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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Osteoporosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV positive

No interventions assigned to this group

HIV negative

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Patrick Mallon

Associate Dean of Post-graduate Research, School of Medicine and Medical Sciences, Head of HIV Molecular Research Group, Consultant Infectious Diseases.

Responsibility Role PRINCIPAL_INVESTIGATOR