Author: Arvin Alvea

IOF Capture the Fracture Webinars

Written on April 1, 2014. Posted in Latest News.

Register to view a series of IOF Capture the Fracture Webinars. These webinars are for healthcare professionals who want to learn more about Fracture Liaison Services.

BISPHOSPHONATES AND ATYPICAL FRACTURES

Written on June 16, 2012. Posted in Position Statements.

We are aware of recent media reports that long-term use of bisphosphonates for osteoporosis (sold under the names of Fosamax [alendronate] and Actonel [risedronate]) may be associated with the occurrence of unusual fractures, most commonly reported to affect the thigh bone.

It is a fact that all medications have risks associated with them. Osteoporosis medications are no exception. Every time a m edication is recommended or prescribed, a car eful weighing of the risks and benefits associated with taking that medication is included.

The concern raised in some recent press reports relates, in part, to two studies presented at the annual meeting of the American Academy of Orthopaedic Surgeons in March 2010. 1 One study, from Columbia University, evaluated bone structure in 111 women, half of whom had been taking bisphosphonates for a minimum of 4 years. Using a research technique called Hip Structural Analysis, the study found that in the early treatment period bisphosphonates improved the structural integrity of bone, but that the effects were diminished with long term use. The second study examined bone biopsies from 12 patients treated with bisphosphonates for an average of 8 years and 9 without bisphosphonate therapy. They found no differences in the architecture between the groups, but the group treated with bisphosphonates had less microscopic variability in bone tissue. Other reports have not seen a definite link between prolonged bisphosphonate use and atypical femoral fractures. Using national observational register-based data from Denmark, the ratio b etween h ip an d s ubtrochanteric/diaphyseal femur f ractures w as i dentical i n alendronate-treated patients and the control cohort even in the limited number of patients who received long-term treatment.2 The other study reviewed data from three large randomized trials and concluded t hat s ubtrochanteric/diaphyseal femur fractures w ere v ery r are, even among women w ho ha d be en treated with bisphosphonates a s long a s 10 y ears, without a significant increase in risk associated with bisphosphonate use. 3

This data prompted the Food and Drug Administration (FDA) to state that they were going to undertake a thorough review of possible association between bisphosphonate use and thigh bone fractures. Specifically, the FDA worked with outside experts, including members of the recently convened American Society for Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force to gather additional information that might provide more insight into this issue. It is important to note that the FDA did review the data concerning the link between oral bisphosphonates and thigh bone fractures in 2008 and concluded t hat t here w as no clear association be tween bisphosphonate use and these fractures.

The ASBMR Subtrochanteric Femoral Fracture Task Force report has now been published in the Journal of Bone and Mineral Research (JBMR). As mentioned in the task force report, atypical fractures are very rare, but one should be aware of warning signs and symptoms in someone on long t erm bi sphosphonate t herapy ( new groin or thigh pa in): “ we know t hat bi sphosphonates prevent many, many common fractures. F or t his r eason, w e w ant t o e mphasize t hat pa tients should not stop taking these drugs because they are afraid of the much more uncommon femur fractures. They should talk to their health professionals about their concerns and should let them know if they experience any new groin or thigh pain.”4 The exact cause for these unusual atypical fractures is still uncertain and more research is needed to identify who is at risk and why these fractures occur.

Other studies, evidence and data support the notion that thigh fractures associated with bisphosphonate use are extremely rare with less than 1% of femur fractures being atypical. The risk of other osteoporotic fractures is significantly reduced with bisphosphonate therapy and the benefits far exceed the risks. Nonetheless, if groin or thigh pain is present, this should be further evaluated with bone scans or MRI and if necessary a change in therapy may be required.

References: 1. http://www6.aaos.org/news/pemr/releases/release.cfm?releasenum=877

2. Abrahamsen B, Eiken P, Eastell R. Subtrochanteric and diaphyseal femur fractures in patients treated with alendronate: a register-based national cohort study. J Bone Miner Res. 2009;24:1095-102.

3. Black DM et al N Engl J Med 2010; 362: 1761-71

4. http://www.asbmr.org/About/PressReleases/Detail.aspx?cid=a68f2b70-a117-4094-9f6fb5993c6a6149

Sun Life Financial donates more than $100,000 to the Fracture Navigator Program, Dartmouth, N.S.

Written on May 14, 2012. Posted in Latest News.

On May 25, 2012 Sun Life Financial announced a donation of $ 103,232 to the Fracture Navigator Program, led by Dr. Diane Theriault at the Dartmouth General Hospital in Nova Scotia. For patients with osteoporosis in the community, this program will help reduce future medical complications, including repeat fractures, through early diagnosis and appropriate treatment.

“One of the priority areas for Sun Life’s philanthropy program is health-related initiatives, especially those that promote wellness or prevention,” said Scott Woodman, Regional Vice-President, Atlantic Region, Sun Life Financial Canada. “We’re proud to partner with the hospital to be part of the Fracture Navigator Program, which can make a real difference for many people in our community.”

From left to right: Scott Woodman, Regional Vice-President, Atlantic Region, Sun Life Financial Canada; Michael Wild, Advisor, Sun Life Financial Canada; Kim Conrad, Chair, Dartmouth General Hospital Charitable Foundation; Dr. Diane Thériault, Medical Director, Dartmouth General Hospital Fracture Navigator Program.

A whitepaper titled Towards a Fracture-Free Future; published by Osteoporosis Canada in March 2011 highlights the need for effective screening and post fracture care strategies for the identification and treatment of high risk fracture patients. In simple terms, once an individual has broken a bone due to osteoporosis, they are much more likely to break again – making them high risk. While our current medical system is geared to provide effective care for such fracture patients; over 80% of these patients are never offered assessment and/ or treatment of their underlying osteoporosis. They just fall through the cracks in the current health care system and remain at risk for recurrent, debilitating and life threatening osteoporotic fractures. The Fracture Navigator program bridges that very gap in the health care system for the residents of Dartmouth, N.S.

Osteoporosis Canada applauds the efforts of Sun Life Financial Canada in helping close the care gap. With their generous support, the Fracture Navigator program will help to effectively identify and manage these patients- so that their first fracture will be their last.

THE REPORTED ASSOCIATION BETWEEN USE OF ZOLEDRONIC ACID (ACLASTA) AND RENAL IMPAIRMENT

Written on July 14, 2009. Posted in General Public, Position Statements.

We are aware of a recent Food and Drug Administration (FDA) publication that reports on the association between use of zoledronic acid (Aclasta) and renal impairment. 1

We recognize that you might find this report concerning and it may raise questions about your care. Osteoporosis Canada takes your concerns seriously and we will continue to be vigilant in order to inform you about the latest research. The publication has been reviewed by experts from the Scientific Advisory Committee at Osteoporosis Canada and their response is below.

From April 2007 until February 17, 2009 the FDA’s Adverse Event Reporting System received reports of 24 cases of renal impairment and some cases of renal failure associated with the use of zoledronic acid. Over half of the patients had underlying medical conditions such as diabetes, heart failure or chronic kidney disease that might have contributed to the renal failure; or were taking medication that could be damaging to the kidney. Fifty four percent of patients who developed renal disease had increases in serum creatinine after administration of zoledronic acid. Most patients improved after intravenous fluid administration or other supportive care.

It is important to note that all of the FDA reports occurred in patients at risk of developing renal dysfunction– those with underlying moderate to severe renal impairment or other risk factors including use of nephrotoxic medications, diuretic therapy, or severe dehydration. Physicians are encouraged to avoid the use of zoledronic acid in patients with severe renal impairment (creatinine clearance of <35 mL/min); monitor serum creatinine before each dose of zoledronic acid; consider interim monitoring of serum creatinine in at risk patients; assure that patients are adequately hydrated prior to administration of zoledronic acid; and to infuse zoledronic acid over a period of at least 15 minutes.

It is a fact – all medications have risks associated with them. Osteoporosis medications are no exception. Every time a physician recommends and prescribes a medication, it includes carefully weighing the risks and benefits of taking a medication. While the reports on the association between zoledronic acid and renal failure are concerning this happens very rarely.

Fractures (broken bones) due to osteoporosis, on the other hand, are extremely common. Osteoporotic fractures are linked to additional fractures, altered quality of life, worsening of other health conditions and in some cases – death. Bisphosphonate medications, such as zoledronic acid provide protection from osteoporotic fractures. Your healthcare team is available to review any concerns or questions you may have about this issue.

1. http://www.fda.gov/downloads/Drugs/DrugSafety/DrugSafetyNewsletter/UCM168579.pdf