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

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ClinicalTrials.gov Identifier: NCT01669954
Recruitment Status : Completed
First Posted : August 21, 2012
Last Update Posted : August 21, 2012
Information provided by (Responsible Party):

Study Description
Brief 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.

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.

Condition or disease
Osteoporosis Fractures HIV Infection

Study Design

Study Type : Observational
Actual Enrollment : 440 participants
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
Study Start Date : February 2009
Primary Completion Date : May 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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

Eligibility Criteria

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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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT01669954     History of Changes
Other Study ID Numbers: RJ1 09/0329
08/H0805/56 ( Other Identifier: National Research Ethics Service )
First Posted: August 21, 2012    Key Record Dates
Last Update Posted: August 21, 2012
Last Verified: August 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
Metabolic Diseases