TBS iNsight® – a Novel Osteoporotic Fracture Assessment Diagnostic Tool

Medimaps Group announced that a novel method for improving osteoporotic fracture risk assessment, TBS iNsight^®, is now globally available to clinicians through a distribution partnership with General Electric Healthcare (NYSE: GE). GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world and is the market leader in the development and manufacture of Dual Energy X-Ray Absorptiometry (DXA) bone densitometry systems.

On June 10, 2014, Medimaps Group – developers of the TBS iNsight^® diagnostic tool – and General Electric Healthcare signed a distribution agreement to distribute TBS iNsight^® on a global basis leveraging GE Healthcare’s extensive direct sales and distribution organization.

TBS iNsight^® is a unique, easy-to-use software application that assesses bone texture - an index of bone microarchitecture – which in turn is expressed as the Trabecular Bone Score (TBS). The measurement is performed seamlessly using DXA images acquired from a bone mineral densitometry (BMD) scan. No additional patient scan time or radiation exposure is required and results are easily interpreted by physicians to enable them to better manage patients with high risk of fractures. TBS iNsight® has been cleared for marketing by the U.S. Food and Drug Administration.

Prof. Didier Hans, Chairman and Chief Executive Officer of Medimaps Group states; “It is well documented that 40-50% of osteoporotic fracture occurs in patients who are not determined to be osteoporotic by BMD alone, yet BMD remains the only diagnostic method available to most clinicians. A significant body of literature, including a recent study of over 29,000 women, has demonstrated that TBS, when combined with hip and/or spine BMD and FRAX^® clinical factors, can help improve the prediction of future osteoporotic fracture risk in a clinically meaningful way. We’re very pleased to partner with General Electric Healthcare to bring this valuable new predictive tool for better management of osteoporotic patients across the globe.”

For more information on Medimaps and TBS iNsight^®, please visit www.medimapsgroup.com and www.tbsinsight.com

About Medimaps Group

Medimaps group – a Swiss company founded by a group of clinical practitioners and researchers - is a developer of innovative imaging software used in clinical practice for improved patient management with minimum impact on the workflow of the practitioner. The company has raised several rounds of venture capital to further commercialize TBS iNsight^® in the osteoporosis treatment market and for product development of the TBS iNsight^® tool for optimizing implant surgery in the dental and orthopedic markets.

Contacts

Medimaps Group
Oscar Lazaro, +1 781-492-2012
Chief Commercial Officer
olazaro@medimapsgroup.com

http://www.businesswire.com/news/home/20140909005180/en/Medimaps-Group-appoints-General-Electric-Healthcare-Global#.VVC46fCgseM

TBS Result Not Affected by Lumbar Spine Osteoarthritis

Abstract

The effect of lumbar osteoarthritis on bone density and trabecular bone score (TBS) was evaluated cross-sectionally and prospectively in postmenopausal women. Lumbar spine osteoarthritis was graded according to Kellgren and Lawrence grades. Lumbar osteoarthritis was found to increase lumbar spine bone density, but not TBS.

INTRODUCTION:

Lumbar osteoarthritis overestimates lumbar bone density (areal bone mineral density (aBMD)). A new texture parameter, the TBS, has been proposed. Calculation of aBMD uses grey level value, while TBS uses grey level variation. Therefore, our hypothesis was that TBS is not influenced by lumbar spine osteoarthritis.

METHODS:

Menopausal women participating in osteoporosis and ultrasound (OPUS) study were included. They had an aBMD measurement of the spine and hip at baseline and 6-year visit. TBS was calculated on lumbar spine dual-energy X-ray absorptiometry (DXA) scans in an automated manner. The presence of lumbar osteoarthritis was evaluated on baseline radiographs using Kellgren and Lawrence (K&L) classification. Grades range from 0 to 4. In our study, osteoarthritis was defined by at least K&L grade 2.

RESULTS:

This study included 1,254 menopausal women (66.7 ± 7.1 years). Among them, 727 attended the 6-year follow-up visit. Patients with lumbar osteoarthritis had an aBMD higher than those without lumbar osteoarthritis at the lumbar spine, but not at the hip. However, the aBMD significantly increased in all sites with the grade of K&L. In contrast, spine TBS was not different between patients with and without lumbar osteoarthritis (p = 0.70), and it was not correlated with K&L grade. Spine TBS and aBMD at all sites were negatively correlated with age (p < 0.0001). Body mass index was correlated positively with aBMD and negatively with spine TBS (p < 0.0001). The 6-year change of aBMD was significant in the hip and nonsignificant in the lumbar spine. That of TBS was significant, with a 3.3 % decrease (p < 0.0001), independent of K&L grade (p = 0.28).

CONCLUSION:

In postmenopausal women, lumbar osteoarthritis leads to an increase in lumbar spine aBMD. In contrast, spine TBS is not affected by lumbar osteoarthritis.

 http://www.ncbi.nlm.nih.gov/pubmed/24687386

Trabecular Bone Score

"The trabecular bone score (TBS) is a gray-level textural metric that can be extracted from the two-dimensional lumbar spine dual-energy X-ray absorptiometry (DXA) image. TBS is related to bone microarchitecture and provides skeletal information that is not captured from the standard bone mineral density (BMD) measurement. Based on experimental variograms of the projected DXA image, TBS has the potential to discern differences between DXA scans that show similar BMD measurements. An elevated TBS value correlates with better skeletal microstructure; a low TBS value correlates with weaker skeletal microstructure. Lumbar spine TBS has been evaluated in cross-sectional and longitudinal studies."

"The following conclusions are based upon publications reviewed in this article:
1) TBS gives lower values in postmenopausal women and in men with previous fragility fractures than their nonfractured counterparts;
2) TBS is complementary to data available by lumbar spine DXA measurements;
3) TBS results are lower in women who have sustained a fragility fracture but in whom DXA does not indicate osteoporosis or even osteopenia;
4) TBS predicts fracture risk as well as lumbar spine BMD measurements in postmenopausal women;
5) efficacious therapies for osteoporosis differ in the extent to which they influence the TBS;
6) TBS is associated with fracture risk in individuals with conditions related to reduced bone mass or bone quality."

"Based on these data, lumbar spine TBS holds promise as an emerging technology that could well become a valuable clinical tool in the diagnosis of osteoporosis and in fracture risk assessment."
http://www.ncbi.nlm.nih.gov/pubmed/24443324

FRAX Modified by TBS

FRAX^®, launched by the WHO Collaborating Centre for Metabolic Bone Diseases in 2008, calculates the10-year probability of osteoporotic fracture based on clinical risk factors, including bone mineral density (BMD) as an optional input.

A new feature of the online FRAX risk assessment tool was launched in April 2014. The output of FRAX can now be adjusted for Trabecular Bone Score (TBS™). Calculated by TBS iNsight™ software which installs on existing DXA scanners, TBS is a simple method that estimates fracture risk based on a determination of bone texture (an index correlated to bone microarchitecture). The predictive ability of TBS is independent of FRAX clinical risk factors and femoral neck bone mineral density (BMD) values. Educational information and scientific publications about TBS are available at www.medimapsgroup.com.

By adding the patient’s TBS value after the FRAX calculation, users will get a 10-year probability of risk of hip fracture and major osteoporotic fracture adjusted for TBS. Clinical advantages of using TBS-adjusted FRAX scores include:

• Increased accuracy of fracture prediction in the individual
• Reclassification of  patients’ risk for future fracture above or below an intervention threshold

Following the calculation of FRAX probabilities (at www.shef.ac.uk/FRAX) the TBS value can be manually input by clicking on the TBS button below the calculation results box. Entry of the TBS value, automatically calculated by TBS iNsight™ V.3.0, if installed on your densitometer, produces a ‘FRAX Adjusted for TBS’ score.”

http://www.iofbonehealth.org/news/frax-fracture-risk-assessment-tool-output-can-now-be-modified-tbs