The Use of Zoledronic Acid in Men Receiving Androgen Deprivation Therapy for Prostate Cancer With Severe Osteopenia or Osteoporosis
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This investigator-initiated study was supported by a grant from Novartis Pharmaceutical Corporation, East Hanover, NJ.
The protocol design, study conduct, results review, statistical analysis, and protocol monitoring were conducted independently by the Cooperative Studies Coordinating Center, Hines, IL. The study medication was provided by Novartis Pharmaceuticals Corporation and distributed by the Cooperative Studies Clinical Research Pharmacy Coordinating Center, Albuquerque, NM.
Organizational members of the Zoledronic Acid Trial (The use of zoledronic acid in men on androgen deprivation therapy for prostate cancer with preexisting osteoporosis”) were as follows: Principal investigators (Grant and Protocol development), Steven C. Campbell and Nirmala Bhoopalam; Co-Principal investigator (Grant and Protocol development), H. Garewal; Site Investigators, Steven C. Campbell and N. Bhoopalam (Hines, IL.), P. VanVeldhuizen (Kansas City, MO), P. Iyer (Long Beach, CA), A. Arcenas (Washington, DC), C. Vera (Boston, MA), H Gareval (Tucson, AZ); Cooperative Studies Coordinating Center, Hines, IL (Design, management, monitoring, and analysis of the study), Domenic J. Reda, Thomas E. Moritz, Nancy K. Ellis, Lizy Thottapurathu, Mazen Abdellatif, Jan Motyka; DXA central review, Nicholas Friedman (Hines, IL); Cooperative Studies Clinical Research Pharmacy Coordinating Center (Albuquerque, NM) (distribution of study drug and placebo), Stuart Warren, Jolene Day; Clinical Coordinator, Regina Chorley (Hines, IL.); Site Coordinators, I. Makar (Hines, IL), K. Gomes (Kansas City, MO), C. Kaneshiro (Long Beach, CA); Executive Committee, N. Bhoopalam (Chair), S. Campbell, H. Garewal, N. Friedman, M. Terris, D. J. Reda, S. Warren, T. E. Moritz, R. Chorley, N. K. Ellis, L. Lacerna (Novartis representation); Data Monitoring Board, R. Adler (Chair), M. Gong, G. McCabe, M. Spaulding.
Participating VA hospitals: Hines VA Medical center, Hines, IL; VA Long Beach Health Care System, Long Beach, CA; Kansas City VA, Kansas City, MO; Southern Arizona VA Health Care System, Tucson, AZ; Washington, DC VA Medical Center, Washington, DC; VA Boston Healthcare System, Jamaica Plain Division, Boston, MA.
PII: S0090-4295(10)00045-2
doi:10.1016/j.urology.2009.11.083
© 2010 Elsevier Inc. All rights reserved.
