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

This study has been completed.
Sponsor:
Collaborator:
St Thomas' Hospital, London
Information provided by (Responsible Party):
Barry Stephen Peters, King's College London
ClinicalTrials.gov Identifier:
NCT01669954
First received: August 13, 2012
Last updated: August 17, 2012
Last verified: August 2012
History of Changes
  Purpose

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
Osteoporosis
Fractures
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:

U.S. FDA Resources

Further study details as provided by 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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)
Groups/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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669954

Locations
United Kingdom
St Thomas, Hospital
London, United Kingdom, SE30AA
Sponsors and Collaborators
King's College London
St Thomas' Hospital, London
Investigators
Principal Investigator: Barry S Peters, MD PhD Kings College London
  More Information

No publications provided

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
Study First Received: August 13, 2012
Last Updated: August 17, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by King's College London:
HIV
Bone mineral density
Osteoporosis
Vitamin D
Fractures

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Fractures, Bone
Osteoporosis
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
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 16, 2013