Ignite Creation Date:
2024-05-06 @ 8:54 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02853539
Status:
COMPLETED
Last Update Posted:
2016-08-03
First Post:
2016-07-19
Brief Title:
Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients
Sponsor:
Stanley Dudricks Memorial Hospital
Organization:
Stanley Dudricks Memorial Hospital
Study Overview
Official Title:
Denosumab Counteracts Metabolic Bone Disease in Chronic Intestinal Failure Patients A Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2016-07
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:
Denoz
Brief Summary:
Low bone mineral density BMD is commonly reported in patients receiving home parenteral nutrition HPN Denosumab represent a new drug which helped to prevent osteoclast The aim of the study was to assess its value in chronic intestinal failure patients
Detailed Description:
Low bone mineral density BMD is commonly reported in patients receiving home parenteral nutrition HPN Oral and intravenous calcium vitamin D and bisphosphonates have been commonly used to treat BMD but their efficiency is may be inadequate due to limited absorption and compliance Denosumab represent a new drug which helped to prevent osteoclast development and activation hence decreased bone resorption in some studies The aim of the study was to assess its value in chronic intestinal failure patients receiving HPN
Between November 2011 and March 2013 denosumab was administered to 16 HPN patients 9 F 7 M mean age 554 with intestinal failure Regional dual-energy x-ray absorptiometry of spine and hip were performed before the therapy was initiated and after 12 months BMD T-score and Z-score were measured
Between November 2011 and March 2013 denosumab was administered to 16 HPN patients 9 F 7 M mean age 554 with intestinal failure Regional dual-energy x-ray absorptiometry of spine and hip were performed before the therapy was initiated and after 12 months BMD T-score and Z-score were measured
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