OsteoporosisProbono1NCT01669954
Determination of Optimum Age for DXA Screening for Osteoporosis in HIV - The Probono 1 Study
An observational study of Osteoporosis and Fractures, run by King's College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the bone mineral density in male and female patients with HIV infection according to age groups. This will enable a practical approach to screening for osteoporosis and the management and prevention of fragility fractures in people with HIV. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Fractures, HIV Infection
- How many people
- 440 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2009to Jun 2012
- 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: A randomly recruited numbers of HIV uninfected controls and HIV patients aged 18 years or above, equally matched for age, and gender.
Who may be able to join
- 18 years or above Not pregnant Able to comply with study observations and procedures Able to give fully informed consent
Who cannot join
- Pregnant Less than 18 years of age Unable to comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study to Determine the Optimum Age for Routine DEXA Screening for Osteopenia/Osteoporosis in People With HIV Infection
The purpose of this study is to determine the bone mineral density in male and female patients with HIV infection according to age groups.
This will enable a practical approach to screening for osteoporosis and the management and prevention of fragility fractures in people with HIV.
In addition, all risk factors commonly associated with fragility fractures and osteoporosis are collected, as is HIV drug history.
Hence, as secondary outcomes, the associations with reduced bone mineral density can be ascertained.
- Conditions
- Osteoporosis, Fractures, HIV Infection
- Keywords
- HIV, Bone mineral density, Osteoporosis, Vitamin D, Fractures
- Medical subject headings
- Osteoporosis, Fractures, Bone, HIV Infections
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 |
|---|---|---|
| Controls, females | Controls who are presumed HIV uninfected, females, aged 18 or above | |
| Controls, males | Controls presumed HIV uninfected, males, aged 18 or above | |
| HIV infected patients, males | HIV patients, males, aged 18 or above | |
| HIV patients, | HIV patients, females, aged 18 or above |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density at Hip
Bone mineral density as determined by DXA scanning
Measured: The outcome is measured within 6 months (0-6 months) after entry to the study.
Secondary outcomes (3)
Bone mineral density at spine (L4)
As determined by DXA scan
Measured: The outcome is measured within 6 months (0-6 months) after entry to the study.
Any lifetime fractures reported by subjects
Self-reported fractures of any type
Measured: At any stage during persons life up to and including the last visit for the volunteer to the study.
Vitamin D levels
Plasma vitamin D
Measured: The outcome is measured within 6 months (0-6 months) after entry to the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startFeb 2009
- Primary completionMay 2012
- Study completionJun 2012
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.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- St Thomas' Hospital, London
- Responsible party
- Principal investigator, Barry Stephen Peters, King's College London
- Investigators
- Barry S Peters, MD PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669954
- Sponsor's protocol ID
- RJ1 09/0329
- Other IDs
- 08/H0805/56
- Acronym
- Probono1
- Status last verified
- Aug 2012
- First submitted
- 13 Aug 2012
- Last updated
- 21 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Determine the Optimum Age for Routine DEXA Screening for Osteopenia/Osteoporosis in People With HIV Infection
- ClinicalTrials.gov ID
- NCT01669954
- Acronym / sponsor ID
- Probono1 / RJ1 09/0329
- Conditions
- Osteoporosis, Fractures, HIV Infection
- Keywords
- HIV, Bone mineral density, Osteoporosis, Vitamin D, Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- St Thomas' Hospital, London
- Study start
- Feb 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 21 Aug 2012 (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.
The purpose of this study is to determine the bone mineral density in male and female patients with HIV infection according to age groups.
This will enable a practical approach to screening for osteoporosis and the management and prevention of fragility fractures in people with HIV.
In addition, all risk factors commonly associated with fragility fractures and osteoporosis are collected, as is HIV drug history.
Hence, as secondary outcomes, the associations with reduced bone mineral density can be ascertained.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Controls, females | – | –Controls who are presumed HIV uninfected, females, aged 18 or above |
| Controls, males | – | –Controls presumed HIV uninfected, males, aged 18 or above |
| HIV infected patients, males | – | –HIV patients, males, aged 18 or above |
| HIV patients, | – | –HIV patients, females, aged 18 or above |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A randomly recruited numbers of HIV uninfected controls and HIV patients aged 18 years or above, equally matched for age, and gender.
Key inclusion criteria (1 listed)
- 18 years or above Not pregnant Able to comply with study observations and procedures Able to give fully informed consent
Key exclusion criteria (1 listed)
- Pregnant Less than 18 years of age Unable to comply with study procedures
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 mineral density at Hip
Time frame: The outcome is measured within 6 months (0-6 months) after entry to the study.
Bone mineral density as determined by DXA scanning
3 secondary outcomes
Bone mineral density at spine (L4)
Time frame: The outcome is measured within 6 months (0-6 months) after entry to the study.
Any lifetime fractures reported by subjects
Time frame: At any stage during persons life up to and including the last visit for the volunteer to the study.
Vitamin D levels
Time frame: The outcome is measured within 6 months (0-6 months) after entry to the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
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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.
Barry S Peters, MD PhD principal investigator
King's College London
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 and Fractures, run by King's College London at 1 site in United Kingdom.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Aug 2012. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density at Hip (time frame: The outcome is measured within 6 months (0-6 months) after entry to the study.). 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 21 Aug 2012.