Spots Global Cancer Trial Database for Study of Zoledronic Acid Administered Monthly Versus Every 3 Months in Multiple Myeloma and Breast Cancer Patients Who Were Treated With Zoledronic Acid the Prior Year
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Trial Identification
Brief Title: Study of Zoledronic Acid Administered Monthly Versus Every 3 Months in Multiple Myeloma and Breast Cancer Patients Who Were Treated With Zoledronic Acid the Prior Year
Official Title: A Stratified, Randomized, Open-label, Multi-center Comparative 2-arm Trial of PK, PD, and Safety of Zoledronic Acid Infusions Administered Monthly vs. Every 3-month, in Multiple Myeloma Patients With Malignant Bone Lesions, and Breast Cancer Patients With Bone Metastasis, Who Have Received 9-12* Doses of Zoledronic Acid Over the Prior Year. (*Amendment 1 Changed the Required Doses to 9-20 But Due to FDA Guidelines, the Title Has Not Been Changed)
Study ID: NCT00424983
Interventions
Study Description
Brief Summary: The primary objective of this study is to investigate the repeat-dose pharmacokinetic (PK) profile of zoledronic acid when administered every 4 weeks versus every 12 weeks, in patients treated with 9-20 infusions of zoledronic acid during the previous 10-15 months.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Oncotherapeutics, West Hollywood, California, United States
Rocky Mountain Cancer Centers RMCC, Greenwood Village, Colorado, United States
Norwalk Hospital, Norwalk, Connecticut, United States
Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Huntsman Cancer Institute Univ. of Utah, Salt Lake City, Utah, United States
University of Vermont Fletcher Allen Health Care, Burlington, Vermont, United States
Virginia Cancer Institute Virginia Cancer Center, Richmond, Virginia, United States
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Name: Novartis
Affiliation: Novartis
Role: STUDY_CHAIR
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