Clinical trial: Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX (NCT01998737)

Eligibility criteria:
Osteoporosis suspicion

        Inclusion Criteria:

          -  Age: 50 - 59 years (n = 500) and 60-79 years (n = 500).

          -  Post-menopausal status.

          -  At least one of the clinical risk factors for fracture:

               -  Low body mass index (< 19kg/m2)

               -  Previous fragility fracture

               -  Parental history of hip fracture

               -  Glucocorticoid treatment (≥ 5mg prednisolone daily or equivalent for 3 months or
                  more)

               -  Current smoking

          -  Alcohol intake 3 or more units daily

          -  Causes of secondary osteoporosis:

               -  Untreated hypogonadism

               -  Inflammatory bowel disease

               -  Prolonged immobility

               -  Organ transplantation

               -  Type 1 and type 2 diabetes

               -  Thyroid disorders

               -  Chronic obstructive pulmonary disease

          -  A Physician has referred the woman to axial DXA investigation.

        Exclusion Criteria:

          -  Treatment: osteoporosis medication.

          -  Obesity: body mass index BMI > 30kg/m2

          -  a refusal to participate in the study

        Healthy

        Inclusion Criteria:

          -  Age: 50 - 59 years (n = 50) and 60-79 years (n = 50).

          -  Post-menopausal status.

          -  No diseases or treatments which may affect to bone health.

        Exclusion Criteria:

          -  Treatment: osteoporosis medication.

          -  a refusal to participate in the study

          -  Obesity: body mass index BMI > 30kg/m2
Female
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 79 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? Entailment