Bindex for Osteoporosis Diagnostics

Bone Index Finland

Status: Completed

Conditions: Osteoporosis, Postmenopausal

Treatments: Diagnostic Test: Bindex measurement

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03878732

Bind2301

Details and patient eligibility

About

Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients 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. Bindex ultrasound device has been developed and validated in Caucasian female population. In this study, diagnostic thresholds for density index as determined with Bindex will be evaluated in two different ethnic populations.

Full description

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.

Enrollment: 293 patients

Sex: Female

Ages: 50 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

293 participants in 2 patient groups

Caucasian female

Treatment:

Diagnostic Test: Bindex measurement

Hispanic female

Treatment:

Diagnostic Test: Bindex measurement