This trial is active, not recruiting.

Conditions breast cancer, lung cancer, metastatic cancer, multiple myeloma, plasma cell neoplasm, prostate cancer, unspecified adult solid tumor, protocol specific
Treatment assessment of therapy complications
Sponsor Southwest Oncology Group
Collaborator National Cancer Institute (NCI)
Start date December 2008
End date July 2017
Trial size 3500 participants
Trial identifier NCT00874211, S0702, U10CA037429


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Patients will be observed and will undergo assessment of therapy complications.
assessment of therapy complications
By dental and medical assessments.

Primary Outcomes

Diagnosis of confirmed osteonecrosis of the jaw (ONJ)
time frame: 3 years

Secondary Outcomes

Disease-specific estimates of the confirmed cumulative incidence at 3 years of ONJ
time frame: 3 years
Clinical presentation and natural history of ONJ
time frame: 3 years
Overall and disease-specific cumulative incidence
time frame: 3 years
Association of baseline factors with cumulative incidence of confirmed ONJ
time frame: 3 years
Association between patient-related outcomes and confirmed incidence
time frame: 3 years

Eligibility Criteria

Male or female participants up to 120 years old.

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

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Southwest Oncology Group.