Study of Bone Disease in Older HIV-infected Adults

This study has been completed.
Sponsor:
Collaborators:
Rush University Medical Center
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
oluwatoyin M. Adeyemi, Ruth M. Rothstein CORE Center
ClinicalTrials.gov Identifier:
NCT00935935
First received: July 8, 2009
Last updated: August 1, 2012
Last verified: August 2012

July 8, 2009
August 1, 2012
December 2009
February 2011   (final data collection date for primary outcome measure)
Assess the associations between outcome (bone density) and predictors (markers of inflammation and immune activation) using continuous variables [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00935935 on ClinicalTrials.gov Archive Site
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Study of Bone Disease in Older HIV-infected Adults
A Pilot Study on the Immunopathogenesis 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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Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Retention:   Samples Without DNA
Description:

Serum and plasma

Non-Probability Sample

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).

  • Osteopenia
  • Osteoporosis
  • HIV Infection
  • Aging
  • HIV Infections
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HIV older than 50 years
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
February 2011
February 2011   (final data collection date for primary outcome measure)

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]).
Both
50 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00935935
Bone2009
No
oluwatoyin M. Adeyemi, Ruth M. Rothstein CORE Center
Ruth M. Rothstein CORE Center
  • Rush University Medical Center
  • Merck Sharp & Dohme Corp.
Principal Investigator: Oluwatoyin Adeyemi, MD Ruth M. Rothstein CORE Center
Ruth M. Rothstein CORE Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP