Medication-related Osteonecrosis of the Jaw (MRONJ) Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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Approximately 500 patients diagnosed with medication-related osteonecrosis of the jaw will be enrolled in the study. Patients will undergo standard (routine) of care treatment, either conservative or surgical or both, and followed up during one year after the initiation of the treatment. Treatment outcome (development of the condition), pain and complications will be collected and documented over the duration of the registry.

Official Title
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International, Multicenter, Prospective Registry to Collect Data of Treatment Patterns of Patients With Medication-related Osteonecrosis of the Jaw (MRONJ) and Their Outcome

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

Intervention / Treatment
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* Procedure: Conservative treatment
* Procedure: Surgical treatment
* Procedure: Adjuvant non-surgical treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MRONJ<br>Patients diagnosed of medication-related osteonecrosis of the jaw (MRONJ). Treatment strategies vary depending on the stage of MRONJ and can be of different nature as: Conservative treatment Surgical treatment Adjuvant non-surgical treatment | Procedure: Conservative treatment<br>* Disinfectant mouth rinses, Antibiotic therapy, Antifungal therapy<br>Procedure: Surgical treatment<br>* Superficial debridement, Complete removal of necrotic bone, Complete bone resection, When applicable revision and soft tissue coverage<br>Procedure: Adjuvant non-surgical treatment<br>* Hyperbaric oxygen therapy Pentoxifylline and tocopherol Ozone therapy Low level laser therapy Pain relief Anti-inflammatory treatment Platelet rich plasma Parathyroid hormone and teriparatide Bone morphogenetic protein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment outcome | Compared to the baseline status of the patient's condition, the outcome will be evaluated as: Worsening of the osteonecrosis (e.g. size of the lesion increased) No change of the osteonecrosis Reduction of the osteonecrosis (e.g. size of the lesion decrease) Complete mucosa healing | 6 months / 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perception | Numeric Rating Scale | 6 months / 1 year | 
| Staging of osteonecrosis | Staging of osteonecrosis according to the American Association of Oral and Maxillofacial Surgeons | 6 months / 1 year | 
| Site and size of the lesion | Site (single vs. multiple) and size of the lesion according to Weitzman et al. | 6 months / 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Jaw, Bisphosphonate, Osteonecrosis, Antiresorptive drugs, Denosumab