HIV UPBEAT: Understanding the Pathology of Bone Disease in HIV-infected Patients.

• Conditions: Osteoporosis

• Registration Number: NCT01778361
• Lead Sponsor: University College Dublin

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

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2013-01-25
• Study First Submitted QC: 2013-01-25
• Study First Posted: 2013-01-29
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• age >18 years
• be able to provide written, informed consent
• be able to attend the research centre in a fasting state and undergo DEXA scanning

Exclusion Criteria

• Subjects on bisphosphonate therapy at screening
• Pregnant or breastfeeding female subjects
• Subjects with a previous clinical history of primary hyperthyroidism or HIV negative subjects with elevated parathyroid hormone at screening
• HIV-negative subjects with a prior history of osteoporosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone pathology	3 years	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.

Secondary Outcome Measures

Name	Time	Method
Rates of change in bone mineral density	3 years	To determine rates of change in bone mineral density in HIV-positive patients compared to HIV-negative controls

Trial Locations

Locations (1)

Mater Misericordiae University Hospital; 🇮🇪 Dublin, Ireland