A Pilot Study on the Immunopathogenesis of Bone Disease in Older HIV-infected Adults

Ruth M. Rothstein CORE Center1 site in 1 country101 target enrollmentDecember 2009

ConditionsOsteopenia Osteoporosis HIV Infection Aging HIV Infections

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteopenia
Sponsor: Ruth M. Rothstein CORE Center
Enrollment: 101
Locations: 1
Primary Endpoint: Assess the associations between outcome (bone density) and predictors (markers of inflammation and immune activation) using continuous variables
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will look to see if there are changes in the blood cells that are associated with bone disease and sort out effects that are due to the HIV virus itself, the medications and see if faster aging occurs in the cells of HIV infected persons. Bone disease will be measured by a special X-ray called a DEXA scan. A DEXA scan is used by doctors to see if someone has normal bone mass for their age or if there is thinning of the bones.

The purposes of this study are:

to learn how common bone disease is in HIV infected patients over the age of 50 years that receive their care at the CORE Center
to see what are the common causes of bone disease in older HIV infected persons
to see if there are differences in blood cells and levels of cytokines in patients who do or do not have bone disease, as this may help researchers determine the cause of bone disease.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

February 2011

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Ruth M. Rothstein CORE Center

Responsible Party

Principal Investigator

oluwatoyin M. Adeyemi

principal investigator

Ruth M. Rothstein CORE Center

Eligibility Criteria

Inclusion Criteria

•HIV-1 infection documented by ELISA and confirmed by western blot
•Treatment with antiretroviral drugs for at least 12 months
•Age 50-70 years
•CD4 count \> 350 cells/mm3 for at least 6 months
•HIV-RNA undetectable (\< 75 copies/ml for at least 6 months)

Exclusion Criteria

•Known bone disease (primary or metastatic malignancy, osteomalacia)
•Treatment for bone disease (bisphosphonates, calcitonin, strontium, sodium fluoride, synthetic PTH, or high-dose vitamin D \[\> 800 IU daily\]).