Finding studies
Finding studies
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Lead
University of Southern California
With
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.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted