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

Osteoporosis Clinical Trial

— UPBEAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01778361
• Other study ID #: HIVUPBEAT
• Status: Recruiting
• Start date: February 2011
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2019
• Source: University College Dublin
• Contact: Tara N mcGinty, MB BCh BAO
• Email: tara.mcginty[@]ucd.ie
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases
• Osteoporosis

Locations

Country	Name	City	State
Ireland	Mater Misericordiae University Hospital	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
University College Dublin	Health Research Board, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fracture incidence	To assess the validity of currently available fracture risk assessment tools in predicting fracture risk in HIV-infected patients.	3 years
Primary	Bone pathology	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	Rates of change in bone mineral density	To determine rates of change in bone mineral density in HIV-positive patients compared to HIV-negative controls	3 years