Status:
COMPLETED
S0702: Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid for Bone Metastases
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Novartis
Conditions:
Breast Cancer
Lung Cancer
Eligibility:
All Genders
Up to 120 years
Brief 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...
Detailed 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. Seco...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
3571 Patients enrolled
Trial Details
Trial ID
NCT00874211
Start Date
December 1 2008
End Date
June 1 2019
Last Update
July 5 2019
Active Locations (453)
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1
Regional Medical Center
Anniston, Alabama, United States, 36207
2
Providence Cancer Center at Providence Hospital
Mobile, Alabama, United States, 36608
3
Providence Cancer Center
Anchorage, Alaska, United States, 99508
4
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, United States, 99701