Clinical trial: Radio-frequency Identification (RFID) Osteoporosis Pilot Study (NCT03385941)

Eligibility criteria:
Inclusion Criteria:

        In osteoporotic patients:

          -  50-80 years of age

          -  Established diagnosis of osteoporosis, based on prior dual energy x-ray absorptiometry
             (DXA) scan with T-score <-2.0 at any site and/or history of fragility fracture

        In healthy controls:

          -  27-40 years of age

          -  Female

        Exclusion Criteria:

        In osteoporotic patients:

          -  Current or recent (within 2 years) use of osteoporosis medications including
             bisphosphonates, hormone replacement therapy, selective estrogen receptor modulators,
             teriparatide, denosumab, calcitonin, or strontium

          -  Pregnancy or breastfeeding within the past 2 years

          -  Any medical or psychiatric condition or situation that would compromise subject
             safety, informed consent/assent, or data quality

        In healthy controls:

          -  History of significant cardiac, renal, pulmonary, hepatic, or malignant disease, or
             current alcohol or illicit drug abuse

          -  Current diagnoses known to effect bone metabolism, including cystic fibrosis,
             diabetes, osteoporosis, amenorrhea >3 months (in menstruating women who are not taking
             oral contraceptives or have an IUD), hyperthyroidism, hyperparathyroidism, Paget's
             disease, kidney stones, chronic inflammatory diseases, malabsorptive disorders,
             malnutrition or eating disorder, endocrine disorders (growth disorder, Cushing
             syndrome), prolonged immobility, and skeletal dysplasias

          -  History one or more pathologic fracture, or greater than four total lifetime
             non-digital, non-facial fractures

          -  Cumulative lifetime use of oral glucocorticoids for greater than 2 months

          -  Current or previous use of medications known to affect bone metabolism including
             hormone replacement therapy, anti-estrogens, bisphosphonates, calcitonin, lithium,
             suppressive doses of levothyroxine, or anticonvulsants.

          -  Pregnancy or breastfeeding within the past 2 years

          -  BMI less than 18.5 or greater than 30 kg/m2.

          -  Any medical or psychiatric condition or situation that would compromise subject
             safety, informed consent/assent, or data quality
Female
Accepts Healthy Volunteers
Subject must be at least 27 Years old.
Subject must be at most 80 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