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

University College Dublin

Status: Unknown

Conditions: Osteoporosis

Study type: Observational

Funder types: Other

Identifiers

NCT01778361

HIVUPBEAT

Details and patient eligibility

About

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.

Full 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

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

500 participants in 2 patient groups

HIV positive

HIV negative