Clinical Trial

Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the Jaw

Not Yet Recruiting
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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. 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.
Trial Details
NCT Number NCT07691892
Lead Sponsor Hospital of Stomatology, Wuhan University
Conditions Medication-related Osteonecrosis of the Jaw (MRONJ)
Enrollment 310 participants
Start Date 2026-08-01
Primary Completion 2029-09-01 (estimated)
Study Completion 2030-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-09