title: Osteoporosis prevention in prostate cancer patients receiving androgen ablation therapy: placebo-controlled double-blind study of estradiol and risedronate: N01C8.
abstract: OBJECTIVE
  The purpose of this study is to test the ability of risedronate and estradiol, alone or in combination, to prevent bone loss associated with androgen deprivation therapy in men with prostate cancer.
  
  
  METHODS
  This is a randomized placebo-controlled trial of risedronate and estradiol, alone or in combination, in men with prostate cancer receiving androgen deprivation therapy. The primary outcome was change in hip bone mineral density at 1 year.
  
  
  RESULTS
  No statistical difference was found among the groups for bone mineral density changes. The only side effects of note were increased gynecomastia and breast tenderness associated with estrogen therapy. The study was limited by poor accrual and subsequent lack of statistical power.
  
  
  CONCLUSIONS
  Men receiving androgen deprivation therapy for prostate cancer are at risk for bone loss and should receive appropriate bone density monitoring and preventive advice about calcium, vitamin D, exercise, and fall prevention. Prescription drugs proven in this patient population should be used when the risk of fracture is high.
authors.affiliation: Mayo Clinic Rochester, 200 First Street, SW, Rochester, MN 55905, USA.
authors.forename: Ann E
authors.initials: AE
authors.lastname: Kearns
authors.forename: Donald W
authors.initials: DW
authors.lastname: Northfelt
authors.forename: Amylou C
authors.initials: AC
authors.lastname: Dueck
authors.forename: Pamela J
authors.initials: PJ
authors.lastname: Atherton
authors.forename: Shaker R
authors.initials: SR
authors.lastname: Dakhil
authors.forename: Kendrith M
authors.initials: KM
authors.lastname: Rowland
authors.forename: Jyotsna
authors.initials: J
authors.lastname: Fuloria
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Flynn
authors.forename: Todor
authors.initials: T
authors.lastname: Dentchev
authors.forename: Charles L
authors.initials: CL
authors.lastname: Loprinzi
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004958:Estradiol / Q000627:therapeutic use*; D012968:Etidronic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists; D006177:Gynecomastia / Q000139:chemically induced; D006801:Humans; D008297:Male; D010024:Osteoporosis / Q000139:chemically induced* / Q000517:prevention & control*; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D000068296:Risedronic Acid
chemical_list: D050071:Bone Density Conservation Agents; D007987:Gonadotropin-Releasing Hormone; D004958:Estradiol; D000068296:Risedronic Acid; D012968:Etidronic Acid