Genetics in Predicting Risk of Bisphosphonate-Related Osteonecrosis of the Jaw in Patients With C… (NCT02069340) | Clinical Trial Compass
WithdrawnNot Applicable
Genetics in Predicting Risk of Bisphosphonate-Related Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid
United States0Started 2016-06
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* Cogn…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma concentrations of Zol collected at visits 2, 3, 4, and 5
Timeframe: Up to 1 month
2
Urine concentrations of Zol collected at visits 2, 3, 4, and 5
Timeframe: Up to 1 month
3
Jawbone tissue concentrations of Zol collected during surgical treatment for BRONJ