Osteonecrosis of the Jaw (ONJ) Case Registry

Study Overview
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Brief Summary
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Osteonecrosis of the Jaw (ONJ) Case Registry

Detailed Description
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The purpose of the ONJ case registry is to describe the natural history of positively-adjudicated ONJ in subjects with cancer with an observation period of 5 years. Most of these subjects are expected to have received bone antiresorptive agents such as bisphosphonates or denosumab together with cancer-specific therapies (eg, chemotherapy, steroids, or anti-angiogenics). It is also possible that the registry will include subjects with cancer who developed ONJ without exposure to any antiresorptive therapy.

Official Title
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Osteonecrosis of the Jaw (ONJ) Case Registry

Conditions
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Osteonecrosis of the Jaw

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (≥18 years of age) with diagnosis of cancer Newly diagnosed, positively-adjudicated ONJ ECOG <=2 and expected survival ≥3 months Willing to provide access to previous and future medical and dental information Subject or subject's legally acceptable representative has provided written informed consent Exclusion Criteria: History of radiation to the jaws administered for the treatment of cancer Subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge. Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.

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 |
| --- | --- |
| Subjects with cancer and ONJ<br>Subjects with cancer and positively adjudicated ONJ | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution rate and time to ONJ resolution | Resolution: complete coverage of the exposed bone by mucosa in the absence of clinical symptoms Improvement: a decrease in the stage or severity of the lesion Progression: an increase in the stage or severity of the lesion Stable: not resolved, improved, or progressed | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical features of ONJ, including severity and staging at enrollment |  | 5 years | 
| The frequency of risk factors for incident ONJ | Characterize the frequency of risk factors for incident ONJ such as a history of inflammatory dental disease (periodontal and dental abscesses), dentoalveolar procedures, smoking, use of antiangiogenic agents, and duration/dosing regimens of antiresorptive medications prior to the development of ONJ | 5 years | 
| Therapeutic treatment patterns for ONJ | Characterize treatment patterns of antiresorptive medications subsequent to incident ONJ such as the proportion of subjects who continue to be treated with antiresorptive medications by specific agents and ONJ severity and stage | 5 years | 
| Treatment patterns of antiresorptive agents subsequent to incident ONJ | Characterize subsequent treatment patterns for ONJ including antimicrobial oral rinses, antibiotics, and surgery | 5 years |