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

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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01778361

Acronym

UPBEAT

Enrollment

500

Registered

2013-01-29

Start date

2011-02-28

Completion date

2020-12-31

Last updated

2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

Human immunodeficiency virus, low bone mineral density, osteopenia, osteoporosis, fracture

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Other

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

Countries

Ireland

Contacts

Primary ContactTara N mcGinty, MB BCh BAO

tara.mcginty@ucd.ie

Backup ContactBabu Sumesh

sumesh.babu@ucd.ie

Outcome results