S0702: Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid for Bone Metastases

Completed

• Conditions: Multiple Myeloma; Unspecified Adult Solid Tumor, Protocol Specific; Breast Cancer; Metastatic Cancer; Prostate Cancer; Lung Cancer; Plasma Cell Neoplasm

• Registration Number: NCT00874211
• Lead Sponsor: SWOG Cancer Research Network

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-01
• Study First Posted: 2009-04-02
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3571

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis of confirmed osteonecrosis of the jaw (ONJ)	3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (451)

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

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

East Bay Radiation Oncology Center; 🇺🇸 Castro Valley, California, United States

Valley Medical Oncology Consultants - Castro Valley; 🇺🇸 Castro Valley, California, United States

Cancer Care Center at John Muir Health - Concord Campus; 🇺🇸 Concord, California, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

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