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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Procedure: assessment of therapy complications


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Participant must have bone metastasis from multiple myeloma, solid tumors, or other malignancy for which intravenous bisphosphonate has clinical indications in the treatment of metastatic bone disease Treatment with osteoclast inhibition is clinically indicated Must be planning to receive zoledronic acid* within the next 30 days NOTE: *Osteoclast inhibition therapy will continue thereafter as clinically indicated. No prior diagnosis of osteonecrosis of the jaw Patients previously treated with osteoclast inhibition therapy are eligible, provided the following criteria apply: Prior osteoclast inhibition for low bone mass (osteoporosis or osteopenia): Patients may have previously received at most 3 doses of osteoclast-inhibiting therapy with denosumab, IV ibandronate, pamidronate, or zoledronic acid for low bone mass (osteopenia or osteoporosis) within 3 years prior to registration Prior oral bisphosphonate therapy at osteoporosis or osteopenia dosing at any time prior to registration is allowed Prior exposures to other medications used to treat low bone mass at osteoporosis or osteopenia dosing are permitted Prior osteoclast inhibition for metastatic bone disease (tumor involving bone): Patients may have previously received osteoclast-inhibiting therapy with denosumab, ibandronate (oral or IV cancer dosing), pamidronate, or zoledronic acid to treat metastatic bone disease within 180 days prior to registration Patients receiving these regimens for metastatic bone disease prior to 180 days before registration are not eligible Prior osteoclast-inhibiting therapy at higher dosing than outlined above at any time prior to registration is not allowed PATIENT CHARACTERISTICS: Zubrod performance status 0-3 Patients who may be acutely ill from spinal cord compromise, hypercalcemia of malignancy, or other process may be study candidates once the acute condition has been addressed and performance status improves to 0-3 Not pregnant or nursing Negative pregnancy test Willing and physically able to comply with study procedures and assessments Willing to provide information on personal history, including tobacco and alcohol use, and pain assessment Willing to provide access to prior and future dental information No other prior malignancy except for any of the following: Adequately treated basal cell carcinoma or squamous cell carcinoma of the skin In situ cervical cancer Adequately treated stage I or II cancer for which the patient is currently in complete remission Any other cancer for which the patient has been disease-free for 5 years PRIOR CONCURRENT THERAPY: See Disease Characteristics No history of radiation to the maxillofacial area administered for therapeutic intent in the treatment of cancer Concurrent participation in other therapeutic and non-therapeutic clinical trials allowed The sum of prior IV bisphosphonate doses must not be greater than 10 The sum of prior denosumab doses must not be greater than 8 The total of both IV bisphosphonate and denosumab used for any indication must not be greater than 12 doses

Ages Eligible for Study
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Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation<br>Patients will be observed and will undergo assessment of therapy complications. | Procedure: assessment of therapy complications<br>* By dental and medical assessments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of confirmed osteonecrosis of the jaw (ONJ) |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-specific estimates of the confirmed cumulative incidence at 3 years of ONJ |  | 3 years | 
| Clinical presentation and natural history of ONJ |  | 3 years | 
| Overall and disease-specific cumulative incidence |  | 3 years | 
| Association of baseline factors with cumulative incidence of confirmed ONJ |  | 3 years | 
| Association between patient-related outcomes and confirmed incidence |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone metastases, unspecified adult solid tumor, protocol specific, refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, male breast cancer, recurrent breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent non-small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer, recurrent small cell lung cancer