Determination of Optimum Age for DXA Screening for Osteoporosis in HIV - The Probono 1 Study (Probono1)
|ClinicalTrials.gov Identifier: NCT01669954|
Recruitment Status : Completed
First Posted : August 21, 2012
Last Update Posted : August 21, 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.
|Condition or disease|
|Osteoporosis Fractures HIV Infection|
|Study Type :||Observational|
|Actual Enrollment :||440 participants|
|Observational Model:||Case Control|
|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|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||June 2012|
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
- 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
- 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
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
|St Thomas, Hospital|
|London, United Kingdom, SE30AA|
|Principal Investigator:||Barry S Peters, MD PhD||King's College London|