University of Sheffield researchers helped secure FDA approval for a new bone imaging method that could speed up osteoporosis drug trials, meaning new treatments may reach patients faster than ever
University of Sheffield scientists have made a breakthrough that could bring new osteoporosis treatments to patients faster. The US FDA has approved a cutting-edge bone-imaging biomarker as a surrogate measure of fracture risk in clinical trials, the first time such a method has been qualified. By allowing smaller, quicker studies, this breakthrough could transform how osteoporosis medicines are tested and delivered, offering hope to millions living with brittle bones.
FDA qualification: A major step for osteoporosis treatment research worldwide
The US Food and Drug Administration (FDA) has approved a qualified image-based biomarker of bone mineral density (BMD) as a surrogate endpoint for bone fractures in clinical trials for osteoporosis medicines. This decision is expected to shorten clinical trials and speed up patient access to new therapies.
This qualification is the result of a large-scale global research collaboration co-led by experts from the University of Sheffield, Harvard Medical School, and the University of California, San Francisco.
The SABRE Project analysed data from 52 randomised clinical trials involving more than 160,000 patients, which is the most comprehensive dataset assembled for osteoporosis research. The work was delivered through extensive public–private collaboration coordinated by the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium, with statistical guidance from the FDA under the 21st Century Cures Act.
Professor Richard Eastell, Professor of Bone Metabolism at the University of Sheffield, said: “This FDA qualification is a major advance for osteoporosis research and a powerful example of how collaborative science can deliver real-world impact. By helping to establish bone mineral density as a validated surrogate for fracture risk, this work will accelerate the development of new treatments and ultimately help prevent fractures that can profoundly affect patients’ lives.”
This decision is expected to stimulate renewed investment in osteoporosis drug development, with faster access to new therapies reducing fracture rates, improving quality of life for ageing populations, and easing pressures on healthcare systems.
Osteoporosis affects millions of people worldwide
Osteoporosis is a chronic condition that weakens the bones and increases the risk of fractures. These fractures can lead to chronic pain, disability, and loss of independence. It affects up to 500 million people worldwide but remains widely under-diagnosed.
Traditionally, osteoporosis drug trials have relied on fracture outcomes, which means waiting to see if patients break bones. This requires very large patient populations and years of follow-up. By confirming that changes in bone mineral density (BMD), a measure of bone strength, reliably predict fracture risk, the FDA’s decision allows future trials to use BMD as a surrogate endpoint, or substitute measure, for fractures. This will enable studies to be smaller, faster, and more affordable, accelerating the development of innovative treatments.
