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S0702: Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid for Bone Metastases

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Novartis
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00874211
First received: April 1, 2009
Last updated: February 10, 2014
Last verified: February 2014

April 1, 2009
February 10, 2014
December 2008
April 2015   (final data collection date for primary outcome measure)
Diagnosis of confirmed osteonecrosis of the jaw (ONJ) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Diagnosis of confirmed osteonecrosis of the jaw (ONJ) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00874211 on ClinicalTrials.gov Archive Site
  • Disease-specific estimates of the confirmed cumulative incidence at 3 years of ONJ [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Clinical presentation and natural history of ONJ [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall and disease-specific cumulative incidence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Association of baseline factors with cumulative incidence of confirmed ONJ [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Association between patient-related outcomes and confirmed incidence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Disease-specific estimates of the confirmed cumulative incidence at 3 years of ONJ [ Designated as safety issue: No ]
  • Clinical presentation and natural history of ONJ [ Designated as safety issue: No ]
  • Overall and disease-specific cumulative incidence [ Designated as safety issue: No ]
  • Association of baseline factors with cumulative incidence of confirmed ONJ [ Designated as safety issue: No ]
  • Association between patient-related outcomes and confirmed incidence [ Designated as safety issue: No ]
Not Provided
Not Provided
 
S0702: Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid for Bone Metastases
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

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.

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.

Secondary

  • 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum for banking & whole blood for DNA analysis and banking.

Non-Probability Sample

SWOG membership and CCOP participants through CTSU.

  • Breast Cancer
  • Lung Cancer
  • Metastatic Cancer
  • Multiple Myeloma
  • Plasma Cell Neoplasm
  • Prostate Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
Procedure: assessment of therapy complications
By dental and medical assessments.
Observation
Patients will be observed and will undergo assessment of therapy complications.
Intervention: Procedure: assessment of therapy complications
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3500
April 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Mexico,   Saudi Arabia
 
NCT00874211
CDR0000611929, S0702, U10CA037429
Yes
Southwest Oncology Group
Southwest Oncology Group
  • National Cancer Institute (NCI)
  • Novartis
Study Chair: Catherine Van Poznak, MD University of Michigan Cancer Center
Study Chair: Julie R. Gralow, MD Seattle Cancer Care Alliance
Southwest Oncology Group
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP