Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2026-02-06 @ 2:03 AM
Study NCT ID:
NCT01778361
Status:
UNKNOWN
Last Update Posted:
2019-09-25
First Post:
2013-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HIV UPBEAT: Understanding the Pathology of Bone Disease in HIV-infected Patients.
Sponsor:
University College Dublin
Organization:
Study Overview
Official Title:
HIV UPBEAT: Understanding the Pathology of Bone Disease in HIV-infected. A Prospective Cohort Study of HIV-infected Patients and HIV-negative Subjects.
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
RECRUITING
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:
UPBEAT
Brief Summary:
Despite the prevalence of osteopenia and osteoporosis in the HIV positive population, relatively little is known about the underlying pathology. This prospective cohort study aims to gain further understanding about a number of issues relating to low bone mineral density in HIV-infected subjects.
Detailed Description:
This study will follow HIV positive and negative subjects annually for 5 years. The aims of this study include:
* to describe the pathology underlying low bone mineral density
* to assess the relationship between low bone mineral density and antiretroviral therapy exposure
* to assess the relationship between low bone mineral density and vitamin D /PTH status and/or markers of bone metabolism
* to assess the relationship between osteopenia and subsequent changes in bone mineral density and markers of bone metabolism
* to assess the validity of the currently available fracture risk assessment tool in predicting fractures in HIV positive populations
* to describe the pathology underlying low bone mineral density
* to assess the relationship between low bone mineral density and antiretroviral therapy exposure
* to assess the relationship between low bone mineral density and vitamin D /PTH status and/or markers of bone metabolism
* to assess the relationship between osteopenia and subsequent changes in bone mineral density and markers of bone metabolism
* to assess the validity of the currently available fracture risk assessment tool in predicting fractures in HIV positive populations
Study Oversight
Has Oversight DMC:
False
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?: