Bindex for Osteoporosis Diagnostics

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03878732
Study type	Observational
Source	Bone Index Finland Ltd
Contact
Status	Completed
Phase
Start date	March 11, 2019
Completion date	February 7, 2020

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03931109` - Circulating miRNA in Primary Hyperparathyroidism
Not yet recruiting	`NCT03232476` - Effect of Mechanical Loading With PTH on Cortical Bone	Phase 4
Completed	`NCT02884401` - Peri-implant Bone Changes in Post-menopausal Osteoporotic Women	N/A
Completed	`NCT00073190` - Patient- and Physician-Based Osteoporosis Education	Phase 1
Completed	`NCT00402441` - Risedronate in the Prevention of Osteoporosis in Postmenopausal Women	Phase 4
Completed	`NCT03710889` - Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption	Phase 3
Completed	`NCT00010712` - Effects of Black Cohosh on Menopausal Hot Flashes	Phase 2
Recruiting	`NCT05058976` - Romosozumab Use to Build Skeletal Integrity	Phase 4
Active, not recruiting	`NCT05405894` - Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation
Recruiting	`NCT03337971` - Nutritional Supplement and Bone Health in Post-Menopausal Women	N/A
Completed	`NCT03701113` - Milk Protein and Bone Health in Postmenopausal Women	N/A
Completed	`NCT01381588` - The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women	N/A
Completed	`NCT00383422` - Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis	Phase 3
Completed	`NCT00549965` - Satisfaction and Compliance of Risedronate in PMO	Phase 4
Completed	`NCT00035256` - Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis	Phase 4
Completed	`NCT01386281` - Julina Post-marketing Surveillance for Climacteric Symptoms in Japan
Completed	`NCT05266261` - Use of Ibandronate in Diabetic Patients	N/A
Recruiting	`NCT04964388` - Effect of GLP-1 Receptor Agonists on Trabecular Bone Score	Phase 2
Active, not recruiting	`NCT03623633` - Comparative Antiresorptive Efficacy Discontinuation of Denosumab	Phase 4
Recruiting	`NCT05575167` - Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)