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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01591252
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : June 2, 2016
Information provided by (Responsible Party):
Amy H. Warriner, 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.

Condition or disease
HIV Osteoporosis

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Study Type : Observational
Estimated 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 : April 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Bone Mineral Density [ Time Frame: 1 year ]
    Change in BMD after 1 year

Secondary Outcome Measures :
  1. Fracture in HIV [ Time Frame: 10years ]
    Fracture incidence in HIV+ vs. HIV- in Medicare sample

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01591252

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

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Responsible Party: Amy H. Warriner, Assistant Professor, University of Alabama at Birmingham Identifier: NCT01591252    
Other Study ID Numbers: HIVBone_K12
First Posted: May 3, 2012    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: May 2016
Keywords provided by Amy H. Warriner, University of Alabama at Birmingham:
Bone mineral density
bone turnover
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents