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Therapeutic Areas: Oncology | Musculoskeletal
Disease Category: Bone Metastases
Location: United States, IL

Clinical Trial Details

Overview

Research Study Summary

SWOG S0702 Prospective Observational Study of the Incidence of Osteonecrosis of the Jaw in Cancer Patients with Bone Metastases Receiving Zoledronic Acid

Purpose

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.

Patient Inclusion 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
  • Zubrod performance status 0-3
  • Treatment with osteoclast inhibition is clinically indicated
  • Willing and physically able to comply with study procedures and assessments
  • Must be planning to receive zoledronic acid* within the next 30 days [Note: *Osteoclast inhibition therapy will continue thereafter as clinically indicated.]
  • Willing and physically able to comply with study procedures and assessments
  • Willing to provide access to prior and future dental information
  • No prior diagnosis of osteonecrosis of the jaw

  • Patients previously treated with osteoclast inhibition therapy are eligible, provided the following criteria apply:
    1. Prior osteoclast inhibition for low bone mass (osteoporosis or osteopenia)
    2. 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
    3. Prior oral bisphosphonate therapy at osteoporosis or osteopenia dosing at any time prior to registration is allowed
    4. Prior exposures to other medications used to treat low bone mass at osteoporosis or osteopenia dosing are permitted
    5. Prior osteoclast inhibition for metastatic bone disease (tumor involving bone)
    6. 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
    7. Patients receiving these regimens for metastatic bone disease prior to 180 days before registration are not eligible
    8. Prior osteoclast-inhibiting therapy at higher dosing than outlined above at any time prior to registration is not allowed

Patient Exclusion Criteria:

  • 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
  • No other prior malignancy except for any of the following:
    1. Adequately treated basal cell carcinoma or squamous cell carcinoma of the skin
    2. In situ cervical cancer
    3. Adequately treated stage I or II cancer for which the patient is currently in complete remission
    4. Any other cancer for which the patient has been disease-free for 5 years

To Learn more
Phase

3

Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Facility Type

N/A

Contact

Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071

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Research Center Information: Sherman Health

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 183113

Date Last Changed: July 17, 2013


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