Study of Bone Disease in Older HIV-infected Adults

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.

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Key information

Conditions

Osteopenia Aging Blood-Borne Infections Bone Diseases Bone Diseases, Metabolic Communicable Diseases Genital Diseases HIV Infection HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruth M Rothstein CORE Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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]).

Treatment and study plan

Primary outcomes

Assess the associations between outcome (bone density) and predictors (markers of inflammation and immune activation) using continuous variables

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Ruth M. Rothstein CORE Center

Other

Collaborators

Merck Sharp & Dohme LLC
Rush University Medical Center

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Jul 9, 2009
Registry last updated: Aug 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed