HIV UPBEAT: Understanding the Pathology of Bone Disease in HIV-infected Patients.
This study is currently recruiting participants.
Verified January 2013 by University College Dublin
Sponsor:
University College Dublin
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
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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 University College Dublin:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
Other Outcome Measures:
- 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.
Biospecimen Retention: Samples With DNA
serum, plasma, buffy coat, urine
Estimated Enrollment: | 500 |
Study Start Date: | February 2011 |
Estimated Study Completion Date: | October 2013 |
Estimated Primary Completion Date: | October 2013 (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 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
![](https://webarchive.library.unt.edu/web/20130312000734im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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
![](https://webarchive.library.unt.edu/web/20130312000734im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778361
Contacts
Contact: Aoife G Cotter, MB BCh BAO | aoife.cotter@ucdconnect.ie | |
Contact: Sibongile Simelane | sibongile.simelane@ucd.ie |
Locations
Ireland | |
Mater Misericordiae University Hospital | Recruiting |
Dublin, Ireland, D 7 | |
Contact: Aoife G Cotter, MB BAO BCh aoife.cotter@ucdconnect.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 |
![](https://webarchive.library.unt.edu/web/20130312000734im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
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 |
Study First Received: | January 25, 2013 |
Last Updated: | January 25, 2013 |
Health Authority: | Ireland: Research Ethics Committee, Mater Misericordiae University Hospital, Dublin |
Keywords provided by University College Dublin:
Human immunodeficiency virus low bone mineral density osteopenia osteoporosis fracture |
Additional relevant MeSH terms:
Bone Diseases Osteoporosis Musculoskeletal Diseases Bone Diseases, Metabolic |
ClinicalTrials.gov processed this record on March 10, 2013