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.
Study Type
OBSERVATIONAL
Enrollment
3,571
By dental and medical assessments.
Regional Medical Center
Anniston, Alabama, United States
Providence Cancer Center at Providence Hospital
Mobile, Alabama, United States
Providence Cancer Center
Anchorage, Alaska, United States
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
NEA Medical Clinic - East Matthews
Jonesboro, Arkansas, United States
Diagnosis of confirmed osteonecrosis of the jaw (ONJ)
Time frame: 3 years
Disease-specific estimates of the confirmed cumulative incidence at 3 years of ONJ
Time frame: 3 years
Clinical presentation and natural history of ONJ
Time frame: 3 years
Overall and disease-specific cumulative incidence
Time frame: 3 years
Association of baseline factors with cumulative incidence of confirmed ONJ
Time frame: 3 years
Association between patient-related outcomes and confirmed incidence
Time frame: 3 years
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