WASHINGTON, May 9, 2012 – The Food and Drug Administration (FDA) announced today that physicians should reassess patients with osteoporosis who are being treated with a class of drugs called bisphosphonates after three to five years of therapy to determine whether they should continue treatment. Bisphosphonates are a widely prescribed class of drugs that are proven to be effective in reducing common bone fractures in people with osteoporosis and at high risk of fractures. Bisphosphonates include the drugs Aclasta, Actonel, Aredia, Bondronat, Boniva, Didronel, Fosamax, Fosavance, Reclast, Skelid and Zometa.
ASBMR Recommendations to Physicians and Patients
The American Society for Bone and Mineral Research (ASBMR) believes that for the vast majority of patients, bisphosphonates are an important weapon against problems caused by osteoporosis and the benefits outweigh the risk of taking them.
However, ASBMR urges physicians to consider each patient's case individually since the optimal length of bisphosphonate therapy remains unknown and must be considered on a case-by-case basis. Patients whose fracture risk has clearly been reduced by bisphosphonates might be candidates for discontinuing the drug. However, individuals who after three to five years of taking bisphosphonates still have a high risk for fracture may want to remain on the medication because the risks of stopping treatment may not be the best option. For high-risk patients, there is strong data that the drug remains very useful in preventing fractures caused by osteoporosis.
More research is critically needed to help guide patients and their physicians on what to do because major research gaps remain:
- More conclusive data is needed on the safety and effectiveness of taking bisphosphonates for more than three to five years and how bones respond when patients discontinue treatment. In the meantime, the FDA's advice provides important precautions.
- Physicians need more guidance on how to monitor and treat patients who have discontinued bisphosphonate therapy.
- Data is also needed on variation in response to the discontinuation of treatment among different brands of bisphosphonates.
These important research priorities are identified in the May issue of the Journal of Bone and Mineral Research and ASBMR believes they should be the next focus of osteoporosis research.
At least 10 million Americans currently suffer from osteoporosis and another 34 million more have low bone mass, making them more susceptible to osteoporosis. Without intervention, one in two women and one in four men age 50 and older will experience a fracture due to osteoporosis. Many individuals – men and women – do not know they are at risk for the disease. Twenty years ago, physicians had very few treatment options for osteoporosis. Today, many high quality clinical trials have established that bisphosphonates prevent most types of serious fractures and thus are of benefit to millions of patients.
Despite this, osteoporosis is undertreated. Many patients – even those at risk for osteoporosis – are never screened; with the result that osteoporosis goes undiagnosed, is untreated and progresses to debilitating fractures that are dangerous to patients and costly to treat.
ASBMR Offers Webinars on the Scientific Evidence and Management of Patients on Bisphosphonates
To help researchers and physicians understand the implications of the FDA recommendations and factors to consider for patients taking bisphosphonates, ASBMR will host two webinars in the coming weeks.
- The first webinar on the Efficacy and Safety of Long-Term Use of Bisphosphonates for the Treatment and Prevention of Osteoporosis will be held on May 17th and facilitate further discussion of the scientific evidence regarding bisphosphonates. The webinar speakers will include Dr. Theresa Kehoe with the FDA Center for Drug Evaluation, as well as several ASBMR experts.
- The second webinar on Case Studies on the Management of Patients on Bisphosphonates for the Treatment and Prevention of Osteoporosis will be held in late May and facilitate further discussion of the management of patients on bisphosphonates.
To register for either webinar, visit http://www.asbmr.org/Education/Webinars.aspx.
Media Availability
To schedule an interview with an ASBMR expert, including Dr. Sundeep Khosla or Dr. Elizabeth Shane – lead authors of ASBMR Task Force reports issued in 2007 and 2010 on bisphosphonate use and osteonecrosis of the jaw and atypical femur fractures – please contact Sara Knoll at sknoll@burnesscommunications.com or (301)652-1558 or Ann Elderkin at aelderkin@asbmr.org or (202) 367-1161.
About ASBMR:
The American Society for Bone and Mineral Research (ASBMR) is the premier professional, scientific and medical society established to promote excellence in bone and mineral research and to facilitate the translation of that research into clinical practice. The ASBMR has a membership of nearly 4,000 physicians, basic research scientists, and clinical investigators from around the world.
Journal
Journal of Bone and Mineral Research