NBHA commends FDA for continuing investigation of bisphosphonate treatment for osteoporosis

May 11 2012

In response to today's Perspective pieces published in the New England Journal Of Medicine, the National Bone Health Alliance (NBHA), a public-private partnership bringing together the expertise and resources of its 42 members from the private and non-profit sectors to collectively advance bone health and prevent disease, commends the U.S. Food and Drug Administration (FDA) for continuing to investigate the risks and benefits of long-term bisphosphonate treatment. As recommended in the articles, NBHA encourages patients to talk with their healthcare providers about the risks and benefits of bisphosphonate and other osteoporosis treatments as well as their individual risk factors for osteoporosis and broken bones in order to determine the appropriate method and length of treatment.

"Members of the public and healthcare professionals alike have been looking for clarity regarding the appropriate length of bisphosphonate treatment," said Sundeep Khosla, MD, Chair, National Bone Health Alliance, Immediate Past President, American Society for Bone and Mineral Research and Professor of Medicine and Physiology and Associate Dean for Research, Mayo Clinic, Rochester, Minnesota. "We know that patients have to be evaluated and monitored individually to determine their individual risk versus benefit before starting on or continuing bisphosphonate treatment and we are happy to see the FDA acknowledge that each patient's needs are different. The NBHA's ultimate goal is to protect the two million Americans who suffer broken bones each year due to osteoporosis from suffering a second and potentially more devastating fracture."

The two million fractures that occur in the U.S every year cost the healthcare system $19 billion, yet only 21 percent of women age 67 and above who break a bone receive a follow-up test or treatment for osteoporosis. The number of fractures is expected to rise to three million per year and $25 billion in annual costs by 2025. Fractures have a negative impact on quality of life, can cause physical and functional limitations and affect longevity, particularly for patients with hip and spine fractures. In fact, breaking a hip more than doubles a woman's risk of early death.

NBHA urges patients to consult with their healthcare professional about their individual risk factors before determining the best course of treatment. The risks and benefits of bisphosphonate treatment favors treating patients at high risk for fracture, including those who have suffered a previous hip or spine fracture due to osteoporosis or those with a bone mineral density (BMD) score of less than -2.5.

"As suggested by the FDA's ongoing analysis, giving some patients intermittent drug holidays may be appropriate clinical practice," said Robert Recker, MD, MACP, FACE, Vice Chair, National Bone Health Alliance, President, National Osteoporosis Foundation and Director, Osteoporosis Research Center Creighton University, Omaha, Nebraska.   "While the case for drug holidays is suggested, we first want to address the under-treatment of osteoporosis and encourage the public to talk with their healthcare professionals to determine if they are at-risk for osteoporosis and if therapy is appropriate to help them prevent fracture.  Treatment plays an important role in stopping bone loss and preventing broken bones. And with the number of osteoporotic fractures that occur annually exceeding the incidence of heart attacks, stroke and breast cancer combined, the need for effective treatment to prevent fractures has never been more clear."

NBHA and its member organizations issued statements today noting that bisphosphonate and other treatments are highly effective in the right patients and that patients should not discontinue use of these or any other osteoporosis medicines without speaking to their healthcare professional. Studies have found that bisphosphonates reduce the risk of a broken hip in people with osteoporosis by 50 percent or more, and also reduce the risk of other broken bones, making it clear that bishosphonate treatment is effective in preventing fractures.

To draw attention to the fact that two million fractures occur in the U.S. annually and represent the most significant risk factor for osteoporosis, NBHA has launched a national awareness campaign to make the connection between fractures and osteoporosis. With the theme "2Million2Many,"  the campaign issues a strong and clear call to action that anyone over 50 years of age who fractures should talk with their health care professional about their risk for osteoporosis, consider getting a bone density test and pursuing treatment to prevent osteoporosis and broken bones, if appropriate.