Clinical trial · Interventional
Genetics in Predicting Risk of Bisphosphonate-Related Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid
POPULATION PHARMACOMETRICS FOR ASSESSING RISK OF BISPHOSPHONATE-RELATED OSTEONECROSIS OF THE JAW (BRONJ)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Musculoskeletal Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pharmacological study | Other | — | UNRESOLVED |
| zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (zoledronic acid over 15 minutes)
- description
- Patients receive zoledronic acid IV over 15 minutes on day 1.
- interventionNames
- Drug: zoledronic acid
- Other: pharmacological study
- type
- EXPERIMENTAL
- label
- Arm II (zoledronic acid over 30 minutes)
- description
- Patients receive zoledronic acid IV over 30 minutes on day 1.
- interventionNames
- Drug: zoledronic acid
- Other: pharmacological study
Primary outcomes (3)
- measure
- Plasma concentrations of Zol collected at visits 2, 3, 4, and 5
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available