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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University College Dublin
Sponsor:
Collaborator:
Health Research Board, Ireland
Information provided by (Responsible Party):
Patrick Mallon, University College Dublin
ClinicalTrials.gov Identifier:
NCT01778361
First received: January 25, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted

January 25, 2013
January 25, 2013
February 2011
October 2013   (final data collection date for primary outcome measure)
Bone pathology [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
Rates of change in bone mineral density [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To determine rates of change in bone mineral density in HIV-positive patients compared to HIV-negative controls
Same as current
Fracture incidence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To assess the validity of currently available fracture risk assessment tools in predicting fracture risk in HIV-infected patients.
Same as current
 
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.

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.

This study will follow HIV positive and negative subjects annually for 3 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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

serum, plasma, buffy coat, urine

Non-Probability Sample

HIV positive patients and HIV negative subjects

Osteoporosis
Not Provided
  • HIV positive
  • HIV negative
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Aoife G Cotter, MB BCh BAO aoife.cotter@ucdconnect.ie
Contact: Sibongile Simelane sibongile.simelane@ucd.ie
Ireland
 
NCT01778361
HIVUPBEAT
No
Patrick Mallon, University College Dublin
University College Dublin
Health Research Board, Ireland
Principal Investigator: Patrick WG Mallon, MB BCh, BSc, PhD HIV Molecular Research Group, University College Dublin
University College Dublin
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP