Clinical Trial: Genetics in Predicting Risk of Bisphosphonate-Related Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: POPULATION PHARMACOMETRICS FOR ASSESSING RISK OF BISPHOSPHONATE-RELATED OSTEONECROSIS OF THE JAW (BRONJ)
Brief 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 Summary:
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.
Sponsor: University of Southern California
Current Primary Outcome:
- Plasma concentrations of Zol collected at visits 2, 3, 4, and 5 [ Time Frame: Up to 1 month ]Data will be iteratively fit to the model using non-parametric modeling, simulation, and clinical dosing software. The parameters will be estimated, as well as their relationships to each other. Each measured patient concentration is Fisher weighted.
- Urine concentrations of Zol collected at visits 2, 3, 4, and 5 [ Time Frame: Up to 1 month ]Data will be iteratively fit to the model using non-parametric modeling, simulation, and clinical dosing software. The parameters will be estimated, as well as their relationships to each other. Each measured patient concentration is Fisher weighted.
- Jawbone tissue concentrations of Zol collected during surgical treatment for BRONJ [ Time Frame: Up to 1 month ]Data will be iteratively fit to the model using non-parametric modeling, simulation, and clinical dosing software. The parameters will be estimated, as well as their relationships to each other. Each measured patient concentration is Fisher weighted.
Original Primary Outcome: Same as current
Current Secondary Outcome: Identify potential risk factors for BRONJ [ Time Frame: Up to1 month ]
Original Secondary Outcome: Same as current
Information By: University of Southern California
Dates:
Date Received: February 7, 2014
Date Started: June 2016
Date Completion: June 2021
Last Updated: April 9, 2017
Last Verified: April 2017