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| Name | Class |
|---|---|
| Centre hospitalier de l'Université de Montréal (CHUM) | OTHER |
| London Health Sciences Centre | OTHER |
| University of Calgary | OTHER |
| McGill University |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Alendronate |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alendronate | Drug | 70 mg 1x weekly for 12 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine efficacy of 70 mg alendronate once weekly compared to placebo, measured by changes in LS BMD in adult CF patients after one year of treatment | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the efficacy of 70 mg alendronate once weekly compared to placebo measured by percent changes in total hip BMD, proximal femur BMD, and N-telopeptide at one year in adult CF patients. | 12 months | |
| To determine health-related quality of life (HRQL) using the SF-36 instrument. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Papaioannou, M.D. | McMaster University | Principal Investigator |
| Andreas Freitag, M.D. | McMaster University | Study Chair |
| Jonathan D Adachi, M.D. | McMaster University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Harvey Rabin - Health Sciences Centre | Calgary | Alberta | T2N 4N1 | Canada | ||
| McMaster University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14563654 | Background | Aris RM, Lester GE, Caminiti M, Blackwood AD, Hensler M, Lark RK, Hecker TM, Renner JB, Guillen U, Brown SA, Neuringer IP, Chalermskulrat W, Ontjes DA. Efficacy of alendronate in adults with cystic fibrosis with low bone density. Am J Respir Crit Care Med. 2004 Jan 1;169(1):77-82. doi: 10.1164/rccm.200307-1049OC. Epub 2003 Oct 16. | |
| 15613415 |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| OTHER |
| Laval University | OTHER |
| Merck Frosst Canada Ltd. | INDUSTRY |
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| Placebo | Drug | 70 mg 1 x weekly for 12 months |
|
| 12 months |
| To determine HRQL using the Cystic Fibrosis Questionnaire (CFQ). | 12 months |
| To determine the safety of 70 mg of alendronate given once weekly compared with placebo in adult CF patients | 12 months |
| To determine correlations between BMD and patient characteristics, including but not limited to the following: corticosteroid use, height, weight, body mass index BMI) and forced expired volume in 1 minute (FEV1). | 12 months |
| Hamilton |
| Ontario |
| Canada |
| London Health Sciences Centre | London | Ontario | N6A 4G5 | Canada |
| Centre de Recherche - CHUM | Montreal | Quebec | H2W 1T7 | Canada |
| Montreal Chest Institute | Montreal | Quebec | H2X 2P4 | Canada |
| CHUL Hospital | Sainte-Foy | Quebec | G1V 4G2 | Canada |
| Aris RM, Merkel PA, Bachrach LK, Borowitz DS, Boyle MP, Elkin SL, Guise TA, Hardin DS, Haworth CS, Holick MF, Joseph PM, O'Brien K, Tullis E, Watts NB, White TB. Guide to bone health and disease in cystic fibrosis. J Clin Endocrinol Metab. 2005 Mar;90(3):1888-96. doi: 10.1210/jc.2004-1629. Epub 2004 Dec 21. |
| 18641106 | Derived | 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. Alendronate once weekly for the prevention and treatment of bone loss in Canadian adult cystic fibrosis patients (CFOS trial). Chest. 2008 Oct;134(4):794-800. doi: 10.1378/chest.08-0608. Epub 2008 Jul 18. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |