Fracture Risk Assessment Calculator Represents Major Breakthrough in the Prevention of Bone Fractures

A newly developed application represents a key breakthrough in the early intervention to prevent bone fractures. It identifies patients who have a high risk of experiencing fractures over a period of 10 years but who have not yet crossed the diagnostic threshold for osteoporosis. Utilizing this application, countries can then determine a country-specific intervention threshold, where pharmacologic treatment is justified for fracture prevention.

The WHO Collaborating Center for Metabolic Bone Diseases, located at the University of Sheffield Medical School, UK, under the leadership of Prof. John Kanis, developed the fracture risk assessment (FRAX) as a tool to help healthcare providers identify and proactively treat patients with a high risk of bone fractures due to low bone mass and other risk factors. Hologic, Inc. (Bedford, MA, USA), a leading provider of diagnostic and digital imaging systems directed towards women's health, has built this technology into its Discovery and Explorer bone densitometer systems.

Hologic announced it is the first diagnostic medical device manufacturer to receive U.S. Food and Drug Administration clearance to incorporate the World Health Organization (WHO) FRAX 10-year fracture risk calculator into its bone densitometer systems.

While the T-score remains the standard for diagnosing osteoporosis, FRAX enables healthcare providers to identify patients with a high risk of experiencing bone fractures within a period of 10 years. By combining 11 of the highest risk factors, including age, personal history of factures, and family history of fractures, plus country-specific life expectancy and country-specific fracture data, FRAX identifies patients at high risk of fracture but who would not be candidates for preventative therapy using the conventional T-score.

"The prompt integration of the FRAX calculator into our products exemplifies Hologic's on-going commitment to provide the most up-to-date technology combating osteoporosis, a critical women's health issue,” said Kevin Wilson, Ph.D., scientific director at Hologic. "By incorporating the FRAX calculator into our bone densitometer systems, we dramatically alter and improve the way patients are evaluated and treated for potential bone fractures. In the United States, the National Osteoporosis Foundation in collaboration with many other physician groups has issued guidelines recommending that a patient's 10-year fracture risk calculated with FRAX be used by physicians to determine whether pharmacological treatment is indicated for prevention of bone fractures.”

Jack Cumming, chairman and CEO of Hologic said, "We want to give our customers the very best tools to identify for treatment those patients at risk for costly fractures. Our mission is to greatly reduce the medical, emotional, and economic burden that osteoporosis bears on this country, and indeed the world.”

FRAX is based on individual patient models that integrate the risks associated with clinical risk factors as well as bone mineral density (BMD) at the femoral neck to calculate a patients 10-year fracture risk. The FRAX model has been developed from studying population-based cohorts in Europe, North America, Asia, and Australia.

"FRAX enables healthcare providers to identify patients who otherwise would go untreated until they experienced a bone fracture,” added Mr. Wilson. "An estimated 200 million women suffer from osteoporosis worldwide. Even more alarming, 10-20% of those who suffer a hip fracture die within the first year, and up to 25% of hip-fracture patients require long-term nursing home care. The early incorporation of FRAX into our densitometers demonstrates our commitment to enhance women's health through earlier and better detection.”

Hologic is a leading developer, manufacturer, and supplier of diagnostics products, medical imaging systems, and surgical products that serve the healthcare needs of women. Hologic's core business units are focused on breast health, diagnostics, gynecology, surgical, and skeletal health.


Related Links:
WHO Collaborating Center for Metabolic Bone Diseases
Hologic