Study of Bone Disease in Older HIV-infected Adults

NCT00935935 | Completed

• 1 other identifier: Bone2009
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteopenia; Osteoporosis; HIV Infection; Aging; HIV Infections

Keywords

Treatment experienced

Outcome Measures

Primary Outcomes (1)

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

  6 months

Study Arms (1)

HIV older than 50 years

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• Known bone disease (primary or metastatic malignancy, osteomalacia)
• Treatment for bone disease (bisphosphonates, calcitonin, strontium, sodium fluoride, synthetic PTH, or high-dose vitamin D \[\> 800 IU daily\]).

Sponsors & Collaborators

• Ruth M. Rothstein CORE Center: lead
• Rush University Medical Center: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Ruth M Rothstein CORE Center

Chicago, Illinois, 60612, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis; HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Oluwatoyin Adeyemi, MD

  Ruth M. Rothstein CORE Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 9, 2009
• Study Start: December 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: August 3, 2012

Record last verified: 2012-08

Locations

US (1)