Polish scientists have developed a bone implant that could improve treatment for patients with weak bones, by delivering drugs directly to fracture sites, project leaders say.
The implant will use zeolites, minerals obtained from coal combustion in power plants, among other materials.
At a press conference in Lublin, Professor Agata Przekora-Kuśmierz, project leader from the Medical University of Lublin, said: “If a severe fracture occurs in a patient suffering from osteoporosis [a bone disease that makes them fragile and more likely to break - ed.], the healing process is very difficult and lengthy; sometimes even impossible due to the ongoing excessive bone degradation processes.”
She added that standard treatment involves administering bisphosphonate drugs, which are poorly absorbed in the gastrointestinal tract. “Patients must take high doses of medications and follow a restrictive diet to increase their absorption,” she said.
The researchers designed the implant to release bisphosphonates directly at the fracture site, but only when cells responsible for bone degradation are excessively active.
Two teams have worked on the implant for nearly three years. The Lublin University of Technology team developed the ceramic base and conducted microstructural and mechanical tests. The Medical University team performed pre-clinical evaluation. Their work has produced nine patent applications and one granted patent.
“The main carrier in this implant is a highly porous zeolite structure,” said Professor Wojciech Franus from the Lublin University of Technology.
He explained that zeolites form naturally through reactions between seawater and volcanic ash but can also be produced in laboratories and industrial plants.
Zeolite structures can be derived from fly ash generated by coal-fired power plants and combined heat and power plants.
They have applications as cement substitutes, in asphalt mixtures, and for removing contaminants.
Franus said zeolites contain calcium ions that support crystallization of apatite, a primary component of bone. “We attach bisphosphonates to the porous zeolite structure, which aid in bone regeneration and are also very sensitive to pH,” he said.
He added that the implant would “selectively and slowly” release the drug once implanted, allowing “to achieve the appropriate medical effect.” The drug is released only when needed, Franus said.
Przekora-Kuśmierz said the implant acts as a scaffold for naturally occurring bone cells. “In the event of excessive activity of bone-degrading cells, a drug will be released to inactivate them,” she said. Regenerated tissue then grows onto the implant, which is gradually replaced by natural bone.
She acknowledged that implants are not a new concept but said the ability of the material to adjust drug release to a patient’s needs is globally innovative.
Work on the implant has been funded by the Polish National Science Centre and has cost PLN 3.5 million. The researchers have applied for additional funding from the Medical Research Agency, with results expected in December. Przekora-Kuśmierz estimated pre-clinical studies could cost PLN 12 million, with clinical trials requiring a similar amount.
“If funding is secured, the material should be ready for human trials within three years. Within six years, the product would be ready for market launch,” she said.
Osteoporosis is a metabolic disease caused by an imbalance between bone formation and degradation, leading to gradual bone loss and increased fracture risk. One in three women and one in five men over 50 will experience an osteoporotic fracture. Current treatments only slow disease progression.
According to the Polish National Health Fund, 2.3 million people in Poland suffer from osteoporosis, including 1.8 million women. Worldwide, the disease affects more than 200 million people. (PAP)
PAP - Science in Poland
pin/ bar/
tr. RL
