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Brief Title: Genetics in Predicting Risk of Bisphosphonate-Related Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid
Official Title: POPULATION PHARMACOMETRICS FOR ASSESSING RISK OF BISPHOSPHONATE-RELATED OSTEONECROSIS OF THE JAW (BRONJ)
Study ID: NCT02069340
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 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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
J.Craig Venter Institute-San Diego, San Diego, California, United States
Name: Parish Sedghizadeh
Affiliation: University of Southern California
Role: PRINCIPAL_INVESTIGATOR