Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs

ConditionsOsteonecrosis of the Jaw Osteonecrosis Due to Drugs, Jaw Osteonecrosis Due to Drug Bisphosphonate-Associated Osteonecrosis Bisphosphonate-Associated Osteonecrosis of the Jaw

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorCatholic University of the Sacred Heart

About this trial

The objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws (MRONJ) in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up. Secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of MRONJ and to identify any systemic as well as local risk factors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with specific prescription to initiate therapy with antiresorptive drugs

Disqualifiers

Previous Head and Neck Radiotherapy

Trial population

Patients starting an antiresorptive drug

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Dental management
Procedure/Surgery
The oral conditions of the included patients will be evaluated at baseline. When indicated, dental extractions will be performed before the beginning of Antiresorptive Therapy. Patients will then receive a six-months intervals follow-up, during which primary and secondary prevention of dental diseases will be performed.

Treatment groups

126 Participants

are divided into 1 treatment group

Group A: Antiresorptive Drugs1 intervention

Trial outcomes

Primary outcomes

Medication Related OsteoNecrosis of the Jaws

Incidence of Medication Related OsteoNecrosis of the Jaws

Time frame

Five years after the beginning of AR therapy

Sponsors and contacts

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Catholic University of the Sacred Heart

Lead sponsor

Source ClinicalTrials.gov

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