Malignant Neoplasm | Genetics in Predicting Risk of Bisphosphonate-Related Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid
Malignant Neoplasm research study
What is the primary objective of this study?
This randomized clinical trial studies genetics in predicting risk of bisphosphonate-related osteonecrosis of the jaw in patients with cancer receiving zoledronic acid. Zoledronic acid is an anti-resorptive drug used as part of cancer treatment. A serious side effect of these drugs is death of the jawbone, commonly called bisphosphonate-related osteonecrosis of the jaw (BRONJ). Genetic research may help doctors understand risk factors for BRONJ or who is more likely to get BRONJ and why.
Who is eligible to participate?
Inclusion Criteria: - PATIENTS WITH BRONJ: - 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: - WHO/ECOG performance score > 2 and life expectancy of < 6 months - 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 - Renal disease, and we will use a calculated serum creatinine clearance over 30 ml/min at the screening appointment as an exclusion criteria - Participation in another research project that might interfere with completion of this study - Patients undergoing active antibiotic therapy
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:zoledronic acidGiven IV
Other:pharmacological studyCorrelative studies
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Arm I (zoledronic acid over 15 minutes)Patients receive zoledronic acid IV over 15 minutes on day 1.
Arm II (zoledronic acid over 30 minutes)Patients receive zoledronic acid IV over 30 minutes on day 1.
Start Date: June 2016
Completed Date: June 2021
Primary Outcome: Plasma concentrations of Zol collected at visits 2, 3, 4, and 5
Secondary Outcome: Identify potential risk factors for BRONJ
Study sponsors, principal investigator, and references
Principal Investigator: Parish Sedghizadeh
Lead Sponsor: University of Southern California
Collaborator: National Cancer Institute (NCI)