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

August 13, 2012
August 17, 2012
February 2009
May 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01669954 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Determination of Optimum Age for DXA Screening for Osteoporosis in HIV - The Probono 1 Study
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

Plasma and urine

Probability Sample

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

  • Osteoporosis
  • Fractures
  • HIV Infection
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
440
June 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01669954
RJ1 09/0329, 08/H0805/56
No
Barry Stephen Peters, King's College London
King's College London
St Thomas' Hospital, London
Principal Investigator: Barry S Peters, MD PhD King's College London
King's College London
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP