Clinical trial: The Effects of Obesity on Bone Structure and Strength (NCT02629185)

Eligibility criteria:
Inclusion criteria:

        Caucasian

        BMI of 18.5 kg/m2 or above

        Ages 25 to 40 years (and premenopausal if female) or 55 to 75 years (and postmenopausal (at
        least 5 years since last menstrual period) if female)

        Sufficiently mobile to undergo scanning

        Able to remain motionless for the duration of the scans

        Able and willing to participate in the study and provide written informed consent

        Exclusion criteria:

        Previous orthopaedic surgery or fractures which preclude imaging at all sites

        History of any long term immobilization (duration greater than three months)

        High trauma fracture or low trauma fracture less than one year prior to recruitment

        Current pregnancy or trying to conceive

        Delivery of last child less than one year prior to recruitment

        Breast feeding less than one year prior to recruitment

        Pre-diagnosed diabetes mellitus

        History of or current conditions known to affect bone metabolism including:

          -  Diagnosed skeletal disease

          -  Osteoarthritis at study measurement sites

          -  Chronic renal disease

          -  Malabsorption syndromes

          -  Diagnosed endocrine disorders

          -  Hypocalcemia or hypercalcemia

          -  Diagnosed restrictive eating disorder

        Conditions which prevent the analysis of the DXA scans or the interpretation of their
        result

        Use of medications or treatment known to affect bone metabolism including Depot
        medroxyprogesterone or the combined oral contraceptive pill

        Alcohol intake of greater than 21 units per week

        Competitive athlete, defined as participating in competitive sport at amateur or
        professional level

        Markedly abnormal clinical laboratory parameters that are assessed as clinically
        significant by the PI.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 25 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? Contradiction