title: Randomized, double-blinded, placebo-controlled, trial of risedronate for the prevention of bone mineral density loss in nonmetastatic prostate cancer patients receiving radiation therapy plus androgen deprivation therapy.
abstract: OBJECTIVE
  Androgen deprivation therapy (ADT) has been used as an adjuvant treatment to radiation therapy (RT) for the management of locally advanced prostate carcinoma. Long-term ADT decreases bone mineral density (BMD) and increases the risk of osteoporosis. The objective of this clinical trial was to evaluate the efficacy of risedronate for the prevention of BMD loss in nonmetastatic prostate cancer patients undergoing RT plus 2 to 3 years of ADT.
  
  
  METHODS
  A double-blinded, placebo-controlled, randomized trial was conducted for nonmetastatic prostate cancer patients receiving RT plus 2 to 3 years of ADT. All had T scores > -2.5 on dual energy x-ray absorptiometry at baseline. Patients were randomized 1:1 between risedronate and placebo for 2 years. The primary endpoints were the percent changes in the BMD of the lumbar spine at 1 and 2 years from baseline, measured by dual energy x-ray absorptiometry. Analyses of the changes in BMD and bone turnover biomarkers were carried out by comparing mean values of the intrapatient changes between the 2 arms, using standard t tests.
  
  
  RESULTS
  One hundred four patients were accrued between 2004 and 2007, with 52 in each arm. Mean age was 66.8 and 67.5 years for the placebo and risedronate, respectively. At 1 and 2 years, mean (±SE) BMD of the lumbar spine decreased by 5.77% ± 4.66% and 13.55% ± 6.33%, respectively, in the placebo, compared with 0.12% ± 1.29% at 1 year (P=.2485) and 0.85% ± 1.56% (P=.0583) at 2 years in the risedronate. The placebo had a significant increase in serum bone turnover biomarkers compared with the risedronate.
  
  
  CONCLUSIONS
  Weekly oral risedronate prevented BMD loss at 2 years and resulted in significant suppression of bone turnover biomarkers for 24 months for patients receiving RT plus 2 to 3 years of ADT.
authors.affiliation: Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Choo
authors.forename: Himu
authors.initials: H
authors.lastname: Lukka
authors.forename: Patrick
authors.initials: P
authors.lastname: Cheung
authors.forename: Tom
authors.initials: T
authors.lastname: Corbett
authors.forename: Rosario
authors.initials: R
authors.lastname: Briones-Urbina
authors.forename: Reinhold
authors.initials: R
authors.lastname: Vieth
authors.forename: Lisa
authors.initials: L
authors.lastname: Ehrlich
authors.forename: Alex
authors.initials: A
authors.lastname: Kiss
authors.forename: Cyril
authors.initials: C
authors.lastname: Danjoux
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000009:adverse effects*; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D012968:Etidronic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005269:Femur / Q000187:drug effects / Q000528:radiation effects; D006801:Humans; D008159:Lumbar Vertebrae / Q000187:drug effects / Q000528:radiation effects; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000139:chemically induced / Q000517:prevention & control*; D015990:Placebo Effect; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D000068296:Risedronic Acid
chemical_list: D000726:Androgen Antagonists; D050071:Bone Density Conservation Agents; D000068296:Risedronic Acid; D012968:Etidronic Acid