Breast Cancer Clinical Trial
Official title:
S0702: A 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
RATIONALE: Gathering information about how often osteonecrosis of the jaw occurs in patients
receiving zoledronic acid for bone metastases may help doctors learn more about the disease
and provide the best follow-up care.
PURPOSE: This clinical trial is studying osteonecrosis of the jaw in patients with cancer who
are receiving zoledronic acid for bone metastases.
OBJECTIVES:
Primary
- To prospectively access the cumulative incidence of osteonecrosis of the jaw (ONJ) at 3
years in cancer patients with bone metastasis receiving zoledronic acid treatment.
Secondary
- To describe the clinical presentation and natural history of ONJ.
- To identify potential risk factors for the development of ONJ.
- To estimate the cumulative incidence of ONJ at 3 years for different tumor types (i.e.,
breast cancer, multiple myeloma, prostate cancer, lung cancer, and other cancers).
- To better define the patient-related outcomes of ONJ.
OUTLINE: This is a multicenter study.
Patients undergo dental assessments at baseline and every 3-6 months for 3 years.
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