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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by University College Dublin
Health Research Board, Ireland
Information provided by (Responsible Party):
Patrick Mallon, University College Dublin Identifier:
First received: January 25, 2013
Last updated: November 29, 2016
Last verified: November 2016
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 Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:

Further study details as provided by University College Dublin:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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

Other Outcome Measures:
  • 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.

Biospecimen Retention:   Samples With DNA
serum, plasma, buffy coat, urine

Estimated Enrollment: 500
Study Start Date: February 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
HIV positive
HIV negative

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
HIV positive patients and HIV negative subjects

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01778361

Contact: Tara N mcGinty, MB BCh BAO
Contact: Babu Sumesh

Mater Misericordiae University Hospital Recruiting
Dublin, Ireland, D 7
Contact: Tara n McGinty, MB BAO BCh   
Principal Investigator: Patrick WG Mallon, MB BCh, PhD, FRCPI         
Sub-Investigator: Gerard Sheehan, MB BCh BAO, FRCPI         
Sub-Investigator: John Lambert, MD, PhD         
Sponsors and Collaborators
University College Dublin
Health Research Board, Ireland
Principal Investigator: Patrick WG Mallon, MB BCh, BSc, PhD HIV Molecular Research Group, University College Dublin
  More Information

Responsible Party: Patrick Mallon, Associate Dean of Post-graduate Research, School of Medicine and Medical Sciences, Head of HIV Molecular Research Group, Consultant Infectious Diseases., University College Dublin Identifier: NCT01778361     History of Changes
Other Study ID Numbers: HIVUPBEAT
Study First Received: January 25, 2013
Last Updated: November 29, 2016

Keywords provided by University College Dublin:
Human immunodeficiency virus
low bone mineral density

Additional relevant MeSH terms:
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases processed this record on May 23, 2017