Clinical Evaluation & Recommendations for use

TBS iNsightTM has been evaluated in more than 100 peer-reviewed publications worldwide and on more than 75,000 patients.

TBS has been integrated in 2015 into International and local recommendations: 2015 ISCD Official Position Statements1, ESCEO recommendations2 and DVO Guidelines3.

Some of the key findings have been conveniently summarized in recent review articles published by a group of international bone experts:4, 5, 6

  • TBS is independent and complementary to lumbar spine BMD;
  • TBS is associated with fracture risk, in women, in men and in patients with special conditions affecting bone metabolism (rheumatoid arthritis, endocrine diseases or long-term use of glucocorticoids therapy);
  • TBS fracture risk prediction ability is equal to lumbar spine BMD;
  • TBS is unaffected by the presence of osteophytes – a common artifact in late postmenopausal patients and those presenting with osteoarthritis;
  • TBS is reproducible: the short-term reproducibility of TBS determinations has been reported in several studies with values ranging from 1.1%-1.9% C.V.;
  • TBS gives lower values in women and in men with previous fragility fractures than their non-fractured counterparts;
  • TBS gives lower values in women and in men with previous fragility fractures, but in whom BMD does not indicate osteoporosis or even osteopenia;
  • TBS can assist physicians in monitoring the response to treatments over time;

A summary of pivotal studies used in this review appears in the Table below.

Study summary-Jan2016

 Summary of key clinical studies evaluating TBS iNsight

Click to enlarge Table: Studies Summary – January 2016


 References
  1. ISCD (International Society for Clinical Densitometry): Fracture risk prediction by Non-BMD DXA Measures: the 2015 ISCD Official Positions Part 2: Trabecular Bone Score, Silva et at., JCD 2015.
  2. ESCEO (The European Society for Clinical and Economic Aspects of Osteoporosis and osteoarthritis): Trabecular Bone Score (TBS) as a new complementary approach for osteoporosis evaluation in clinical practice, Harvey et al., Bone 2015.
  3. DVO: Dachverband Osteologie – German Osteology Society.
  4. Silva BC, et al, Trabecular Bone Score: A non-invasive, analytical method based upon the DXA image. J Bone Miner Res 2014; 29(3): 518-530.
  5. Ulivieri FM, et al, Utility of the trabecular bone score (TBS) in secondary osteoporosis. Endocrine 2014 Nov;47(2):435-48
  6. Kolta S, et al, TBS result is not affected by lumbar spine osteoarthritis. Osteoporos Int. 2014 Jun; 25(6):1759-64.