Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004489
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis
Sponsor:
University of North Carolina
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
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:
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
II Assess the safety and efficacy of this treatment regimen in improving osteoporosis in this patient population
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UNCCH-FDR001518 | None | None | None |