Clinical trial NCT03878732: Bindex for Osteoporosis Diagnostics
Official title: Bindex for Osteoporosis Diagnostics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: Bone Index Finland Ltd
Sponsor class: INDUSTRY
Collaborators: name: New Mexico Clincial Research & Osteoporosis Center, Inc.
First posted: 2019-03-18
Enrollment: 293
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Random sample of eligible female subjects who are being treated at collaborating clinic.

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Sensitivity and specificity of DI
timeFrame: 3/11/2019-11/29/2019
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: New Mexico Clincial Research & Osteoporosis Center, Inc.
state: New Mexico
Study officials:
affiliation: Bone Index Finland Ltd
name: Janne Karjalainen
role: STUDY_CHAIR
References: