Alendronate once weekly for the prevention and treatment of bone loss in Canadian adult cystic fibrosis patients (CFOS trial).
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.
Papaioannou
Alexandra
A
Department of Medicine, McMaster University, Hamilton, ON, Canada. Electronic address: papaioannou@hhsc.ca.
Kennedy
Courtney C
CC
Department of Medicine, McMaster University, Hamilton, ON, Canada.
Freitag
Andreas
A
Department of Medicine, McMaster University, Hamilton, ON, Canada.
Ioannidis
George
G
Department of Medicine, McMaster University, Hamilton, ON, Canada.
O'Neill
John
J
Department of Medicine, McMaster University, Hamilton, ON, Canada.
Webber
Colin
C
Department of Nuclear Medicine, Hamilton Health Sciences, Hamilton, ON, Canada.
Pui
Margaret
M
Department of Diagnostic Imaging, Scarborough Hospital, Scarborough, ON, Canada.
Berthiaume
Yves
Y
Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.
Rabin
Harvey R
HR
Adult Cystic Fibrosis Clinic, University of Calgary Medical Clinic of the Foothills Medical Center, Calgary, AB, Canada.
Paterson
Nigel
N
Schulich School of Medicine and Dentistry, University of Western Ontario, London Health Science Centre, London, ON, Canada.
Jeanneret
Alphonse
A
Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.
Matouk
Elias
E
Montreal Chest Institute, Montreal, QC, Canada.
Villeneuve
Josee
J
Le Centre Hospitalier Universitaire de Québec, Quebec City, QC, Canada.
Nixon
Madeline
M
Department of Medicine, McMaster University, Hamilton, ON, Canada.
Adachi
Jonathan D
JD
Department of Medicine, McMaster University, Hamilton, ON, Canada.
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*
D050071:Bone Density Conservation Agents; D019386:Alendronate