Age Dependend Diagnostic Thresholds for Osteoporosis Bindex Ultrasonometer
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational [Patient Registry]

Summary: 
      This study is designed for clinical validation of the novel ultrasound device (Bindex®, Bone
      Index Finland Ltd.). In a preliminary study technique has been validated in Finnish elderly
      woman population with 285 healthy and 56 osteoporotic subjects (n = 341 in total).
      Significant and good correlation was observed between Density Index (DI) determined with
      Bindex and femoral bone mineral density determined with DXA (r = 0.65 - 0.70). In addition,
      with determination of 90% sensitivity and specificity thresholds, significant number (65-75%)
      of patients could be diagnosed without additional verification with DXA.

      First, the thresholds for DI will be determined by measuring 70 osteoporotic and 70 healthy
      patients (n = 140) with Bindex and DXA within four decades of age; age 50 to 59 years, age 60
      to 69 years, age 70 to 79 years, and age 80 to 89 years. The feasibility of DI for
      diagnostics of osteoporosis and evaluation of bone mineral density (BMD) will be assessed.
      The thresholds for the BMD estimate obtained with DI will be determined for osteoporotic and
      non-osteoporotic patients. For fracture risk assessment, DI measurements are used to predict
      the outcome of currently available fracture risk assessment tools.

        1. To investigate optimal configuration of ultrasound parameters and patient
           characteristics for prediction of proximal femur and lumbar spine BMD for women in each
           four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.

        2. To develop national diagnostic thresholds for DI in prediction of osteoporosis status
           with a reference female population (American-Caucasian) in each four decades of age; 50
           to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.
    

Detailed description: 
      Data will be stored by Park Nicollet Institute. Only data listed below will be given to the
      research team at Bindex for analyses.

      The data for determination of diagnostic threshold for DI in North American population will
      be analyzed by Bone Index Finland. The data will include following parameters:

        -  Age in years

        -  Weight

        -  Height

        -  Cortical thickness values at each location

        -  Density Index values

        -  Raw data on ultrasound signals.

        -  DXA measurement data

        -  Identification code (Uniquely created identification code given to a subject, does not
           carry any information on subject but enables tracing if needed.)

        -  Data from Appendix A, excluding patient name and medical record number

      Risk factors will be collected in a separate questionnaire (Appendix A).

        1. Name

        2. Medical Record Number

        3. Weight (kg)

        4. Height (cm)

        5. Chair Stand test Can do easily; can do only with difficulty; cannot do

           Risk Factors:

        6. Previous fracture (Skeletal site, age at which fracture occured)

        7. Parent fractured hip (Yes, No)

        8. Current smoking (Yes, No)

        9. Glucocorticoid Use (Yes, No)

       10. Rheumatoid arthritis (Yes, No)

       11. Alcohol 3 or more units per day (Yes, No)

       12. Osteoporosis medication, type (e.g. alendronate, bisphosphonates), start- and end-date
           (Within the past five years)
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Female (American-Caucasian)
      
Keywords: Osteoporosis, diagnosis, ultrasound