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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- SWOG Cancer Research Network
- Enrollment
- 3571
- Locations
- 451
- Primary Endpoint
- Diagnosis of confirmed osteonecrosis of the jaw (ONJ)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Diagnosis of confirmed osteonecrosis of the jaw (ONJ)
Time Frame: 3 years
Secondary Outcomes
- Clinical presentation and natural history of ONJ(3 years)
- Disease-specific estimates of the confirmed cumulative incidence at 3 years of ONJ(3 years)
- Association between patient-related outcomes and confirmed incidence(3 years)
- Overall and disease-specific cumulative incidence(3 years)
- Association of baseline factors with cumulative incidence of confirmed ONJ(3 years)