title: Prevention of bone loss in survivors of breast cancer: A randomized, double-blind, placebo-controlled clinical trial.
abstract: BACKGROUND
  Few data are available on the safety and efficacy of once-weekly oral bisphosphonate therapy in breast cancer survivors.
  
  
  OBJECTIVE
  Our objective was to determine whether risedronate, 35 mg weekly, is efficacious and safe in preventing bone loss associated with chemotherapy-induced menopause.
  
  
  METHODS
  The study was a randomized, double-blind, placebo-controlled clinical trial over 12 months.
  
  
  METHODS
  Participants included 87 newly postmenopausal women with status post chemotherapy, recruited from a breast cancer clinic in an academic medical center.
  
  
  METHODS
  Participants were randomly assigned to receive risedronate 35 mg/wk or placebo.
  
  
  METHODS
  The primary outcomes were the 12-month changes in spine and hip bone mineral density. Secondary outcomes included changes in markers of bone resorption (urine N-telopeptide cross-linked collagen type I) and formation (osteocalcin, N-terminal propeptide of type I procollagen, and bone-specific alkaline phosphatase).
  
  
  RESULTS
  After 12 months, bone mineral density increased by 1.2% at the spine and 1.3% at the hip in women on risedronate vs. significant decreases for women in the placebo group of 0.9% at the spine and 0.8% at the hip (P < 0.01, difference between groups). N-telopeptide cross-linked collagen type I, a marker of bone resorption, decreased by 19.3%, and N-terminal propeptide of type I procollagen, a marker of bone formation, decreased by 26.6% in participants on active therapy compared with increases in the control group. Risedronate was well tolerated, and the retention rate was 95% at 1 yr.
  
  
  CONCLUSIONS
  Risedronate once weekly prevented bone loss and reduced bone turnover in women with breast cancer treated with chemotherapy. Early measures to prevent bone loss should be considered in this cohort of breast cancer survivors.
authors.affiliation: Department of Medicine, University of Pittsburgh, 3471 Fifth Avenue, Suite 1110, Pittsburgh, Pennsylvania 15213-3221, USA. greenspans@dom.pitt.edu
authors.forename: Susan L
authors.initials: SL
authors.lastname: Greenspan
authors.forename: Rajib K
authors.initials: RK
authors.lastname: Bhattacharya
authors.forename: Susan M
authors.initials: SM
authors.lastname: Sereika
authors.forename: Adam
authors.initials: A
authors.lastname: Brufsky
authors.forename: Victor G
authors.initials: VG
authors.lastname: Vogel
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects; D015519:Bone Density / Q000187:drug effects; D016723:Bone Remodeling / Q000187:drug effects; D001943:Breast Neoplasms / Q000150:complications* / Q000188:drug therapy; D004311:Double-Blind Method; D012968:Etidronic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control*; D000068296:Risedronic Acid
chemical_list: D000970:Antineoplastic Agents; D000068296:Risedronic Acid; D012968:Etidronic Acid