Study of Alendronate to Prevent and Treat Osteoporosis in Cystic Fibrosis Patients

Summary

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.

Timeline

Start

2003-12

Primary completion

2006-08

Completion

2006-08

Publications

• 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.
• Background 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.
• 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.

Drugs

Indications