OsteoporosisUPBEATNCT01778361
HIV UPBEAT: Understanding the Pathology of Bone Disease in HIV-infected Patients.
An observational study of Osteoporosis, run by University College Dublin at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- How many people
- 500 participants
- Where
- 1 siteIreland
- Study dates
- Feb 2011to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV positive patients and HIV negative subjects
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Tara N mcGinty, MB BCh BAO contact
Babu Sumesh contact
Ireland1 site, 1 recruiting
- Recruiting
Mater Misericordiae University Hospital
Dublin, D 7
Tara n McGinty, MB BAO BCh, tara.mcginty@ucd.ie
Patrick WG Mallon, MB BCh, PhD, FRCPI
About this study
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.
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.
Read the 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
- Conditions
- Osteoporosis
- Keywords
- Human immunodeficiency virus, low bone mineral density, osteopenia, osteoporosis, fracture
- Medical subject headings
- Osteoporosis, Acquired Immunodeficiency Syndrome, Bone Diseases, Metabolic, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV positive | Not described | |
| HIV negative | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone pathology
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.
Measured: 3 years
Secondary outcomes (1)
Rates of change in bone mineral density
To determine rates of change in bone mineral density in HIV-positive patients compared to HIV-negative controls
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startFeb 2011
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland
- Responsible party
- Principal investigator, Patrick Mallon, University College Dublin
- Investigators
- Patrick WG Mallon, MB BCh, BSc, PhD, Principal investigator, HIV Molecular Research Group, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778361
- Sponsor's protocol ID
- HIVUPBEAT
- Acronym
- UPBEAT
- Status last verified
- Sep 2019
- First submitted
- 25 Jan 2013
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01778361
- Acronym / sponsor ID
- UPBEAT / HIVUPBEAT
- Conditions
- Osteoporosis
- Keywords
- Human immunodeficiency virus, low bone mineral density, osteopenia, osteoporosis, fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland
- Study start
- Feb 2011
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV positive | – | – |
| HIV negative | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV positive patients and HIV negative subjects
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Rates of change in bone mineral density
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tara N mcGinty, MB BCh BAO contact
Babu Sumesh contact
Patrick WG Mallon, MB BCh, BSc, PhD principal investigator
HIV Molecular Research Group, University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tara N mcGinty, MB BCh BAO (tara.mcginty@ucd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone pathology (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.