Study of Bone Disease in Older HIV-infected Adults

Completed

• Conditions: HIV Infections; HIV Infection; Osteopenia; Osteoporosis; Aging

• Registration Number: NCT00935935
• Lead Sponsor: Ruth M. Rothstein CORE Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-08
• Study First Submitted QC: 2009-07-08
• Study First Posted: 2009-07-09
• Study Start: 2009-12
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-01
• Last Update Posted: 2012-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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]).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the associations between outcome (bone density) and predictors (markers of inflammation and immune activation) using continuous variables	6 months

Trial Locations

Locations (1)

Ruth M Rothstein CORE Center; 🇺🇸 Chicago, Illinois, United States