Breast Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

3571

Study ID:

NCT00874211

Recruitment Status:

Completed

Sponsor:

Southwest Oncology Group

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Study is for people with:

Breast Cancer

Estimated Enrollment:

3571

Study ID:

NCT00874211

Recruitment Status:

Completed

Sponsor:


Southwest Oncology Group

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