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Original Research: CYSTIC FIBROSIS |

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

Alexandra Papaioannou, MD, MSc; Courtney C. Kennedy, MSc; Andreas Freitag, MD, FCCP; George Ioannidis, MSc; John O'Neill, MB, BAO, BCh, MSc; Colin Webber, PhD; Margaret Pui, MD; Yves Berthiaume, MD, MSc; Harvey R. Rabin, MD; Nigel Paterson, MB, BS, FCCP; Alphonse Jeanneret, MD; Elias Matouk, MB, ChB; Josee Villeneuve, MD; Madeline Nixon, BSc; Jonathan D. Adachi, MD
Author and Funding Information

*From the Department of Medicine (Drs. Papaioannou, Freitag, O'Neill and Adachi, Ms. Kennedy, Mr. Ioannidis, and Ms. Nixon), McMaster University, Hamilton, ON, Canada; the Department of Nuclear Medicine (Dr. Webber), Hamilton Health Sciences, Hamilton, ON, Canada; the Department of Diagnostic Imaging (Dr. Pui), Scarborough Hospital, Scarborough, ON, Canada; Centre Hospitalier de l'Université de Montréal (Drs. Berthiaume and Jeanneret), Montreal, QC, Canada; the Adult Cystic Fibrosis Clinic (Dr. Rabin), University of Calgary Medical Clinic of the Foothills Medical Center, Calgary, AB, Canada; the Schulich School of Medicine and Dentistry (Dr. Patterson), University of Western Ontario, London Health Science Centre, London, ON, Canada; the Montreal Chest Institute (Dr. Matouk), Montreal, QC, Canada; and Le Centre Hospitalier Universitaire de Québec (Dr. Villeneuve), Quebec City, QC, Canada.

Correspondence to: Alexandra Papaioannou, MD, MSc, Division of Geriatric Medicine, McMaster University, Hamilton Health Sciences, Chedoke Site, Building 74, 1200 Main St West, Hamilton, ON, Canada L8N 3Z5; e-mail: papaioannou@hhsc.ca


Patients were recruited for the study from speciality clinics at McMaster University, Hamilton, ON, Canada; Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada; University of Calgary, Calgary, AB, Canada; London Health Science Centre, London, ON, Canada; Montreal Chest Institute, Montréal, QC, Canada; and Le Centre Hospitalier Universitaire de Québec, Québec City, QC, Canada. Centralized analyses of bone marker samples, radiograph readings, bone mineral density readings and statistical analyses were performed at the following: McMaster University; and Laval University Medical Center (CHUL), Québec City, QC, Canada.

Study funding was provided by Merck Frosst Canada.

Dr. Papaioannou has had consulting and advisory roles for Amgen, Eli Lilly, Merck Frosst, Novartis, Proctor & Gamble, sanofi-aventis, and Servier; she has participated in clinical trials sponsored by Amgen, Eli Lilly, Merck, Novartis, Proctor & Gamble, and sanofi-aventis. Dr. Adachi has had consulting roles for Amgen, Astra Zeneca, Eli Lilly, GlaxoSmithKline, Merck Frosst, Novartis, Proctor & Gamble, Roche, sanofi-aventis, and Servier; he has participated in clinical trials sponsored by Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer, Proctor & Gamble, sanofi-aventis, Servier, and Wyeth-Ayerst. Ms. Kennedy, Dr. Freitag, Mr. Ioannidis, Dr. O'Neill, Dr. Webber, Dr. Pui, Dr. Berthiaume, Dr. Rabin, Dr. Paterson, Dr. Jeanneret, Dr. Matouk, Dr. Villeneuve, and Ms. Nixon have reported to the ACCP that no significant conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).


Chest. 2008;134(4):794-800. doi:10.1378/chest.08-0608
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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).

Conclusion:  Alendronate therapy was well tolerated and produced a significantly greater increase in BMD over 12 months compared with placebo.

Trial registration:  ClinicalTrials.gov Identifier: NCT00157690

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