A team from the Netherlands is the first-ever to pair testosterone and alendronate for the purpose of local bone regeneration. Hoping that their work sets the stage for accelerated healing, the researchers published the results of their lab work, “Sustained release of ancillary amounts of testosterone and alendronate from PLGA coated pericard membranes and implants to improve bone healing,” on May 17, 2021, in the online journal PLOS ONE.
Co-author Jan Gossen, Ph.D., a molecular biologist who is founder and CEO of Osteo-Pharma, a company based in the Netherlands and study co-author explained the uniqueness of this approach to OTW, “The combination of testosterone and alendronate for local bone healing is unique and has not been tested before.”
By designing the treatment as a local drug delivery system, Gossen and his team hypothesized that they could reduce the number of doses required for providing uniform systemic drug delivery, and potentially mitigate serious side effects that can come with systemic exposure.
For this study, Gossen and the team used a novel ultrasonic spray coating for sustained release of ancillary amounts of testosterone and alendronate encapsulated in a polymer—PLGA 5004A.
“In vitro release analysis of collagen membranes and screws showed up to 21 days sustained release of the compounds without a burst release,” wrote the authors. “Subsequent pre-clinical studies in rat and rabbit models indicated that testosterone and alendronate coated membranes and screws significantly improved bone regeneration in vivo.”
“Coated membranes significantly improved the formation of new bone in a critical size calvarial defect model in rats (by 160% compared to controls). Coated screws implanted in rabbit femoral condyles significantly improved bone implant contact (69% vs 54% in controls), bone mineral density (121%) and bone volume (119%) up to 1.3 mm from the implant.”
“We had another paper published late last year where we used the membranes in the mini-pig in a dental defect study,” said Dr. Gossen to OTW. “The main conclusions from both papers are that local release of these compounds results in enhanced and more rapid formation of new bone. In contrast to BMP2 which has been frequently used in the past, our compounds are very cheap and as they are low molecular weight compounds easily diffuse in much larger areas of bone tissue.”
“We are about to start a dental clinical trial. The aim of this study is to show that the use of membranes coated with these bone healing compounds are safe and that it will result in more rapid placement of implants. Obviously, for patients that would be a great advantage as they would be able to have their implants placed within a much shorter timeframe. We are also developing these membranes for orthopedic applications such as fracture healing. Like in the dental study, we aim to show that the use of these membranes will enable shortened time-to-healing.”
