Study of Bone Disease in Older HIV-infected Adults

HIV Infections Clinical Trial

Official title:

A Pilot Study on the Immunopathogenesis of Bone Disease in Older HIV-infected Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935935
• Other study ID #: Bone2009
• Status: Completed
• Phase: N/A
• First received: July 8, 2009
• Last updated: August 1, 2012
• Start date: December 2009
• Est. completion date: February 2011

Study information

• Verified date: August 2012
• Source: Ruth M. Rothstein CORE Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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]).

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Aging
• Bone Diseases
• HIV Infection
• HIV Infections
• Infection
• Osteopenia
• Osteoporosis

Locations

Country	Name	City	State
United States	Ruth M Rothstein CORE Center	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Ruth M. Rothstein CORE Center	Merck Sharp & Dohme Corp., Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the associations between outcome (bone density) and predictors (markers of inflammation and immune activation) using continuous variables		6 months	No