Determination of Optimum Age for DXA Screening for Osteoporosis in HIV - The Probono 1 Study (Probono1)

August 17, 2012 updated by: Barry Stephen Peters, King's College London

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

440

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A randomly recruited numbers of HIV uninfected controls and HIV patients aged 18 years or above, equally matched for age, and gender.

Description

Inclusion Criteria:

  • 18 years or above Not pregnant Able to comply with study observations and procedures Able to give fully informed consent

Exclusion Criteria:

  • Pregnant Less than 18 years of age Unable to comply with study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The outcome is measured within 6 months (0-6 months) after entry to the study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone mineral density at spine (L4)
Time Frame: The outcome is measured within 6 months (0-6 months) after entry to the study.
As determined by DXA scan
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.
Self-reported fractures of any type
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.
Plasma vitamin D
The outcome is measured within 6 months (0-6 months) after entry to the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

St Thomas' Hospital, London

Investigators

  • Principal Investigator: Barry S Peters, MD PhD, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

August 13, 2012

First Submitted That Met QC Criteria

August 17, 2012

First Posted (Estimate)

August 21, 2012

Study Record Updates

Last Update Posted (Estimate)

August 21, 2012

Last Update Submitted That Met QC Criteria

August 17, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJ1 09/0329
  • 08/H0805/56 (Other Identifier: National Research Ethics Service)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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