Fracture and Bone Mineral Density in HIV+ Patients Recently Started on Antiretroviral Therapy (ART)

Completed

• Conditions: Osteoporosis; HIV

• Registration Number: NCT01591252
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

In a group of HIV-positive patients under observation since their first exposure to ART or monitored off of ART, BMD changes over one year will be determined. For each subject, the investigators will also determine associations between changes in BMD and 1) ART initiation, 2) cumulative viremia (measured by copy-years viremia), and 3) inflammation (evaluated through the measurement of interleukin-6 {IL-6}, tumor necrosis factor alpha {TNF-a}, high-sensitivity c-reactive protein {hsCRP}).

Hypotheses: BMD will decrease less in persons initiated on ART than those monitored off of ART, after excluding those subjects treated with tenofovir.

BMD will decrease most significantly in HIV-positive subjects with the highest levels of cumulative viremia.

HIV-positive persons with highest cumulative viremia will have the highest levels of inflammation, as measured by pro-inflammatory cytokines.

Additionally, the investigators will evaluate fracture incidence in a 5% National Medicare sample and fracture association with the use of varying ART medications among dual-eligible persons in Medicare and Medicaid datasets.

Hypotheses: Fracture incidence will be greater in HIV-positive subjects compared to HIV-negative subjects.Fracture incidence will be greatest in subjects with the shortest duration of ART exposure.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-03
• Primary Completion: 2014-06
• Study Completion: 2014-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-31
• Last Update Posted: 2016-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• treatment naïve patients seen in the 1917 Clinic between January 1, 2000 and May 1, 2010
• currently under care at the time of the initiation of the study (>1 clinic visit in the past 12 months)

Read More

Exclusion Criteria

• history of chronic renal failure (estimated GFR <30ml/min)
• known diagnosis of a metabolic bone disease (i.e. osteoporosis, primary hyperparathyroidism, Paget Disease, Osteogenesis Imperfecta)
• multiple myeloma, cancer, untreated thyroid disease, or inflammatory bowel disease, or persons currently treated with or plans to begin an osteoporosis-specific medication (including estrogen)
• treatment with oral glucocorticoids and anticonvulsants

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density	1 year	Change in BMD after 1 year

Secondary Outcome Measures

Name	Time	Method
Fracture in HIV	10years	Fracture incidence in HIV+ vs. HIV- in Medicare sample

Trial Locations

Locations (1)

UAB; 🇺🇸 Birmingham, Alabama, United States