Medication-related Osteonecrosis of the Jaw (MRONJ) Registry

Status unconfirmed

Conditions studied: Medication-related Osteonecrosis of the Jaw, Bisphosphonate-Associated Osteonecrosis of the Jaw

In brief

Approximately 500 patients will be included in this patient registry. Data collection includes demographics, clinical data of underlying disease and use of bisphosphonates, denosumab and antiangiogenic drugs , degree and extension of osteonecrosis, osteonecrosis-specific treatment, outcomes and complications within 1 year after treatment.

Key facts

Study ID

NCT02932501

Run by

AO Clinical Investigation and Publishing Documentation

People needed

518

Starts

2017-08-14

Expected to finish

2024-04-01

Last updated by the study team

2024-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• Newly diagnosed patients with osteonecrosis in a facial bone other than the jaw, or
• Newly diagnosed patients with non-exposed MRONJ (stage 0), or
• Newly diagnosed patients with exposed MRONJ, i.e:
• Current or previous treatment with antiresorptive or antiangiogenic agents.
• Exposed bone or bone that can be probed through an intraoral or extraoral fistula(e) in the maxillofacial region that has persisted for more than 8 weeks
• No history of radiation therapy to the jaws or obvious metastatic diseases of the jaw
• Ability to understand the content of the patient information/ Informed Consent Form
• Willingness and ability to participate in the clinical investigation according to the Registry Plan (RP)
• Signed and dated IRB/EC-approved written informed consent
• Mental capacity to comply with post-operative regimen, evaluation and data collection

You may not qualify if…

• Recent history of substance abuse (i. e., recreational drugs, alcohol) that would preclude reliable assessment
• Pregnancy or women planning to conceive within the registry period
• Prisoner
• Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry

Where it is running

• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
• Helsinki University Hospital — Helsinki, Finland
• Charité - Universitätsmedizin Berlin — Berlin, Germany
• Universitätskliniken Eppendorf — Hamburg, Germany
• Ludwig-Maximilians University Munich, Klinik und Poliklinik für Mund-, Kiefer und Gesichtschirurgie — München, Germany
• Eramus MC — Rotterdam, Netherlands
• Hamad Medical Corporation — Doha, Qatar
• Emergency Clinical County Hospital of Constanta — Constanța, Romania
• University Medical Centre Ljubljana — Ljubljana, Slovenia
• Kyungpool National University — Daegu, South Korea
• 12 de Octubre University Hospital — Madrid, Spain
• Universitätsspital Basel — Basel, Switzerland
• Luzerner Kantonsspital — Lucerne, Switzerland
• Universitätsspital Zürich — Zurich, Switzerland

Full record on ClinicalTrials.gov

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