In order to diagnose osteoporosis, doctors commonly use X-rays to measure an individual’s bone mineral density.
Although this is standard procedure for helping patients pursue preventive care for the condition, Ohio University scientists say that it also poses a big problem. Measuring bone density is actually a poor predictor of which patients will experience osteoporosis-related bone fractures. One study found that 96 percent of women diagnosed with osteoporosis did not fracture, while 81 percent of women who suffered fractures had been diagnosed as not having the condition.
Although clinicians are aware of the current system’s flaws, “there’s no medical device to replace it,” said Anne Loucks, an Ohio University professor of biological sciences who conducts research on the impact of diet and exercise on bone health.
An interdisciplinary team of medical scientists, engineers, physical therapists and entrepreneurs at Ohio University are hoping to change that with the development of a new system designed to offer a better chance for people with weak bones to get the treatment they need.
The university’s Innovation Strategy program has allocated $875,000 for the team to advance the project, which aims to create a sophisticated prototype of a device that uses vibration technology to measure bone stiffness, as well as a software program that can help target treatment at those individuals who are most likely to suffer fractures.
Team leader Brian Clark says that the project is a good fit for the Innovation Strategy, which the institution launched last year to foster novel, multidisciplinary initiatives in research, creative activity, teaching and university operations.
“This work is promising,” said Clark, a professor in the Heritage College of Osteopathic Medicine and the executive director of the Ohio Musculoskeletal and Neurological Institute.
For almost 40 years, scientists have understood that bone stiffness is an accurate predictor of bone strength, said Lyn Bowman, a research assistant professor in the Department of Biological Sciences. However, the medical community has been unable to find a way to measure stiffness and determine how easily a patient’s bone might break. This led to the development of measurements of bone mineral density as an alternative.
The Ohio University team chose to examine how a technology outside of the medical field might offer a solution. Over the last 30 years, engineers have used vibration analysis to identify bridges that might collapse or components in a computer that might break, Bowman said.
“Vibration analysis is a widely practiced engineering technology now,” explained Bowman, an engineer with industry experience.
Although some medical research has been done with vibration analysis, he is unaware of any commercial medical products that employ it, he said.
Working in the Loucks laboratory, Bowman and other university researchers have improved the Mechanical Response Tissue Analysis (MRTA) vibration analysis technique to measure bone stiffness. The team has filed for a patent on their improvements of the process.
To undergo testing, a patient lies down in the device and raises an arm, resting the wrist on a support. A mechanical probe is placed against the skin over the ulna bone, which runs on the outside of the arm below the little finger. The probe vibrates, and the system captures data to determine the level of bone stiffness.
The process is noninvasive, unlike a competing technology emerging on the market, which requires clinicians to hammer a needle into a bone to test it, the team said.
In comparison, the MRTA device only vibrates against a patient’s skin.
“It feels similar to an electric razor—that’s the type of shaking involved,” Bowman explained.
The team has developed two prototypes of the system, testing it on about 75 subjects to date, Loucks said.
With support from the Innovation Strategy funding, the team now will develop a more advanced version of the prototype that could be commercialized and sold to hospitals and clinics.
Applying for Innovation Strategy support also prompted the researchers to reach out to a wider variety of collaborators, which, in turn, influenced the direction of the project.
“Some of us had been working together for a while, and the Innovation Strategy gave us an opportunity to bring in new people, which gave us a way to push this project forward,” Loucks said.
The team already had harnessed the expertise of the Russ College of Engineering and Technology through a collaboration with John Cotton, an associate professor of mechanical engineering and biomedical engineering, who provided assistance with analyzing bone images. The researchers also recruited Jundong Liu, an associate professor of electrical engineering and computer science, who has expertise in ultrasound images. Jim Zhu, a professor of electrical engineering and computer science who has developed flight navigation and control systems for airplanes, now is helping the team integrate all of its technical components into a comprehensive system.
Also on the team are physical therapy faculty members Gary Chleboun and Betty Sindelar in the College of Health Sciences and Professions, who will be assisting with subject testing and ultrasound imaging.
Because the project entails commercializing a technology and getting it licensed for market use, the researchers also drew on the expertise of Robert Silva in the university’s Technology Transfer Office, which manages intellectual property, and Lee Groeschl and Michele Migliuolo of TechGROWTH Ohio, a program housed at the Voinovich School of Leadership and Public Affairs that provides business coaching and early-stage investment.
The entrepreneurs prompted the scientists to think differently about how to commercialize the technology for the marketplace, Loucks and Bowman said.
“Lee (Groeschl) made us realize that this is not just about the sale of instruments, but the value of the diagnosis we can make with them,” Bowman said.
The team now is developing an informatics system that can communicate with the devices in medical settings, gathering and aggregating data in order to make the most accurate diagnoses for patients, Bowman explained.
After the Ohio University team refines its computer software system and prototype, it will conduct more research on subjects in Athens and at the OhioHealth Research & Innovation Institute in Columbus, where the team has been offered dedicated space.
“This will allow us to conduct a pivotal clinical study using their patients,” Clark said.
Laura Rush, executive director of the Heritage College’s Clinical and Translational Research Unit, will assist with recruiting patients for the study at both the Athens and the OhioHealth Columbus sites.
“OhioHealth strives to be on the forefront of advancing healthcare, and our collaborative relationship with the Ohio University Heritage College of Osteopathic Medicine on this project demonstrates how our organizations are jointly committed to bring the most innovative treatments to our patients,” said John Niles, corporate director for OhioHealth Research & Innovation Institute.
The project has the potential to make a significant impact on the treatment of osteoporosis and prevention of bone fractures, the team noted. Because the current system of diagnosis is not efficient, the cost of treating patients right now is very high, Bowman said. Clinicians provide preventive treatment to many patients who are unlikely to ever experience a fracture, the Ohio University team said, while others at high risk go undetected and untreated.