Study of Bone Disease in Older HIV-infected Adults

NCT ID: NCT00935935

Last Updated: 2012-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-02-28

Brief Summary

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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

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Conditions

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Osteopenia Osteoporosis HIV Infection Aging HIV Infections

Keywords

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Treatment experienced

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HIV older than 50 years

No interventions assigned to this group

Eligibility Criteria

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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 \[\> 800 IU daily\]).
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Ruth M. Rothstein CORE Center

OTHER

Sponsor Role lead

Responsible Party

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oluwatoyin M. Adeyemi

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oluwatoyin Adeyemi, MD

Role: PRINCIPAL_INVESTIGATOR

Ruth M. Rothstein CORE Center

Locations

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Ruth M Rothstein CORE Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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Bone2009

Identifier Type: -

Identifier Source: org_study_id