HIV UPBEAT: Understanding the Pathology of Bone Disease in HIV-infected Patients.
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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.|
- Bone pathology [ Time Frame: 3 years ] [ Designated as safety issue: No ]To describe abnormalities in bone pathology in bone biopsies from HIV-infected subjects with low bone mineral density by comparing biopsy indices to reference ranges.
- Rates of change in bone mineral density [ Time Frame: 3 years ] [ Designated as safety issue: No ]To determine rates of change in bone mineral density in HIV-positive patients compared to HIV-negative controls
- Fracture incidence [ Time Frame: 3 years ] [ Designated as safety issue: No ]To assess the validity of currently available fracture risk assessment tools in predicting fracture risk in HIV-infected patients.
Biospecimen Retention: Samples With DNA
serum, plasma, buffy coat, urine
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
This study will follow HIV positive and negative subjects annually for 3 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778361
|Contact: Aoife G Cotter, MB BCh BAOfirstname.lastname@example.org|
|Contact: Sibongile Simelaneemail@example.com|
|Mater Misericordiae University Hospital||Recruiting|
|Dublin, Ireland, D 7|
|Contact: Aoife G Cotter, MB BAO BCh firstname.lastname@example.org|
|Principal Investigator: Patrick WG Mallon, MB BCh, PhD, FRCPI|
|Sub-Investigator: Gerard Sheehan, MB BCh BAO, FRCPI|
|Sub-Investigator: John Lambert, MD, PhD|
|Principal Investigator:||Patrick WG Mallon, MB BCh, BSc, PhD||HIV Molecular Research Group, University College Dublin|