896 A PHASE III, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP, PLACEBO-CONTROLLED STUDY OF ORAL ALEDRONATE, 70 MG ONCE-A-WEEK, FOR THE PREVENTION OF ANDROGEN DEPRIVATION BONE LOSS IN NON-METASTATIC PROSTATE CANCER. A CANADIAN UROLOGY RESEARCH CONSORTIUM STUDY

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You have accessJournal of UrologyProstate Cancer: Advanced1 Apr 2011896 A PHASE III, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP, PLACEBO-CONTROLLED STUDY OF ORAL ALEDRONATE, 70 MG ONCE-A-WEEK, FOR THE PREVENTION OF ANDROGEN DEPRIVATION BONE LOSS IN NON-METASTATIC PROSTATE CANCER. A CANADIAN UROLOGY RESEARCH CONSORTIUM STUDY Laurence Klotz, Irene McNeil, Marlene Kebabdjian, Liying Zhang, and Joseph Chin Laurence KlotzLaurence Klotz Toronto, Canada More articles by this author , Irene McNeilIrene McNeil Toronto, Canada More articles by this author , Marlene KebabdjianMarlene Kebabdjian Toronto, Canada More articles by this author , Liying ZhangLiying Zhang Toronto, Canada More articles by this author , and Joseph ChinJoseph Chin London, Canada More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.2605AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Androgen deprivation therapy (ADT) induces loss of bone mineral density (BMD) and increases the risk of fractures in patients with prostate cancer. We sought to determine whether a weekly dose of alendronate, an oral bisphosphonate, could reduce this unwanted side effect. OBJECTIVE To assess whether once weekly oral alendronate therapy would maintain or improve bone mineral density in men initiating ADT for localized prostate cancer. METHODS In this multi-center, double-blind, randomized, placebo-controlled study, hormonally naïve prostate cancer patients initiating ADT with leuprolide acetate (Lupron®) 30mg intramuscularly every 4 months were randomized to receive either oral alendronate 70 mg once-weekly or placebo for one year. Both groups received daily calcium (equivalent to 500 mg elemental calcium) and vitamin D (400 IU) supplementation daily. Changes in BMD and bone marker levels were assessed. RESULTS There are 167 patients for the primary endpoint, which was the percent change from baseline to end of study in spine BMD. 77 (46%) received alendronate and 90 (54%) received placebo treatment. Treatment has highly significant effect on the percent change in spine BMD after adjusting for center and baseline Spine BMD (p<0.0001). Alendronate increased the BMD at the hip and spine compared with those receiving calcium and vitamin D alone. All measures of bone turnover markers decreased in patients treated with alendronate. The incidence of adverse events was similar in the two treatment groups. CONCLUSIONS This study showed that weekly oral alendronate prevented bone loss and increased bone mass in addition to decreasing bone turnover, with few related side effects. Precent change in Spine BMD: ITT population Treatment N Mean Std Median Min Max Aledronate 77 1.71 4.06 1.88 -11.24 13.55 Placebo 90 -1.89 4.31 -1.68 -19.0 6.22 © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 185Issue 4SApril 2011Page: e359 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Laurence Klotz Toronto, Canada More articles by this author Irene McNeil Toronto, Canada More articles by this author Marlene Kebabdjian Toronto, Canada More articles by this author Liying Zhang Toronto, Canada More articles by this author Joseph Chin London, Canada More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...