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Alendronate Once Weekly for the Prevention and Treatment of Bone Loss in Canadian Adult Cystic Fibrosis Patients (CFOS Trial).

Author(s): Papaioannou A, Kennedy CC, Freitag A, Ioannidis G, O'Neill J, Webber C, Pui M, Berthiaume Y, Rabin HR, Paterson N, Jeanneret A, Matouk E, Villeneuve J, Nixon M, Adachi JD

Affiliation(s): Alexandra Papaioannou, MSc, FRCPC, McMaster University, Hamilton, ON, Canada; Courtney C. Kennedy, MSc, McMaster University, Hamilton, ON, Canada; Andreas Freitag, MD, FRCP, McMaster University, Hamilton, ON, Canada George Ioannidis, MSc, McMaster University, Hamilton, ON, Canada; John O'Neill, MB, BAO, BCh, FRCR, MSc, MRCPI, St. Joseph's Healthcare Hamilton, McMaster University, Hamilton Ontario, Canada; Colin Webber, Department of Nuclear Medicine, Hamilton Health Sciences, Hamilton, ON, Canada; Margaret Pui, MD, FRCPC, Department of Diagnostic Imaging, Scarborough Hospital, Scarborough, ON, Canada; Yves Berthiaume, MD, MSc, FRCP, Centre hospitalier de l'Universite de Montreal, Montreal, PQ, Canada; Harvey R. Rabin, MD, FRCPC, Adult Cystic Fibrosis Clinic, University of Calgary Medical Clinic of the Foothills Medical Center, Calgary, AB, Canada; Nigel Paterson, MB, BS, FRCPC, Schulich School of Medicine and Dentistry, University of Western Ontario, London Health Science Centre, London, ON, Canada; Alphonse Jeanneret, MD, FRCP, Centre hospitalier de l'Universite de Montreal, Montreal, PQ, Canada,; Elias Matouk, MB, ChB, FRCPC, Montreal Chest Institute, Montreal, PQ, Canada; Josee Villeneuve, MD, FRCPC, Le Centre hospitalier universitaire de Quebec, Quebec City, PQ, Canada; Madeline Nixon, BSc, McMaster University, Hamilton, ON, Canada; Jonathan D. Adachi, MD, FRCPC, McMaster University, Hamilton, ON, Canada.

Publication date & source: 2008-07-18, Chest., [Epub ahead of print]

Background Patients with cystic fibrosis (CF) are at risk for early bone loss and demonstrate increased risk for vertebral fractures and kyphosis. A multicentre, randomized controlled trial (RCT) was conducted to assess the efficacy, tolerability and safety of oral alendronate (FOSAMAX(R)) 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 Vitamin D and 1000 mg calcium daily. Adults with confirmed CF with a bone mineral density (BMD) T-score <-1.0 were eligible for inclusion. Participants with a prior organ transplantation and other reported contraindications were excluded. The primary outcome measure was mean percent change in lumbar spine BMD after 12 months (mean +/-Standard Deviation). Secondary measures included percent change in total hip BMD, 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). Absolute percent change in lumbar spine and total hip BMD at follow-up was significantly higher in the alendronate group (5.20 +/-3.67% and 2.14 +/-3.32%) versus the control group (-0.08 +/-3.93% and -1.3 +/-2.70%, p < .001). At follow-up, two participants (2 control, 0 alendronate) had a new vertebral fracture (not significant) and there were no differences in quality of life or number of adverse events (including serious and gastrointestinal-related). Conclusion Alendronate was well tolerated and produced a significantly greater increase in BMD over 12 months compared with placebo. ClinicalTrials.gov Identifier: NCT00157690.

Page last updated: 2008-08-11

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