Fracture and Bone Mineral Density in HIV+ Patients Recently Started on Antiretroviral Therapy (ART)
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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 |
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HIV Bone Mineral Density Bone Turnover Fracture |
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) |
- Bone Mineral Density [ Time Frame: 1 year ] [ Designated as safety issue: No ]Change in BMD after 1 year
- 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 |
Estimated Study Completion Date: | September 2013 |
Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
![](https://webarchive.library.unt.edu/web/20130312000722im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
![](https://webarchive.library.unt.edu/web/20130312000722im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Contact: Amy Warriner, MD | 2059344112 | warriner@uab.edu |
Contact: Kentress Davison | 2059759308 | kdavison@uab.edu |
United States, Alabama | |
UAB | Recruiting |
Birmingham, Alabama, United States, 35233 | |
Contact: Amy Warriner, MD 205-934-4112 warriner@uab.edu | |
Principal Investigator: Amy H. Warriner, MD |
Principal Investigator: | Amy H. Warriner, MD | University of Alabama at Birmingham |
![](https://webarchive.library.unt.edu/web/20130312000722im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Amy H. Warriner, Assistant Professor, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT01591252 History of Changes |
Other Study ID Numbers: | HIVBone_K12 |
Study First Received: | April 30, 2012 |
Last Updated: | May 1, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Alabama at Birmingham:
HIV Bone mineral density bone turnover fracture inflammation |
Additional relevant MeSH terms:
Fractures, Bone Wounds and Injuries |
ClinicalTrials.gov processed this record on March 10, 2013