Clinical trial NCT01591252: Fracture and Bone Mineral Density in HIV+ Patients Recently Started on Antiretroviral Therapy (ART)
Official title: Fracture and Bone Mineral Density in HIV+ Patients Recently Started on Antiretroviral Therapy (ART)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Osteoporosis
Keywords: HIV
Bone mineral density
bone turnover
fracture
inflammation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2012-05-03
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For primary outcomes: 1917 Clinic cohort. For secondary outcomes: Medicare sample.

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.


Eligibility 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

Primary outcomes:
measure: Bone Mineral Density
timeFrame: 1 year
Secondary outcomes:
measure: Fracture in HIV
timeFrame: 10years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Amy H. Warriner, MD
role: PRINCIPAL_INVESTIGATOR
References: