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

Exclusion Criteria

• •* 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