Genetics in Predicting Risk of Bisphosphonate-Related Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid
NCT ID: NCT02069340
Last Updated: 2017-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2016-06-30
2021-06-30
Brief Summary
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Detailed Description
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I. To develop a pharmacometric model to predict jawbone zoledronic acid (Zol) concentrations in oncologic patients by conducting a prospective cohort study of Zol pharmacometrics in BRONJ patients, measuring drug in plasma, urine, and jawbone tissue obtained during surgical treatment for BRONJ.
SECONDARY OBJECTIVES:
I. To clinically assess and validate our predictive pharmacometric model, and develop a risk model for BRONJ in oncologic patients receiving intravenous Zol.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive zoledronic acid intravenously (IV) over 15 minutes on day 1.
ARM II: Patients receive zoledronic acid IV over 30 minutes on day 1.
After completion of study treatment, patients are followed up for 1 month.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Arm I (zoledronic acid over 15 minutes)
Patients receive zoledronic acid IV over 15 minutes on day 1.
zoledronic acid
Given IV
pharmacological study
Correlative studies
Arm II (zoledronic acid over 30 minutes)
Patients receive zoledronic acid IV over 30 minutes on day 1.
zoledronic acid
Given IV
pharmacological study
Correlative studies
Interventions
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zoledronic acid
Given IV
pharmacological study
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All cancer patients \> 18 years of any ethnicity who have been treated with intravenous zoledronate (zoledronic acid) for \>=1 year duration
* Clinical diagnosis of BRONJ subsequent to oral surgery as established by standard clinical protocol per American Association of Oral and Maxillofacial Surgeons (AAOMS) diagnostic criteria
* Willingness to have photographs taken to document lesions
* Consent for sample collection for urine, hematology, histopathology and microbial profiling
* Cognitively able and willing to provide consent
* Have a World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance score =\< 2 and life expectancy \> 6 months
* PATIENTS WITHOUT BRONJ:
* Cancer patients without BRONJ who have been treated with intravenous zoledronate for \>= 1 year duration
* No signs or symptoms of BRONJ
* Willingness to provide consent for sample collection for blood, urine and saliva
Exclusion Criteria
* Coagulopathy
* Active systemic infection or autoimmune disease
* Currently pregnant or within 3 months post-partum, or unwilling to undergo pregnancy testing or report possible pregnancy promptly
* Severe cardiovascular, pulmonary or other systemic conditions that prevent participation in the study
* Salivary gland hypofunction regardless of underlying pathology
* Neutropenia (serum absolute neutrophil count \[ANC\] \< 1,000/uL)
* Cognitive, language or hearing problems
* Participation in another research project that might interfere with completion of this study
* Patients undergoing active antibiotic therapy
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Parish Sedghizadeh
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
J.Craig Venter Institute-San Diego
San Diego, California, United States
Countries
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Other Identifiers
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NCI-2014-00207
Identifier Type: REGISTRY
Identifier Source: secondary_id
0S-13-3
Identifier Type: OTHER
Identifier Source: secondary_id
0S-13-3
Identifier Type: -
Identifier Source: org_study_id
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