Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
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

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

Resource links provided by NLM:

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
08/H0805/56 ( Other Identifier: National Research Ethics Service )
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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases processed this record on May 25, 2017