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



Status:Archived
Conditions:Breast Cancer, Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011

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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)


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.



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Norwalk, Connecticut 06856
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Providence, RI
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111 Colchester Ave
Burlington, Vermont 05401
(802) 847-0000
Fletcher Allen Health Care As Vermont’s University Medical Center, we at Fletcher Allen are committed...
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Burlington, VT
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Denver, Colorado 80218
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Denver, CO
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Pittsburgh, PA
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Richmond, Virginia 23230
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Richmond, VA
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Salt Lake City, Utah 84112
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Salt Lake City, UT
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West Hollywood, California 90069
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West Hollywood, CA
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