Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX
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|ClinicalTrials.gov Identifier: NCT01998737|
Recruitment Status : Completed
First Posted : December 2, 2013
Results First Posted : August 11, 2017
Last Update Posted : September 21, 2017
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.
- Cortical bone thickness is decreased in osteoporosis.
- Patient age, weight and height are related to BMD status and therefore are needed in BMD estimation (Density Index).
- Ultrasound is a safe method in osteoporosis screening and diagnostics for osteoporosis.
- 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.
|Condition or disease|
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||1011 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
|Women under osteoporosis suspicion|
- Sensitivity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis [ Time Frame: 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.
- Specificity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis [ Time Frame: 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.
- Number of Participants That Would Require Additional DXA Examination to Confirm Diagnosis [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998737
|Jyväskylä, Finland, 40100|
|Kouvola, Finland, 45100|
|Kuopio University Hospital|
|Lahti, Finland, 15110|
|Terveystalo Mikkeli Marski|
|Mikkeli, Finland, 50100|
|Principal Investigator:||Heikki Kröger, MD, PhD||Kuopio University Hospital|
|Study Director:||Janne P Karjalainen, PhD||Bone Index Finland Ltd|
|Study Director:||Ossi Riekkinen, PhD||Bone Index Finland Ltd|