title: A double-blinded head-to-head trial of minodronate and alendronate in women with postmenopausal osteoporosis.
abstract: BACKGROUND
  In a randomized, active-controlled, double-blinded, multicenter study, the efficacy and safety of minodronate were examined and compared to that of alendronate.
  
  
  METHODS
  A total of 270 postmenopausal osteoporotic women >or=45 years of age were randomized into the minodronate group (n=135) or alendronate group (n=135). Each subject received 1 mg minodronate or 5 mg alendronate once a day for 12 months.
  
  
  RESULTS
  Both treatment groups showed similar changes in BMD after 12 months. After 1 year of treatment, the lumbar spine BMD increased by 5.86% and 6.29% in the minodronate and alendronate groups, respectively, and the total hip BMD increased by 3.47% and 3.27%, respectively. Bone turnover markers were rapidly reduced within 1 month in both treatment groups. Urine DPD was significantly lower in the minodronate group than in the alendronate group at 6 months, and urine NTX was significantly lower in the minodronate group than in the alendronate group at 1 and 9 months. Both completion rates for the 12-month study and the overall incidence of clinical adverse events, including gastrointestinal events, were similar between the two groups.
  
  
  CONCLUSIONS
  The effects on lumbar and hip BMD and the safety profile of minodronate are comparable to those of alendronate. Minodronate is a promising new potent bisphosphonate for the treatment of osteoporosis.
authors.affiliation: Rehabilitation Division and School of Health Science, Tottori University, Yonago, Tottori 683-8504, Japan. hagino@med.tottori-u.ac.jp
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Hagino
authors.forename: Yoshiki
authors.initials: Y
authors.lastname: Nishizawa
authors.forename: Teruki
authors.initials: T
authors.lastname: Sone
authors.forename: Hirotoshi
authors.initials: H
authors.lastname: Morii
authors.forename: Yuji
authors.initials: Y
authors.lastname: Taketani
authors.forename: Toshitaka
authors.initials: T
authors.lastname: Nakamura
authors.forename: Akira
authors.initials: A
authors.lastname: Itabashi
authors.forename: Hideaki
authors.initials: H
authors.lastname: Mizunuma
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Masataka
authors.initials: M
authors.lastname: Shiraki
authors.forename: Toshiomi
authors.initials: T
authors.lastname: Minamide
authors.forename: Toshio
authors.initials: T
authors.lastname: Matsumoto
mesh_terms: D000368:Aged; D019386:Alendronate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015519:Bone Density / Q000502:physiology; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D004164:Diphosphonates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; C087958:YM 529; D019386:Alendronate