Challenge
Dual-energy X-ray absorptiometry (DXA) has been used extensively in clinical trials in osteoporosis. DXA is increasingly being used to examine bone density in trials of drugs that could have unwanted effects on bone, and for studies evaluating adipose tissue and muscle – for example studies of obesity, sarcopenia or cachexia. DXA is one of the few truly quantitative imaging techniques, as a numerical output is obtained in the scan and not derived later from the image; it counts the number of photons that are lost as they pass through patients, and bone, fat and muscle absorb X rays differentially. Several clients have sought our support to understand DXA, including DXA platform developers, companies running clinical trials that include DXA read-outs, and core labs looking to expand into the DXA market.
Solution
Alacrita is well-placed to advise on numerous topics within the DXA space. Our medical imaging consultant wrote the book on DXA (Pearson, D. & Miller, C. “Clinical Trials in Osteoporosis” Springer (2007)), and his previous experience – from his PhD work on the ultrasonic assessment of bone to the creation of a new company that was acquired by a medical imaging major – assures he is familiar in metabolic bone disease and the evaluation thereof. Colin has served on numerous clinical advisory boards in which bone densitometry was 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. He has provided guidance on DXA in numerous contexts, to both providers and end-users of DXA-based measurements; these companies specifically seek opinions from him as a thought-leader in DXA. Example DXA consulting assignments include:
Case 1 | An imaging core lab was looking to expand into the growing DXA market. Although they had substantial experience in imaging for clinical trials, they had little experience in DXA. Our DXA consultant provided an overarching view of the DXA business in clinical trials, from both a business and a clinical perspective. He visited the lab and provided them with an understanding of DXA, including its power and its limitations. As DXA is a truly quantitative method, the machines at each clinical trial site need to be standardized using “calibration phantoms”, which act as dummy patients for each individual machine, enabling the development of cross-site standardization protocols. As our consultant’s expertise includes these phantoms (he holds 2 patents relating to their design), his advice on setting up clinical trials was highly valued. After some internal development and design, he provided the client with a tailored plan on how to develop the technology in-house, ensuring the client was able to provide high-quality DXA analysis and take advantage of this lucrative opportunity.
Case 2 | A DXA machine manufacturer approached us seeking advice on their next round of product development. They wanted to ensure that product line extensions are ready for their users in a timely manner, and therefore needed to understand how DXA could be expanded and in which therapeutic areas it could be most useful. Our consultant provided insight into the future pharmaceutical developments for which DXA might have a unique and growing opportunity for use. This analysis required a deep understanding of the pharmaceutical space generally as well as specific knowledge about DXA. He was able to outline the types of software that future clinical trials are likely to want based on his understanding of how the technology could be used, both in bone and other tissues. His analysis provided the client with the insight to be ready for the future; as Wayne Gretsky famously said, “A good hockey player plays where the puck is. A great hockey player plays where the puck is going to be.” Our client is now well-placed, waiting for the upcoming DXA pass.