Alexandra Papaioannou1, Courtney C Kennedy2, Andreas Freitag2, George Ioannidis2, John O'Neill2, Colin Webber3, Margaret Pui4, Yves Berthiaume5, Harvey R Rabin6, Nigel Paterson7, Alphonse Jeanneret5, Elias Matouk8, Josee Villeneuve9, Madeline Nixon2, Jonathan D Adachi2. 1. Department of Medicine, McMaster University, Hamilton, ON, Canada. Electronic address: papaioannou@hhsc.ca. 2. Department of Medicine, McMaster University, Hamilton, ON, Canada. 3. Department of Nuclear Medicine, Hamilton Health Sciences, Hamilton, ON, Canada. 4. Department of Diagnostic Imaging, Scarborough Hospital, Scarborough, ON, Canada. 5. Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada. 6. Adult Cystic Fibrosis Clinic, University of Calgary Medical Clinic of the Foothills Medical Center, Calgary, AB, Canada. 7. Schulich School of Medicine and Dentistry, University of Western Ontario, London Health Science Centre, London, ON, Canada. 8. Montreal Chest Institute, Montreal, QC, Canada. 9. Le Centre Hospitalier Universitaire de Québec, Quebec City, QC, Canada.
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). CONCLUSION:Alendronate therapy was well tolerated and produced a significantly greater increase in BMD over 12 months compared with placebo.
RCT Entities:
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.
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