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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT01591252

Collaborator

(none)

200

Enrollment

Location

Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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 , tumor necrosis factor alpha , high-sensitivity c-reactive protein ).

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Osteoporosis

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Outcome Measures

Primary Outcome Measures

Bone Mineral Density [1 year]
Change in BMD after 1 year

Secondary Outcome Measures

Fracture in HIV [10years]
Fracture incidence in HIV+ vs. HIV- in Medicare sample

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

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