Determination of Optimum Age for DXA Screening for Osteoporosis in HIV - The Probono 1 Study (Probono1)
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.
|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|
- 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
- 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
|Study Start Date:||February 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Controls who are presumed HIV uninfected, females, aged 18 or above
Controls presumed HIV uninfected, males, aged 18 or above
HIV infected patients, males
HIV patients, males, aged 18 or above
HIV patients, females, aged 18 or above
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669954
|St Thomas, Hospital|
|London, United Kingdom, SE30AA|
|Principal Investigator:||Barry S Peters, MD PhD||King's College London|