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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01591252

Enrollment

200

Registered

2012-05-03

Start date

2012-04-30

Completion date

2014-09-30

Last updated

2016-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Osteoporosis

Keywords

HIV, Bone mineral density, bone turnover, fracture, inflammation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

19 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Bone Mineral Density	1 year	Change in BMD after 1 year

Secondary

Measure	Time frame	Description
Fracture in HIV	10years	Fracture incidence in HIV+ vs. HIV- in Medicare sample

Countries

United States

Outcome results