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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amy H. Warriner, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01591252
First received: April 30, 2012
Last updated: December 3, 2013
Last verified: December 2013

April 30, 2012
December 3, 2013
April 2012
June 2014   (final data collection date for primary outcome measure)
Bone Mineral Density [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change in BMD after 1 year
Same as current
Complete list of historical versions of study NCT01591252 on ClinicalTrials.gov Archive Site
Fracture in HIV [ Time Frame: 10years ] [ Designated as safety issue: No ]
Fracture incidence in HIV+ vs. HIV- in Medicare sample
Same as current
Not Provided
Not Provided
 
Fracture and Bone Mineral Density in HIV+ Patients Recently Started on Antiretroviral Therapy (ART)
Fracture and Bone Mineral Density in HIV+ Patients Recently Started on Antiretroviral Therapy (ART)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

For primary outcomes: 1917 Clinic cohort. For secondary outcomes: Medicare sample.

  • HIV
  • Osteoporosis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
September 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01591252
HIVBone_K12
Yes
Amy H. Warriner, University of Alabama at Birmingham
University of Alabama at Birmingham
Not Provided
Principal Investigator: Amy H. Warriner, MD University of Alabama at Birmingham
University of Alabama at Birmingham
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP