Trials / Completed
CompletedNCT00874211
S0702: Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid for Bone Metastases
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,571 (actual)
- Sponsor
- SWOG Cancer Research Network · Network
- Sex
- All
- Age
- 120 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Breast Cancer
- Lung Cancer
- Metastatic Cancer
- Multiple Myeloma
- Plasma Cell Neoplasm
- Prostate Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | assessment of therapy complications | By dental and medical assessments. |
Timeline
- Start date
- 2008-12-01
- Primary completion
- 2019-06-01
- Completion
- 2019-06-01
- First posted
- 2009-04-02
- Last updated
- 2019-07-05
Locations
453 sites across 3 countries: United States, Mexico, Saudi Arabia
Source: ClinicalTrials.gov record NCT00874211. Inclusion in this directory is not an endorsement.