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Clinical trial

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

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Last updated:25th Nov 2013
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. Clinical hypotheses: - 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.
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Study start date 2013-11-25

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