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Study of Bone Disease in Older HIV-infected Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00935935
First Posted: July 9, 2009
Last Update Posted: August 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Rush University Medical Center
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
oluwatoyin M. Adeyemi, Ruth M. Rothstein CORE Center
  Purpose

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.

Condition
Osteopenia Osteoporosis HIV Infection Aging HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Pilot Study on the Immunopathogenesis of Bone Disease in Older HIV-infected Adults

Resource links provided by NLM:


Further study details as provided by oluwatoyin M. Adeyemi, Ruth M. Rothstein CORE Center:

Primary Outcome Measures:
  • Assess the associations between outcome (bone density) and predictors (markers of inflammation and immune activation) using continuous variables [ Time Frame: 6 months ]

Biospecimen Retention:   Samples Without DNA
Serum and plasma

Enrollment: 101
Study Start Date: December 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV older than 50 years

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

100 HIV-infected adults, age 50 years or older, on HAART with undetectable viral loads, who are randomly sampled from 6 strata defined by ethnicity (Black:White:Hispanic; 2:1:1) and sex (male:female; 1:1).

100 HIV+ adults, age ≥ 50 yr (50 ♂, 50 ♀; 50 AA, 25 W, 25 H).

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]).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935935


Locations
United States, Illinois
Ruth M Rothstein CORE Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Ruth M. Rothstein CORE Center
Rush University Medical Center
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Oluwatoyin Adeyemi, MD Ruth M. Rothstein CORE Center
  More Information

Responsible Party: oluwatoyin M. Adeyemi, principal investigator, Ruth M. Rothstein CORE Center
ClinicalTrials.gov Identifier: NCT00935935     History of Changes
Other Study ID Numbers: Bone2009
First Submitted: July 8, 2009
First Posted: July 9, 2009
Last Update Posted: August 3, 2012
Last Verified: August 2012

Keywords provided by oluwatoyin M. Adeyemi, Ruth M. Rothstein CORE Center:
Treatment experienced

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Musculoskeletal Diseases