Clinical Trials


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

This study has been completed
King's College London

St Thomas' Hospital, London

Information provided by (Responsible Party)
Barry Stephen Peters, King's College London Identifier

First received: August 13, 2012
Last updated: August 17, 2012
Last Verified: August 2012
History of Changes


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.

HIV Infection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Prospective Study to Determine the Optimum Age for Routine DEXA Screening for Osteopenia/Osteoporosis in People With HIV Infection

Further study details as provided by Barry Stephen Peters, King's College London:

Primary Outcome Measures

  • 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
Secondary Outcome Measures:
  • 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
  • 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
  • Vitamin D levels [ Time Frame: The outcome is measured within 6 months (0-6 months) after entry to the study. ]
    Plasma vitamin D

Biospecimen Retention: Samples Without DNA
Plasma and urine

Enrollment: 440
Study Start Date: February 2009
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

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


Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  
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.


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

contacts and locations

Contacts and Locations

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Please refer to this study by its identifier: NCT01669954


United Kingdom
St Thomas, Hospital
London, United Kingdom, SE30AA

Sponsors and Collaborators

King's College London
St Thomas' Hospital, London


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

More Information

Responsible Party: Barry Stephen Peters, Reader and Consultant HIV Medicine, Head of Research Unit, Principle Investigator, Clinical Researcher, King's College London Identifier: NCT01669954   History of Changes  
Other Study ID Numbers: RJ1 09/0329  
Study First Received: August 13, 2012  
Last Updated: August 17, 2012  

Keywords provided by Barry Stephen Peters, King's College London:

Bone mineral density
Vitamin D

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Osteoporosis processed this data on June 02, 2020
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