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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

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Trial Conditions
  • Breast Cancer
  • Lung Cancer
  • Metastatic Cancer
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Multiple Myeloma
  • Plasma Cell Neoplasm
  • Prostate Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
What is the purpose of this trial?

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.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
0 and older

Gender:
Both

Eligibility

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

Gender: Both
Steward Physician(s)
  • Catherine Van Poznak, MD
  • Julie R. Gralow, MD
Facilities
  • Holy Family Hospital - Active, not recruiting
Trial Interventions
Procedure
  • assessment of therapy complications
Physician Researcher

Investigator Name:

  • Catherine Van Poznak, MD
  • Julie R. Gralow, MD

Other Information

Sponsor: Southwest Oncology Group
Phase: N/A
Trial ID: NCT00874211
Volunteers:  Not Accepting Healthy Volunteers

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