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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.


Detailed Description
This study is about Zoledronic acid that falls under a category of drugs called bisphosphonates. Bisphosphonates are sometimes given to patients who have cancer that has spread to their bones because it can lower the chances of getting fractures and reduces bone pain. Usually, zoledronic acid is well tolerated by patients, but there has been an increase in the number of reported cases of osteonecrosis of the jaw (ONJ). Symptoms associated with ONJ are swelling of the soft tissue around the jaw, infection, loosening of teeth, drainage, and exposed jaw bone. There is concern about the association of ONJ with bisphosphonate therapy.The primary objective of this study is to prospectively assess, how often ONJ occurs in patients who are being treated with zoledronic acid during a 3 year time period after starting treatment.This is not a treatment study. This study involves collecting information about the treatment with zoledronic acid and collecting information about participants general health and medical history, oral health and dental history and pain assessment through questionnaires.Participants go through some exams, tests or procedures that are part of regular cancer care, like Blood work, Dental exam, Oral x-rays, Medical and dental history, Physical exam.Every six months for up to three years, participants will be asked to provideInformation regarding current treatment for metastatic bone diseaseInformation about any health problems they are havingInformation about their medical history, treatments and physical examInformation regarding their oral health, dental history and exams and pain assessmentIf at any time participants are diagnosed with osteonecrosis of the jaw (ONJ)Every three months for up to three years, they will be asked to provideInformation regarding current treatment for ONJInformation about any health problems they are having with the zoledronic acidInformation regarding oral complications and recent dental proceduresUpdated information on their medical history, physical exam, and treatmentSubmission of dental x-rays and scansThe primary endpoint is the diagnosis of confirmed ONJ. For statistical consideration the goal of this study is to estimate the cumulative incidence rate of confirmed ONJ associated with zoledronic acid at 3 years in patients with bone metastases.About 3,500 people will take part in this study nationally; 200 research participants from USC will take part in this study.



Inclusion and Exclusion Criteria

  • 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


Please contact Maria Brown to learn more about where you can participate in this trial. Please use the contact form on the right side.

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