Trial Outcomes & Findings for Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX (NCT NCT01998737)

NCT ID: NCT01998737

Last Updated: 2017-09-21

Results Overview

The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.

• Recruitment status: COMPLETED
• Target enrollment: 1011 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2017-09-21

Participant Flow

Participant milestones

Measure	Women Under Osteoporosis Suspicion Subjects with at least one risk factor for osteoporotic fracture.	Healthy Women In healthy group females without risk factors for fracture or diseases affecting bone health were recruited.
Overall Study STARTED	911	100
Overall Study COMPLETED	888	100
Overall Study NOT COMPLETED	23	0

Reasons for withdrawal

Measure	Women Under Osteoporosis Suspicion Subjects with at least one risk factor for osteoporotic fracture.	Healthy Women In healthy group females without risk factors for fracture or diseases affecting bone health were recruited.
Overall Study Corrupted database	23	0

Baseline Characteristics

Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX

Baseline characteristics by cohort

Measure	Women Under Osteoporosis Suspicion n=888 Participants	Healthy Women n=100 Participants	Total n=988 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	453 Participants n=5 Participants	74 Participants n=7 Participants	527 Participants n=5 Participants
Age, Categorical >=65 years	435 Participants n=5 Participants	26 Participants n=7 Participants	461 Participants n=5 Participants
Age, Continuous	65.3 years STANDARD_DEVIATION 7 • n=5 Participants	61.6 years STANDARD_DEVIATION 6.6 • n=7 Participants	64.9 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	888 Participants n=5 Participants	100 Participants n=7 Participants	988 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	888 Participants n=5 Participants	100 Participants n=7 Participants	988 Participants n=5 Participants
Region of Enrollment Finland	888 participants n=5 Participants	100 participants n=7 Participants	988 participants n=5 Participants
Weight	64.2 kg STANDARD_DEVIATION 9.9 • n=5 Participants	65.5 kg STANDARD_DEVIATION 9.2 • n=7 Participants	64.4 kg STANDARD_DEVIATION 9.9 • n=5 Participants
Height	161.5 cm STANDARD_DEVIATION 6.1 • n=5 Participants	162.3 cm STANDARD_DEVIATION 6.1 • n=7 Participants	161.5 cm STANDARD_DEVIATION 6.1 • n=5 Participants

PRIMARY outcome

Timeframe: 3 years

The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.

Outcome measures

Measure	Women Under Osteoporosis Suspicion n=888 Participants As defined in the protocol	Healthy Women n=100 Participants As defined in the protocol
Sensitivity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis	93.7 percentage of true positives	100 percentage of true positives

PRIMARY outcome

Timeframe: 3 years

The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.

Outcome measures

Measure	Women Under Osteoporosis Suspicion n=888 Participants As defined in the protocol	Healthy Women n=100 Participants As defined in the protocol
Specificity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis	81.6 percentage of true negatives	93.8 percentage of true negatives

SECONDARY outcome

Timeframe: 3 years

The previously determined thresholds have been applied. The results show amount of subject whose DI value is between the thresholds. These subjects would need DXA measurement to verify diagnosis.

Outcome measures

Measure	Women Under Osteoporosis Suspicion n=888 Participants As defined in the protocol	Healthy Women n=100 Participants As defined in the protocol
Number of Participants That Would Require Additional DXA Examination to Confirm Diagnosis	288 Participants	27 Participants

Adverse Events

Women Under Osteoporosis Suspicion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Women

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

CTO

Bone Index Finland Ltd.

Phone: +358 45 896 2650

Email: janne.karjalainen@boneindex.fi

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place