Advice

Summary

Summary

  • The technology described in this briefing is Bindex, a portable pulse‑echo ultrasound device used to help make decisions on the investigation and treatment of osteoporosis.

  • The innovative aspects are that it is pocket sized and can be connected to and used with any laptop or desktop computer's USB socket. Unlike other quantitative ultrasound that measures sound speed and attenuation in the heel, Bindex makes measurements of the tibia applying thresholds of 90% sensitivity and specificity compared with axial dual‑energy X‑ray absorptiometry (DXA), to help with decisions on further tests and treatment for osteoporosis.

  • The intended place in therapy would be to use Bindex alongside current algorithmic fracture risk assessment tools (FRAX or QFracture). If these suggest an intermediate or high risk of osteoporosis fracture, Bindex could be used to determine whether referral for DXA scan is needed (in the case of confirmed intermediate risk) or not (if low risk). Treatment could be considered for those at high fracture risk or high risk for osteoporosis as measured with Bindex.

  • The main points from the evidence summarised in this briefing are from 2 diagnostic accuracy studies (1 US and 1 Finnish), including a total of 1,127 women in primary care. The studies show reasonable agreement for osteoporosis risk when determined in women with intermediate risk using FRAX and Bindex compared with FRAX and DXA.

  • Key uncertainties around the evidence are that there are no prospective studies showing the effect of Bindex on the need for DXA scans, and limited data on the correlation between tibial bone thickness and femoral bone mineral density. Also, the Bindex density index threshold values are only validated in women of white European family origin, which may limit the generalisability of the results.

  • The cost of Bindex is based on the software licensing needed. This includes buying the device itself. A licence per computer varies by number of analyses needed: £4,000 for 300 analyses, £6,000 for 500 analyses and £10,000 for 1,000 analyses.