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

This study is currently recruiting participants.
Verified November 2016 by Patrick Mallon, University College Dublin
Sponsor:
ClinicalTrials.gov Identifier:
NCT01778361
First Posted: January 29, 2013
Last Update Posted: November 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Health Research Board, Ireland
Information provided by (Responsible Party):
Patrick Mallon, University College Dublin
  Purpose
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.

Condition
Osteoporosis

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 Patrick Mallon, 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)
Groups/Cohorts
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
  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778361


Contacts
Contact: Tara N mcGinty, MB BCh BAO tara.mcginty@ucd.ie
Contact: Babu Sumesh sumesh.babu@ucd.ie

Locations
Ireland
Mater Misericordiae University Hospital Recruiting
Dublin, Ireland, D 7
Contact: Tara n McGinty, MB BAO BCh       tara.mcginty@ucd.ie   
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
Investigators
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
ClinicalTrials.gov Identifier: NCT01778361     History of Changes
Other Study ID Numbers: HIVUPBEAT
First Submitted: January 25, 2013
First Posted: January 29, 2013
Last Update Posted: November 30, 2016
Last Verified: November 2016

Keywords provided by Patrick Mallon, University College Dublin:
Human immunodeficiency virus
low bone mineral density
osteopenia
osteoporosis
fracture

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Metabolic Diseases