Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis
OBJECTIVES: I. Determine the bioavailability and biologic effect of alendronate on bone metabolism in patients with cystic fibrosis.
II. Assess the safety and efficacy of this treatment regimen in improving osteoporosis in this patient population.
Drug: alendronate sodium
Drug: calcium carbonate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
|Study Start Date:||October 1998|
|Estimated Study Completion Date:||September 2002|
PROTOCOL OUTLINE: This is a randomized, double blind study. Patients will be stratified according to sex (male vs female) and osteoporosis disease severity (mild vs severe). Patients are randomized to one of two treatment arms.
Patients undergo bioavailability assessment to confirm the ability to absorb alendronate.
Arm I: Patients receive calcium and vitamin D supplements with a placebo daily for one month.
Arm II: Patients receive calcium and vitamin D supplements with oral alendronate daily for one month.
Treatment continues if differences are seen in bone mineral density between the treatment arms.
Patients are followed for biochemical response at week 6, 12, and 52. Bone mineral density is measured at 1 year and 2 years.
Completion date provided represents the completion date of the grant per OOPD records
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004489
|United States, North Carolina|
|University of North Carolina School of Medicine|
|Chapel Hill, North Carolina, United States, 27599-7070|
|Study Chair:||Robert Aris||University of North Carolina|