Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the Jaw
2 luglio 2026 aggiornato da: Lingxin Zhu, Hospital of Stomatology, Wuhan University
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.
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.
Panoramica dello studio
Stato
Non ancora reclutamento
Tipo di studio
Osservativo
Iscrizione (Stimato)
310
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Incidence of medication-related osteonecrosis of the jaw within 12 months after the invasive oral procedure.
Lasso di tempo: 12 months after the invasive oral procedure.
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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.
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12 months after the invasive oral procedure.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Area under the receiver operating characteristic curve of the multimodal prediction model for medication-related osteonecrosis of the jaw.
Lasso di tempo: 3 months, 6 months, 12 months after the invasive oral procedure.
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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.
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3 months, 6 months, 12 months after the invasive oral procedure.
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Sensitivity and specificity of the multimodal prediction model for medication-related osteonecrosis of the jaw.
Lasso di tempo: 3 months, 6 months, 12 months after the invasive oral procedure.
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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.
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3 months, 6 months, 12 months after the invasive oral procedure.
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Early clinical manifestations and progression patterns of medication-related osteonecrosis of the jaw.
Lasso di tempo: 1 week, 2 weeks, 4 weeks, 3 months, 6 months, and 12 months after the invasive oral procedure.
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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.
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1 week, 2 weeks, 4 weeks, 3 months, 6 months, and 12 months after the invasive oral procedure.
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 agosto 2026
Completamento primario (Stimato)
1 settembre 2029
Completamento dello studio (Stimato)
1 settembre 2030
Date di iscrizione allo studio
Primo inviato
2 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
2 luglio 2026
Primo Inserito (Effettivo)
9 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
9 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 luglio 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- WDKQ2026B51
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .