Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational [Patient Registry]

Summary: 
      Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture
      risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are
      diagnosed only after several fractures. Furthermore, the progressively aging population will
      increase the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic
      patients are not diagnosed and does not receive treatment for their condition.

      In this study we aim to investigate the strength of Density Index (DI) for prediction of
      proximal femur and lumbar spine BMD as well as determining the diagnostic thresholds for DI
      for osteoporosis diagnostics by using the International Society for Clinical Densitometry
      guidelines. In addition we aim to investigate how many additional women would be identified
      for osteoporosis diagnosis/ treatment based on adding FRAX to Bindex versus adding FRAX to
      DXA.

      The investigators will start and organize a multicenter study in 5 osteoporosis clinics in
      Suomen Terveystalo Healthcare Service Company in Finland. A total of 1100 postmenopausal
      women (age 50 -79 years) will be measured with both axial DXA and Bindex. In addition, the
      FRAX questioinnaire will be asked from everybody attending the study.

      Clinical hypotheses:

        1. Cortical bone thickness is decreased in osteoporosis.

        2. Patient age, weight and height are related to BMD status and therefore are needed in BMD
           estimation (Density Index).

        3. Ultrasound is a safe method in osteoporosis screening and diagnostics for osteoporosis.

        4. Fracture risk factors (FRAX) and point-of-care bone density measurement together have
           significantly higher sensitivity and specificity for osteoporosis/treatment decisions
           than one method alone.
    

Detailed description: 
      The following procedures will be applied

        -  Signing Informed Consent

        -  Filling in the FRAX questionnaire

        -  DXA measurements of the proximal femur and AP spine

        -  Bindex ultrasound measurement of both the tibia and the radius

      Written informed consent is obtained from all subjects before enrolment to the study. All
      patient data is coded, i.e. made anonymous, to conform to personal data protection. The data
      is processed only for study purposes.

      A total of 1100 postmenopausal women (age 50 -79 years) will participate the study. The
      subjects will be divided into two groups: healthy (100 women) and under osteoporosis
      suspicion (1000 women). The groups will be matched by BMI.

      Written informed consent is obtained from all subjects before enrolment in the study. All
      patient data is coded, i.e. made anonymous, to conform to personal data protection. The data
      is processed only for study purposes.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A total of 1100 postmenopausal women (age 50 -79 years) will participate the study. The
        subjects will be divided into two groups: healthy (100 women) and under osteoporosis
        suspicion (1000 women). The groups will be matched by BMI.

        Women for the under osteoporosis suspicion group will be invited from those who have got a
        referral for DXA examination from their doctor.
      
Keywords: Osteoporosis, diagnostics, ultrasound