Overview

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Withdrawn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