposure who require oral and maxillofacial evaluation, dental treatment, or follow-up. Clinical, imaging, laboratory, and follow-up data will be collected to develop and evaluate an early warning and risk prediction model for medication-related osteonecrosis of the jaw.
Key inclusion criteria (6 listed)
- Adults aged 18 to 70 years, regardless of sex.
- Currently receiving bone-modifying agents, including bisphosphonates or denosumab, for osteoporosis or bone metastases.
- Continuous use of bone-modifying agents for at least 24 months before enrollment.
- Scheduled to undergo clinically indicated invasive oral procedures, including root canal therapy, periapical surgery, tooth extraction, periodontal scaling and root planing, periodontal surgery, or other invasive oral procedures as clinically needed.
- No clinical signs of medication-related osteonecrosis of the jaw before the planned oral procedure, according to the diagnostic criteria of the American Association of Oral and Maxillofacial Surgeons.
Key exclusion criteria (12 listed)
- Previously diagnosed or suspected medication-related osteonecrosis of the jaw.
- Other diseases or conditions that may cause osteonecrosis of the jaw, such as osteoradionecrosis or malignant tumors of the jaw.
- Severe coagulation disorders or active bleeding disorders that preclude invasive oral procedures.
- Severe cardiac, hepatic, or renal dysfunction, including New York Heart Association class III-IV heart failure, Child-Pugh class C liver disease, or renal failure requiring dialysis.
- Autoimmune disease or current immunosuppressive therapy that may affect bone metabolism or immune status assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of medication-related osteonecrosis of the jaw within 12 months after the invasive oral procedure.
Time frame: 12 months after the invasive oral procedure.
The occurrence of medication-related osteonecrosis of the jaw will be assessed according to the diagnostic criteria of the American Association of Oral and Maxillofacial Surgeons. Clinical examination and cone-beam computed tomography will be used to determine whether participants develop medication-related osteonecrosis of the jaw during follow-up.
3 secondary outcomes
Area under the receiver operating characteristic curve of the multimodal prediction model for medication-related osteonecrosis of the jaw.
Time frame: 3 months, 6 months, 12 months after the invasive oral procedure.
Sensitivity and specificity of the multimodal prediction model for medication-related osteonecrosis of the jaw.
Time frame: 3 months, 6 months, 12 months after the invasive oral procedure.
Early clinical manifestations and progression patterns of medication-related osteonecrosis of the jaw.
Time frame: 1 week, 2 weeks, 4 weeks, 3 months, 6 months, and 12 months after the invasive oral procedure.
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 9 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication-related Osteonecrosis of the Jaw (MRONJ), run by Hospital of Stomatology, Wuhan University.
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 6 inclusion and 12 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 9 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of medication-related osteonecrosis of the jaw within 12 months after the invasive oral procedure. (time frame: 12 months after the invasive oral procedure.). 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 9 Jul 2026.