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
  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 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: oluwatoyin M. Adeyemi, principal investigator, Ruth M. Rothstein CORE Center
ClinicalTrials.gov Identifier: NCT00935935     History of Changes
Other Study ID Numbers: Bone2009
Study First Received: July 8, 2009
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Bone Diseases
Bone Diseases, Metabolic
Osteoporosis
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

ClinicalTrials.gov processed this record on August 20, 2014