for people ages up to 120 years (full criteria)
at UC Davis
study started
estimated completion



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.

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




  • 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.


  • 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.


Breast CancerLung CancerMetastatic CancerMultiple MyelomaPlasma Cell NeoplasmProstate CancerUnspecified Adult Solid Tumor, Protocol Specificbone metastasesrefractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myelomamale breast cancerrecurrent breast cancerstage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerrecurrent prostate cancerstage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IV prostate cancerrecurrent non-small cell lung cancerstage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerextensive stage small cell lung cancerlimited stage small cell lung cancerrecurrent small cell lung cancerBreast NeoplasmsLung NeoplasmsProstatic NeoplasmsNeoplasms, Plasma CellNeoplasm MetastasisPlasmacytomaOsteonecrosisZoledronic Acidassessment of therapy complications


For people ages up to 120 years


  • 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


  • 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


  • 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


  • University of California Davis Cancer Center
    SacramentoCalifornia95817United States
  • USC/Norris Comprehensive Cancer Center and Hospital
    Los AngelesCalifornia90089-9181United States
  • Epic Care - Oakland
    OaklandCalifornia94612United States
  • St. Joseph Hospital Regional Cancer Center - Orange
    OrangeCalifornia92868United States
  • Alta Bates Summit Medical Center - Summit Campus
    OaklandCalifornia94609United States
  • Bay Area Breast Surgeons, Incorporated
    OaklandCalifornia94609United States
  • CCOP - Bay Area Tumor Institute
    OaklandCalifornia94609United States
  • Larry G Strieff MD Medical Corporation
    OaklandCalifornia94609United States
  • Tom K Lee, Incorporated
    OaklandCalifornia94609United States


in progress, not accepting new patients
Start Date
Completion Date
Southwest Oncology Group
Study Type
Last Updated