Genetics in Predicting Risk of Bisphosphonate-Related Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid

• Status: Withdrawn
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Collaborator: National Cancer Institute (NCI)
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

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