NOF President, Dr. Robert Recker, delivered remarks Friday, September 9 at the joint meeting of the FDA Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committees

ORAL REMARKS – NOF President Robert R. Recker - FDA – September 9, 2011

Good afternoon. I am Dr. Robert Recker, director of the Osteoporosis Research Center at Creighton University in Omaha, Nebraska and am here as president of the National Osteoporosis Foundation, the leading consumer and community-focused health organization dedicated to the prevention of osteoporosis and broken bones.

NOF accepts support from a wide range of diversified sources, including individuals, foundations, government sources and corporations.  I have been a consultant and received research support from industry, personally and through my institution.

Thank you for providing this forum.

Osteoporosis and low bone density affect about 44 million Americans. Without treatment, one in two women and one in four men will break a bone after age 50 because of osteoporosis. These fractures cause death and disability. There are about 350 thousand hip fractures annually in the U.S. About 20 – 25% of people with them die in the year following the fracture, and about 50% of survivors require long term assistance for activities of daily living. Yet many people do not know their risk for the disease, even after they fracture.

Bisphosphonate treatment can reduce the risk of fractures in people with osteoporosis by 40 to 50 percent. In addition, greater compliance with bisphosphonate treatment results in greater reduction in fracture rates. Thus, bisphosphonates often are prescribed for the prevention and treatment of osteoporosis.

Two safety concerns have emerged with bisphosphonates, ONJ and atypical femur fractures. However, less than ½ percent of the osteoporosis patients taking oral bisphosphonates suffer ONJ. Good dental health should be assured before prescribing bisphosphonates, and the ONJ risk should be contrasted with the risk of fracture in patients with osteoporosis.

It should be pointed out that both ONJ and atypical fractures also occur rarely in patients who have never been treated with an osteoporosis drug.

Patients who have fractured or who are at high risk of fracture should be treated with effective medications including bisphosphonates. They should be educated to know the warning signs of ONJ and atypical femur fractures. They should be assessed regularly to determine whether continuation of therapy is appropriate.

NOF strongly believes that for most patients, bisphosphonates are an important weapon against osteoporosis and associated fractures and their benefits outweigh the risks. Potential for the rare adverse events of ONJ and atypical fractures should be weighed against this benefit, patient by patient. If patients have side effects, unusual symptoms or questions about the long-term use of bisphosphonates, they should be encouraged to talk with their healthcare providers. Thank you.

The NOF and sister organizations are considering sponsoring a consensus conference to help clinicians with the clinical dilemmas discussed at this conference.