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8 June 2018

Using DXA in Clinical Trials

Written by Colin G. Miller

 

Problem

Several clients have sought help to understand dual-energy X-ray absorptiometry (DXA), including core labs looking to expand into the DXA market, DXA platform developers, and companies running clinical trials that include DXA readouts.

Osteoporosis clinical studies often use DXA to examine bone density in trials of drugs that could adversely affect bone, as well as studies evaluating adipose tissue and muscle, including studies of obesity, sarcopenia, and cachexia.

Solution

Members of our group have excellent credentials qualifying them to advise on numerous DXA-related topics.

  • Colin Miller and Derek Pearson wrote the book on DXA “Clinical Trials in Osteoporosis,” by Pearson, D. & Miller, C. Springer (2007).

  • Colin Miller has previous experience on the ultrasonic assessment of bone from his PhD thesis and continued a few years later supporting the clinical development for the FDA PMA for the Lunar Achillles ultrasound device.  

  • Colin Miller also served on numerous clinical advisory boards using bone densitometry as a critical measurement, including as a safety signal, such as the trials of the anti-diabetic drugs rosiglitazone and canagliflozin, the anti-acne compound isotretinoin, and drugs to treat endometriosis and fibroids Eligolix or Orilissa).

  • 2 DXA phantom patents are held by Colin Miller:  The bona fide phantom for bone mineral density (BMD) and the variable composition phantom (VCP) for body composition.

Outcome

Guidance has been provided on DXA to both providers and end users of DXA-based measurements who specifically sought their opinion as DXA thought leaders.

Below are specific case studies:

Case 1:

Problem

An imaging core lab with plenty of experience in imaging for clinical trials wanted to expand into the growing DXA market though they had extremely limited experience in DXA. Both a business and a clinical perspective on the DXA market were provided to this client.

Solution

A series of lectures including on-site discussions provided the underlaying concepts of DXA in clinical trials. The quantitative nature of DXA means that the machines for each clinical trial site need to be standardized using “calibration phantoms” to synchronize protocols across all sites. Two patents related to DXA calibration phantom design (the one that has been used in more than a hundred clinical trials is the Bona Fide Phantom) were instrumental in informing the lab visit.

Outcome

The lab highly valued the advice on setting up clinical trials. After some internal development and design, the client was provided with a tailored plan on how to develop the technology in-house, ensuring the client’s ability to provide high-quality DXA analysis and take advantage of this lucrative opportunity. 

Case 2:

Problem

A manufacturer of DXA machines sought advice on their next round of product development. The manufacturer wanted to understand how and for what DXA might be expanded and wanted to make sure any product line extensions would be ready for users in a timely manner.

Solution

Insight was provided to this client into where DXA could be used in development of future pharmaceutical products. Software types that future clinical trials are likely to want were outlined based on an understanding of how the technology could be used, in bone as well as other tissue.

Outcome

Analysis has allowed the company to be ready for the future, and using an ice hockey analogy from Wayne Gretzky, to play “where the puck is going to be.”

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