Study of Bone Disease in Older HIV-infected Adults

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00935935

Enrollment

101

Registered

2009-07-09

Start date

2009-12-31

Completion date

2011-02-28

Last updated

2012-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, HIV Infection, HIV Infections, Osteopenia, Osteoporosis

Keywords

Treatment experienced

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

50 Years to 70 Years

Healthy volunteers

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 \[\> 800 IU daily\]).

Design outcomes

Primary

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

Countries

United States

Outcome results