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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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 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
Eligibility| 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
Contacts and Locations
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 |
More Information
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
