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CTNPT 001: Fracture case-control study in HIV

A case-control study of novel bone imaging techniques and plasma markers in HIV-infected persons with or without fragility fractures

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About the study

This pilot study will compare bone architecture parameters (structure and strength) in adults living with HIV and compare new tools for measuring bone health to current methods. The study researchers are recruiting adults living with HIV who have had a fracture after their diagnosis and HIV positive adults who have never had a fracture. The two groups will be similarly matched according to age, sex, smoking status, and race. This study is intended to inform the design of a future intervention trial aimed at reversing the accelerated loss in bone strength seen during the first year of antiretroviral therapy.

About the disease/condition

Gradual bone demineralization is a feature of normal aging, with both men and women losing bone at a rate of .5% to 1% per year after age 35. Within individuals living with HIV, however, studies show accelerated losses of bone mineral density (BMD), particularly in the first year after starting highly active antiretroviral therapy (HAART). Measuring BMD is commonly used to assess risks of bone fractures and conditions such as osteoporosis (porous bone), a systemic skeletal diseases characterized by low bone mass and loss of bone tissue.

About the approach

Participants in the study will be scheduled for two or more visits to the clinic and have a set of scans done to measure bone strength and structure as well as a set of blood tests. Study researchers will compare BMD measures to new approaches for measuring bone structures, including blood tests measuring vitamin D, phosphate, calcium and parathyroid hormone levels. The results of this study will inform the design of future clinical trials by helping identify the best tools for assessing bone health and outcome measures for trials aimed at correcting the early decreases in bone strength observed on antiretroviral therapy.

Eligibility criteria

Individuals will be eligible for the study if they meet the following inclusion criteria:

Cases

  • Adult (aged 18 years or older)
  • HIV-1 positive diagnosed by enzyme immunoassay (EIA) and confirmatory Western Blot
  • Not anticipated to initiate or change antiretroviral therapy during the course of the study
  • Had a fracture that was:
    • After diagnosis of HIV
    • From a standing height or less, or from an impact that would otherwise not be expected to result in a clinical fracture; must not clearly be the result of major trauma (eg. motor vehicle collision)

Controls

  • Adult (aged 18 years or older)
  • HIV-1 positive diagnosis by EIA and confirmatory Western Blot
  • Not anticipated to start or change antiretroviral therapy during the course of the study
  • No history of fracture
  • Matched 1:1 with one case patient from any site based on age (within 5 years above or below the case patient age), sex, race (classified simply as Caucasian, Black, or other), and smoking status (smoking versus not smoking at the time of the case patient fracture/control patient archived blood specimen collection)

Main exclusion criteria

  • Pregnancy
  • Enrolled in a study examining the impact of an investigation agent or intervention on bone health

Participating sites

Ontario

Dr. Sharon Walmsley
University Health Network – Toronto General Hospital
Ph: 416-340-3871

Dr. Darrell Tan
St. Michael’s Hospital, Toronto
Ph: 416-864-5568

Additional Information

If you would like more information on this clinical study, please refer to a participating site.

Principal Investigators

Dr. Darrell Tan
St. Michael’s Hospital
Ph: 416-864-5568

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