title: Clinical efficacy and treatment persistence of monthly minodronate for osteoporotic patients unsatisfied with, and shifted from, daily or weekly bisphosphonates: the BP-MUSASHI study.
abstract: This multi-center, prospective, open-label, observational study evaluated the effects of once-monthly minodronate (50 mg) on treatment persistence, bone turnover markers, bone mineral density, low back pain, and upper gastrointestinal symptoms in outpatients with osteoporosis previously treated with daily or weekly bisphosphonate products.
  
  
  BACKGROUND
  The purposes of this study were to investigate the effects of once-monthly oral minodronate (MIN 50 mg) on bone turnover markers and bone mineral density, low back pain, and upper gastrointestinal symptoms, as well as preference for and treatment persistence of MIN 50 mg among Japanese osteoporosis patients currently treated with daily or weekly bisphosphonates.
  
  
  METHODS
  Study patients were allocated based on their preference to either the Switch group (patients willing to switch over to MIN 50 mg) or the Continue group (patients wanting to continue their current therapies). Patients' treatment persistence and satisfaction levels with the therapies were assessed using a self-administered questionnaire. The study endpoints were serum TRACP-5b, serum P1NP, bone mineral density, upper gastrointestinal symptoms, and low back pain.
  
  
  RESULTS
  In total, 264 and 133 patients were allocated into the Switch and Continue groups, respectively. Approximately, 65 % of patients were willing to switch to MIN 50 mg, with the predominant reason being "less frequent dosing more convenient." Treatment persistence was significantly higher in the Switch group (MIN 50 mg) than the Continue group. Almost all patients with abnormal bone metabolism markers demonstrated normalization after switchover. MIN 50 mg alleviated low back pain and upper gastrointestinal symptoms induced by prior bisphosphonate use.
  
  
  CONCLUSIONS
  MIN 50 mg alleviates low back pain, reduces bone turnover markers and increases bone density, and induces fewer upper gastrointestinal symptoms after switchover from prior bisphosphonate products, and therefore, it may provide patients with a more convenient treatment option and enhance long-term treatment persistence.
authors.affiliation: Department of Orthopaedic Surgery, School of Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan, a-sakai@med.uoeh-u.ac.jp.
authors.forename: A
authors.initials: A
authors.lastname: Sakai
authors.forename: S
authors.initials: S
authors.lastname: Ikeda
authors.forename: N
authors.initials: N
authors.lastname: Okimoto
authors.forename: H
authors.initials: H
authors.lastname: Matsumoto
authors.forename: K
authors.initials: K
authors.lastname: Teshima
authors.forename: Y
authors.initials: Y
authors.lastname: Okazaki
authors.forename: F
authors.initials: F
authors.lastname: Fukuda
authors.forename: S
authors.initials: S
authors.lastname: Arita
authors.forename: H
authors.initials: H
authors.lastname: Tsurukami
authors.forename: M
authors.initials: M
authors.lastname: Nagashima
authors.forename: T
authors.initials: T
authors.lastname: Yoshioka
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004164:Diphosphonates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D057915:Drug Substitution; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D017116:Low Back Pain / Q000209:etiology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D057240:Patient Preference; D011446:Prospective Studies; D016896:Treatment Outcome; D016903:Drug Monitoring
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; C087958:YM 529