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Sponsors and Collaborators: |
McMaster University Centre hospitalier de l'Université de Montréal (CHUM) London Health Sciences Centre University of Calgary McGill University Laval University Merck Frosst Canada Ltd. |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00157690 |
The primary objective of this study is to determine efficacy of 70 mg alendronate once weekly compared to placebo. This will be measured by percent changes in lumbar spine(LS) bone mineral density(BMD) in adult cystic fibrosis(CF)patients after one year of treatment. The investigators hypothesize that in adult CF patients with osteopenia or osteoporosis, alendronate 70 mg once weekly will produce a mean increase from baseline in lumbar spine BMD that is greater than that observed with placebo at 12 months.
Condition | Intervention | Phase |
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Cystic Fibrosis Osteoporosis Bone Diseases, Metabolic |
Drug: Alendronate Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicentre, Double-Blind, Randomized Placebo-Controlled Study of 70mg Alendronate Once Weekly for the Prevention and Treatment of Osteoporosis in Canadian Adult Cystic Fibrosis Patients |
Enrollment: | 56 |
Study Start Date: | December 2003 |
Study Completion Date: | August 2006 |
Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Alendronate
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Drug: Alendronate
70 mg 1x weekly for 12 months
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2: Placebo Comparator
Placebo
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Drug: Placebo
70 mg 1 x weekly for 12 months
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Randomized controled trial have begun to establish the efficacy and safety of bisphosphonates in CF patients with decreased BMD. The development of a once weekly dosing regimen of alendronate and the low prevalence of esophageal adverse events may be an advantageous therapeutic option for this high-risk population. This is a one-year randomized, double-blind, placebo-controlled, multicentre study in 55 CF patients with osteopenia or osteoporosis. Six Canadian centres are participating in this study. Patients randomized to treatment will receive 70 mg oral alendronate once weekly, while controls will receive identical placebo once weekly. All medication dispensed will be concealed. There will be no dose modification during the course of the trial. All patients will receive a total of 1000 mg calcium, 500 through supplementation and 500 through diet. All patients will continue to take vitamin D supplementation ( 2 tablets per day, 400 IU vitamin D/tablet).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Alberta | |
Dr. Harvey Rabin - Health Sciences Centre | |
Calgary, Alberta, Canada, T2N 4N1 | |
Canada, Ontario | |
McMaster University | |
Hamilton, Ontario, Canada | |
London Health Sciences Centre | |
London, Ontario, Canada, N6A 4G5 | |
Canada, Quebec | |
CHUL Hospital | |
Sainte-Foy, Quebec, Canada, G1V 4G2 | |
Montreal Chest Institute | |
Montreal, Quebec, Canada, H2X 2P4 | |
Centre de Recherche - CHUM | |
Montreal, Quebec, Canada, H2W 1T7 |
Principal Investigator: | Alexandra Papaioannou, M.D. | McMaster University |
Study Chair: | Andreas Freitag, M.D. | McMaster University |
Study Chair: | Jonathan D Adachi, M.D. | McMaster University |
Responsible Party: | McMaster University ( Dr. Alexandra Papaioannou ) |
Study ID Numbers: | MK-0217 Protocol 214 |
Study First Received: | September 8, 2005 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00157690 |
Health Authority: | Canada: Health Canada |
Alendronate Bisphosphonates Cystic Fibrosis Osteoporosis |
Metabolic Diseases Fibrosis Osteoporosis Bone Diseases, Metabolic Bone Diseases Diphosphonates Digestive System Diseases Cystic Fibrosis Musculoskeletal Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Alendronate Lung Diseases Pancreatic Diseases Infant, Newborn, Diseases Metabolic disorder Cystic fibrosis |
Pathologic Processes Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |