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

This study has been completed.
Information provided by (Responsible Party):
Amy H. Warriner, University of Alabama at Birmingham Identifier:
First received: April 30, 2012
Last updated: January 26, 2015
Last verified: January 2015

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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Fracture and Bone Mineral Density in HIV+ Patients Recently Started on Antiretroviral Therapy (ART)

Resource links provided by NLM:

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Change in BMD after 1 year

Secondary Outcome Measures:
  • Fracture in HIV [ Time Frame: 10years ] [ Designated as safety issue: No ]
    Fracture incidence in HIV+ vs. HIV- in Medicare sample

Estimated Enrollment: 200
Study Start Date: April 2012
Study Completion Date: September 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
For primary outcomes: 1917 Clinic cohort. For secondary outcomes: Medicare sample.

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
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Please refer to this study by its identifier: NCT01591252

United States, Alabama
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Principal Investigator: Amy H. Warriner, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Amy H. Warriner, Assistant Professor, University of Alabama at Birmingham Identifier: NCT01591252     History of Changes
Other Study ID Numbers: HIVBone_K12
Study First Received: April 30, 2012
Last Updated: January 26, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Bone mineral density
bone turnover
inflammation processed this record on November 30, 2015