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

September 24, 2019 updated by: Patrick Mallon, University College Dublin

HIV UPBEAT: Understanding the Pathology of Bone Disease in HIV-infected. A Prospective Cohort Study of HIV-infected Patients and HIV-negative Subjects.

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 Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, D 7
        • Recruiting
        • Mater Misericordiae University Hospital
        • Sub-Investigator:
          • Gerard Sheehan, MB BCh BAO, FRCPI
        • Sub-Investigator:
          • John Lambert, MD, PhD
        • Contact:
        • Principal Investigator:
          • Patrick WG Mallon, MB BCh, PhD, FRCPI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV positive patients and HIV negative subjects

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HIV negative
HIV positive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone pathology
Time Frame: 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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of change in bone mineral density
Time Frame: 3 years
To determine rates of change in bone mineral density in HIV-positive patients compared to HIV-negative controls
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fracture incidence
Time Frame: 3 years
To assess the validity of currently available fracture risk assessment tools in predicting fracture risk in HIV-infected patients.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Dublin

Collaborators

Health Research Board, Ireland

Investigators

  • Principal Investigator: Patrick WG Mallon, MB BCh, BSc, PhD, HIV Molecular Research Group, University College Dublin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

January 25, 2013

First Submitted That Met QC Criteria

January 25, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIVUPBEAT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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