Osteonecrosis of the Jaw (ONJ) Case Registry

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.

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.