Document Detail

Intravenous zoledronic acid to prevent osteoporosis in a veteran population with multiple risk factors for bone loss on androgen deprivation therapy.
MedLine Citation:
PMID:  19758618     Owner:  NLM     Status:  MEDLINE    
PURPOSE: Androgen deprivation therapy for prostate cancer is associated with osteoporosis and increased fracture risk. Previous studies of zoledronic acid demonstrated bone loss prevention in patients initiating androgen deprivation therapy. There are limited data on patients on prolonged androgen deprivation therapy or in Veterans Affairs patients with multiple risk factors for osteoporosis. METHODS: We randomized 93 patients with M0 prostate cancer in this placebo controlled trial in the Veterans Affairs health care system. Preplanned strata included 50 patients on androgen deprivation therapy for less than 1 year (stratum 1) and 43 on androgen deprivation therapy for greater than 1 year (stratum 2). In each stratum patients were randomized to 4 mg zoledronic acid intravenously every 3 months for 4 treatments or intravenous placebo. The primary end point was the percent change in bone mineral density at the lumbar spine at 12 months. RESULTS: Age, race, body mass index and osteoporosis risk factors were similar for the 2 treatments. Most patients were former smokers, had moderate alcohol intake, were not on calcium/vitamin D supplements and were relatively sedentary at baseline. In stratum 1 spine bone mineral density increased 5.95% in the zoledronic acid arm and decreased 3.23% in the placebo arm (p = 0.0044). In stratum 2 spine bone mineral density increased 6.08% in the zoledronic acid arm and only increased 1.57% in the placebo arm (p = 0.0005). Treatment was well tolerated with minimal impact on renal function. CONCLUSIONS: Zoledronic acid improved bone mineral density in patients with M0 prostate cancer on androgen deprivation therapy for 1 year or less, or greater than 1 year. This finding indicates that bisphosphonate therapy remains effective when initiated later in the course of androgen deprivation therapy and is efficacious in Veterans Affairs patients with multiple risk factors for osteoporosis.
Nirmala Bhoopalam; Steven C Campbell; Thomas Moritz; William R Broderick; Padmini Iyer; Anthony G Arcenas; Peter J Van Veldhuizen; Nicholas Friedman; Domenic Reda; Stuart Warren; Harinder Garewal
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-09-16
Journal Detail:
Title:  The Journal of urology     Volume:  182     ISSN:  1527-3792     ISO Abbreviation:  J. Urol.     Publication Date:  2009 Nov 
Date Detail:
Created Date:  2009-10-12     Completed Date:  2009-10-30     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0376374     Medline TA:  J Urol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2257-64     Citation Subset:  AIM; IM    
Edward Hines, Jr Veterans Affairs Hospital, Hines, Illinois 60141, USA.
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MeSH Terms
Androgen Antagonists / adverse effects*,  therapeutic use
Bone Density Conservation Agents / administration & dosage*
Diphosphonates / administration & dosage*
Imidazoles / administration & dosage*
Infusions, Intravenous
Osteoporosis / chemically induced*,  prevention & control*
Prostatic Neoplasms / drug therapy
Risk Factors
Reg. No./Substance:
0/Androgen Antagonists; 0/Bone Density Conservation Agents; 0/Diphosphonates; 0/Imidazoles; 118072-93-8/zoledronic acid

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