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

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.

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