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
  Purpose

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
HIV
Osteoporosis

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
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591252

Locations
United States, Alabama
UAB
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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
ClinicalTrials.gov Identifier: NCT01591252     History of Changes
Other Study ID Numbers: HIVBone_K12
Study First Received: April 30, 2012
Last Updated: December 3, 2013
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
Osteoporosis
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 26, 2014