Prospective Observational Multicenter Cohort Study to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients with Bone Metastases Starting Zoledronic Acid Treatment
The purpose of this study is to learn how often osteonecrosis of the jaw (ONJ) occurs in patients who are being treated with zoledronic acid during a 3 year time period after starting treatment. This study will also identify risk factors associated with ONJ. Participants in this study have been diagnosed with cancer with bone metastases (cancer that has spread to the bone) and are planning to receive zoledronic acid as part of treatment. Zoledronic acid falls under a category of drugs called bisphosphonates. Bisphosphonates are a type of drug that inhibit cells in the bone called osteoclasts. Osteoclast inhibitors are sometimes given to patients who have cancer that has spread to their bones because it can lower the chances of getting fractures and reduces bone pain. Usually, zoledronic acid is well tolerated by patients, but there has been an increase in the number of reported cases of ONJ. Symptoms associated with ONJ are swelling of the soft tissue around the jaw, infection, loosening of teeth, drainage, and exposed jaw bone.
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