Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261950
Status:
COMPLETED
Last Update Posted:
2014-07-21
First Post:
2005-12-02
Brief Title:
Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
Bone Histomorphometry Assessment For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
Status:
COMPLETED
Status Verified Date:
2014-06
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:
BONAFIDE
Brief Summary:
The purpose of this study is to evaluate the effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis
Detailed Description:
Secondary hyperparathyroidism HPT is common in people with end stage renal disease kidney disease Patients with secondary HPT often have enlarged parathyroid glands in the neck and as a result often have elevated parathyroid hormone PTH levels Patients with secondary HPT may have bone disease osteodystrophy Cinacalcet has been used to decrease PTH levels in patients with secondary HPT Patients with secondary HPT may have bone disease osteodystrophy This bone disease may cause bone pain fractures and poor formation of red blood cells The purpose of this study is to evaluate effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BONAFIDE Study | OTHER | None | None |
| IND 56010 | OTHER | Food and Drug Administration | None |