S0702: Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid for Bone Metastases
|ClinicalTrials.gov Identifier: NCT00874211|
Recruitment Status : Active, not recruiting
First Posted : April 2, 2009
Last Update Posted : February 2, 2018
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Lung Cancer Metastatic Cancer Multiple Myeloma Plasma Cell Neoplasm Prostate Cancer Unspecified Adult Solid Tumor, Protocol Specific||Procedure: assessment of therapy complications|
- 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.
- 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|
|Estimated Enrollment :||3500 participants|
|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|
|Study Start Date :||December 2008|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Patients will be observed and will undergo assessment of therapy complications.
Procedure: assessment of therapy complications
By dental and medical assessments.
- 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 ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874211
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|Study Chair:||Catherine Van Poznak, MD||University of Michigan Cancer Center|
|Study Chair:||Julie R. Gralow, MD||Seattle Cancer Care Alliance|