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

NCT07691892 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 310

Last updated 2026-07-09

No results posted yet for this study

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.

Conditions

  • Medication-related Osteonecrosis of the Jaw (MRONJ)

Sponsors & Collaborators

  • Hospital of Stomatology, Wuhan University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2029-09-01
Completion
2030-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07691892 on ClinicalTrials.gov