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Study Description

Serum total testosterone, free testosterone and sex hormone binding globulin (SHBG) were measured in women attending Offspring Exam 7 (1998-2001) and Generation 3 Exam 1 (2002-2005). Liquid chromatography tandem mass spectrometry was used to measure total testosterone level as described previously (Sattler FR et al., 2009; Sir-Petermann T et al., 2009; Vesper HW et al., 2008). The sensitivity of the assay was 2 ng/dL, and inter-assay CV 17.9% (low pool), 8.2% (mid pool), and 13.4% (high pool), respectively, in samples with testosterone concentrations of 10.5, 20.9, and 46.8 ng/dL. Serum SHBG levels were measured using an immunofluorometric assay (DELFIA-Wallac, Inc., Turku, Finland). The intra-assay CVs were 8.3%, 7.9%, and 10.9% in the low, medium, and high pools (Bhasin S et al., 2000; Bhasin S et al., 2005). Free testosterone was calculated by using the law of mass action equation (Vermeulen A et al., 1999).

In 1948, researchers recruited men and women from the town of Framingham, Massachusetts, beginning the first round of extensive physical examinations and lifestyle interviews that would later be analyzed for common patterns related to CVD development.

Initially, the Framingham Heart Study enrolled 5,209 men and women from the Framingham area who were between the ages of 28 and 62 years. Beginning in 1971, the Framingham Heart Study enrolled 5,124 men and women, who were either offspring of the original cohort or spouses of those offspring. In 2002, 4,095 third generation participants (men and women) were enrolled.

During each clinic exam cycle, the participants undergo a detailed examination including physical examination, medical history, laboratory testing, and electrocardiogram. Over the years, other tests (that may not be performed at every exam cycle) have included pulmonary function, lifestyle, physical function, cognitive function questionnaires, and various noninvasive cardiovascular tests including echocardiograms. The content of each exam cycle differs for Original, Offspring and Generation 3 cohorts and can be found in the Exam Cycle Protocol Manuals.

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Publicly Available Data
Study Inclusion/Exclusion Criteria

Women attending Offspring Exam 7, Generation 3 Exam 1, who provided a blood sample for sex hormone measurement were included.

Study History

The Generation 1 (or Original) cohort Exam 1 took place between 1948 and 1953. Biennial exams have continued to the present. Exam 29 took place between 2006 and 2007. Exam 30 began in 2008.

The Generation 2 (or Offspring) cohort Exam 1 took place between 1971 and 1975. This cohort on average has been examined every three to four years. However, there was an eight year gap between Exam 1 and Exam 2 and a seven year gap between Exam 7 and Exam 8. Exam 8 took place between 2005 and 2008.

The Generation 3 cohort Exam 1 took place between 2002 and 2005. Exam 2 began in 2008.

The New Offspring Spouse cohort Exam 1 took place between 2003 and 2005. Exam 2 began in 2008.

Selected Publications
Diseases/Traits Related to Study (MeSH terms)
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Study Attribution
  • Principal Investigator
    • Andrea Coviello, MD. Boston University School of Medicine, Boston, MA, USA.
  • Co-Investigators
    • Shalender Bhasin, MD. Boston University School of Medicine, Boston, MA, USA.
    • Vasan Ramachandran, MD. Boston University School of Medicine, Boston, MA, USA.
    • Joanne Murabito, MD. NHLBI and Boston University's Framingham Heart Study, Framingham, MA, USA; Department of Medicine, Boston University School of Medicine, Boston, MA ,USA.
  • Funding Source
    • R01-HL094755-01A2. National Institutes of Health, Bethesda, MD, USA.