Trials / Withdrawn
WithdrawnNCT02069340
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)
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Southern California · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed description
PRIMARY OBJECTIVES: I. To develop a pharmacometric model to predict jawbone zoledronic acid (Zol) concentrations in oncologic patients by conducting a prospective cohort study of Zol pharmacometrics in BRONJ patients, measuring drug in plasma, urine, and jawbone tissue obtained during surgical treatment for BRONJ. SECONDARY OBJECTIVES: I. To clinically assess and validate our predictive pharmacometric model, and develop a risk model for BRONJ in oncologic patients receiving intravenous Zol. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive zoledronic acid intravenously (IV) over 15 minutes on day 1. ARM II: Patients receive zoledronic acid IV over 30 minutes on day 1. After completion of study treatment, patients are followed up for 1 month.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | zoledronic acid | Given IV |
| OTHER | pharmacological study | Correlative studies |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2020-12-01
- Completion
- 2021-06-01
- First posted
- 2014-02-24
- Last updated
- 2017-04-11
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02069340. Inclusion in this directory is not an endorsement.