title: Alendronate once weekly for the prevention and treatment of bone loss in Canadian adult cystic fibrosis patients (CFOS trial).
abstract: BACKGROUND
  Patients with cystic fibrosis (CF) are at risk for early bone loss, and demonstrate increased risks for vertebral fractures and kyphosis. A multicenter, randomized, controlled trial was conducted to assess the efficacy, tolerability, and safety of therapy with oral alendronate (FOSAMAX; Merck; Whitehouse Station, NJ) in adults with CF and low bone mass.
  
  
  METHODS
  Participants received placebo or alendronate, 70 mg once weekly, for 12 months. All participants received 800 IU of vitamin D and 1,000 mg of calcium daily. Adults with confirmed CF with a bone mineral density (BMD) T score of < - 1.0 were eligible for inclusion. Participants who had undergone organ transplantation or had other reported contraindications were excluded from the study. The primary outcome measure was the mean (+/- SD) percentage change in lumbar spine BMD after 12 months. Secondary measures included the percentage change in total hip BMD, the number of new vertebral fractures (grade 1 or 2), and changes in quality of life.
  
  
  RESULTS
  A total of 56 participants were enrolled in the study (mean age, 29.1 +/- 8.78 years; 61% male). The absolute percentage changes in lumbar spine and total hip BMDs at follow-up were significantly higher in the alendronate therapy group (5.20 +/- 3.67% and 2.14 +/- 3.32%, respectively) than those in the control group (- 0.08 +/- 3.93% and - 1.3 +/- 2.70%, respectively; p < 0.001). At follow-up, two participants (both in the control group) had a new vertebral fracture (not significant), and there were no differences in quality of life or the number of adverse events (including serious and GI-related events).
  
  
  CONCLUSIONS
  Alendronate therapy was well tolerated and produced a significantly greater increase in BMD over 12 months compared with placebo.
authors.affiliation: Department of Medicine, McMaster University, Hamilton, ON, Canada. Electronic address: papaioannou@hhsc.ca.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Papaioannou
authors.affiliation: Department of Medicine, McMaster University, Hamilton, ON, Canada.
authors.forename: Courtney C
authors.initials: CC
authors.lastname: Kennedy
authors.affiliation: Department of Medicine, McMaster University, Hamilton, ON, Canada.
authors.forename: Andreas
authors.initials: A
authors.lastname: Freitag
authors.affiliation: Department of Medicine, McMaster University, Hamilton, ON, Canada.
authors.forename: George
authors.initials: G
authors.lastname: Ioannidis
authors.affiliation: Department of Medicine, McMaster University, Hamilton, ON, Canada.
authors.forename: John
authors.initials: J
authors.lastname: O'Neill
authors.affiliation: Department of Nuclear Medicine, Hamilton Health Sciences, Hamilton, ON, Canada.
authors.forename: Colin
authors.initials: C
authors.lastname: Webber
authors.affiliation: Department of Diagnostic Imaging, Scarborough Hospital, Scarborough, ON, Canada.
authors.forename: Margaret
authors.initials: M
authors.lastname: Pui
authors.affiliation: Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.
authors.forename: Yves
authors.initials: Y
authors.lastname: Berthiaume
authors.affiliation: Adult Cystic Fibrosis Clinic, University of Calgary Medical Clinic of the Foothills Medical Center, Calgary, AB, Canada.
authors.forename: Harvey R
authors.initials: HR
authors.lastname: Rabin
authors.affiliation: Schulich School of Medicine and Dentistry, University of Western Ontario, London Health Science Centre, London, ON, Canada.
authors.forename: Nigel
authors.initials: N
authors.lastname: Paterson
authors.affiliation: Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.
authors.forename: Alphonse
authors.initials: A
authors.lastname: Jeanneret
authors.affiliation: Montreal Chest Institute, Montreal, QC, Canada.
authors.forename: Elias
authors.initials: E
authors.lastname: Matouk
authors.affiliation: Le Centre Hospitalier Universitaire de Québec, Quebec City, QC, Canada.
authors.forename: Josee
authors.initials: J
authors.lastname: Villeneuve
authors.affiliation: Department of Medicine, McMaster University, Hamilton, ON, Canada.
authors.forename: Madeline
authors.initials: M
authors.lastname: Nixon
authors.affiliation: Department of Medicine, McMaster University, Hamilton, ON, Canada.
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Adachi
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019386:Alendronate / Q000008:administration & dosage*; D015519:Bone Density; D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D002170:Canada; D015331:Cohort Studies; D003550:Cystic Fibrosis / Q000150:complications*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008159:Lumbar Vertebrae / Q000293:injuries*; D008297:Male; D010024:Osteoporosis / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D016103:Spinal Fractures / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D050071:Bone Density Conservation Agents; D019386:Alendronate