Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157690
Status:
COMPLETED
Last Update Posted:
2008-10-23
First Post:
2005-09-08
Brief Title:
Study of Alendronate to Prevent and Treat Osteoporosis in Cystic Fibrosis Patients
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 spineLS bone mineral densityBMD in adult cystic fibrosisCFpatients 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
Detailed Description:
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 Dtablet
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None