Bindex for Osteoporosis Diagnostics

Currently, the diagnosis of osteoporosis is based on the measurement of bone mineral density (BMD), using axial dual energy X-ray absorptiometry (DXA) of the hip and/or the lumbar spine at special healthcare.

Application of diagnostic thresholds determined against BMD have been suggested by International Society for Clinical Densitometry (ISCD) for use with peripheral bone densitometry devices (90% sensitivity and 90% specificity). These thresholds have been determined and validated for Bindex in Caucasian female population.

This study focuses on clinical validation of the ultrasound device (Bindex®, Bone Index Finland Ltd., www.boneindex.com) device and Density Index (DI), a diagnostic parameter reported by Bindex. The predetermined thresholds for DI will be evaluated by measuring 70 osteoporotic and 70 healthy patients with Bindex and DXA in each selected patient groups. The feasibility of DI for diagnostics of osteoporosis in these groups will be assessed.

Inclusion criteria

for all:

• Postmenopausal status
• Age at 50 years or over
• Caucasian or Hispanic race (number shall be controlled, 140 in each group)
• Body mass index (BMI < 35)

Additional criteria for Osteoporotic group

• T-Score (NHANES database) -2.5 or lower at femoral neck or total femur

Additional criteria for non-osteoporotic group

• T-Score (NHANES database) > -2.5 at femoral neck or total femur

Exclusion criteria

for non-osteoporotic groups (Hispanic or Caucasian)

• Previous osteoporosis diagnosis
• Previous or current use of anti-fracture medication