Know Your Bones. Know Your Bones Launches Nationally Treatment Adherence and Fracture Risk Reduction News Update

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1 Know Your Bones Know Your Bones Launches Nationally Treatment Adherence and Fracture Risk Reduction News Update Medical issue special edition 2016

2 2 Know Your Bones Launches Nationally Osteoporosis Australia and the Garvan Institute of Medical Research have launched Know Your Bones, a major consumer project that aims to increase awareness of osteoporosis and bone health in the community. The new risk assessment website, launched mid-june, delivers a freely accessible, online bone health self-assessment tool for consumers. The Know Your Bones website (knowyourbones. org.au) incorporates the Garvan Institute s fracture risk assessment algorithm, which was developed from the internationally recognised Dubbo Osteoporosis Epidemiology Study (DOES Study). The self-assessment provides an estimate of future fracture risk for users over 50 years of age and general risk information for users of all ages. A simple report is generated that summarises any risk outcomes. People with multiple risk factors or with moderate to high fracture risk are advised to speak with their doctor. Osteoporosis Australia CEO Greg Lyubomirsky said, General practitioners are ideally placed to investigate osteoporosis or fractures early. This tool is intended to assist busy GPs in making decisions with regard to patient management. It helps patients understand their risk profile and prompts them to seek advice from their doctor. Greg Lyubomirsky said, Ultimately we want to stop first fractures and reduce repeat fractures that has very obvious benefits for patient well-being and cost savings for the healthcare system. Professor John Eisman AO from the Garvan Institute of Medical Research said We are very proud at Garvan to know the findings from our osteoporosis study that Welcome Osteoporosis and its management remain issues of great concern. While being a preventable and treatable condition, the majority of people with osteoporosis go undiagnosed and untreated. One of the reasons for this notorious care gap is a conspicuous lack of bone health awareness amongst the public. This special edition of Osteoblast introduces a new, freely accessible online tool Know Your Bones which aims to help people self-assess their bone health and individual risk of osteoporotic fracture. Know Your Bones was developed based on the data from the Dubbo Osteoporosis Epidemiology Study and allows users to calculate an estimate of future fracture risk for those over 50 years of age. I encourage you to point your patients to this new resource and discuss the results as they become available. Those who are lucky enough to have been placed on effective treatment often discontinue therapy due to a perceived fear of adverse outcomes, usually fueled by exaggerated and often misleading media reports. John Eisman s article in the current issue provides a summary of the facts that should help you put things into perspective and keep your patients on treatment. Prof Markus Seibel

3 3 Know Your Bones Launches Nationally (Cont.)...It s also a time saver for GPs because it raises the issue with their patients in advance of the consultation. has been running for over 25 years is contributing this assessment tool for the wider community and ultimately could improve awareness about fracture risk. Professor Peter Ebeling AO, Medical Director of Osteoporosis Australia, said, In 2016 in Australia we estimate there will be 155,000 fragility fractures due to poor bone health, and that 66% of Australians over the age of 50 years have osteoporosis or osteopenia, placing them at increased risk of such a fracture. Despite these alarming statistics, bone health is not a high priority for the community or for health professionals, so this is something we intend to change. The Know Your Bones website asks a series of questions in four sections personal details (including age, any previous fractures and bone mineral density if known), medical history (diagnosed conditions that impact bones), lifestyle habits (including smoking, drinking, calcium intake, sun exposure and exercise) and medications (use of osteoporosis medication or supplements). The assessment will only take around 5 minutes for consumers to complete. Professor Peter Ebeling said, We know consumers like credible health information and this web-based self-assessment of their own risk of fragility fractures will provide consumers with an easy summary they can take to their GP. It s also a time saver for GPs because it raises the issue with their patients in advance of the consultation. Professor Peter Croucher, Head of the Bone Biology Division at the Garvan Institute, said, This is a unique opportunity to translate research into a practical solution and improve bone health. In particular, Know Your Bones should help identify people who may have osteoporosis and ensure they are treated effectively. The DOES study, which forms the basis of the fracture risk algorithm utilised within the Know Your Bones website, has been unusually valuable for understanding of osteoporosis because it has been running for over 25 years and has captured information about both men and women. This has allowed significant patient follow-up, enabling Garvan Institute researchers to uncover the common risk factors for fracture and to understand what happens following a fracture. Key findings from the study have included insights into osteoporosis in men, fracture risks, risk of subsequent fracture following a first fracture, and mortality following fracture. The study is also playing a critical role in identifying some of the key genetic factors that control our skeleton and lead to bone diseases. This is the first project to be launched under the Bone Alliance between Garvan Institute of Medical Research and Osteoporosis Australia. Osteoporosis Australia Chairman John Hewson said, Our alliance with the Garvan Institute demonstrates that like-minded organisations with a common vision can join forces and share expertise and evidence-based research to ultimately benefit the community. Know Your Bones awareness and education program for general practice is proudly supported by Amgen, I-MED Radiology Network and Allergan.

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5 5 Treatment Adherence and Fracture Risk Reduction John A Eisman AO FAHMS MB BS PhD FRACP St Vincent s Hospital, Garvan Institute of Medical Research, University of Notre Dame Australia, UNSW One of the major challenges in treating any medical condition is patient adherence to therapy. This is a particular problem for osteoporosis where there is clear evidence that poor adherence is associated with marked loss of anti-fracture efficacy. 1 In that study, based on actual prescription evidence, individuals who continued with treatment for 2 to 3 years had ~45% reduction in fracture risk. However in those who adhered to treatment for only 1 to 2 years there was less efficacy (~30%) and in those who adhered <1 year there was virtually no fracture risk reduction. It is in this context there are a number of challenges in osteoporosis management. Probably the first challenge in Australia is that only a small proportion of women and an even smaller proportion of men who have suffered fragility (i.e. osteoporotic) fractures get any effective treatment to reduce the risk of subsequent fractures; only about 25% of women and <10% of men. 2 When one superimposes on this situation poor long-term adherence, i.e. less than 50% at one year, 3 the challenge becomes obvious. With media driven concerns about potential risks of treatment and misleading concepts of drug holidays, the problem becomes even more serious. Drug holidays as a concept came from one of the initial alendronate studies in women with relatively good bone density treated for 5 years with alendronate and then randomised to either continue or stop the drug. An overall analysis of this data stated there was no change in fracture rates despite a statistically significant increase in clinical vertebral fracture. 4 In a subsequent analysis of the same data, 5 it was clear that fracture risk went up in women whose bone density was lower than -2.5 T-score. In a zoledronic acid study, individuals treated for 3 years showed a clear reduction in fracture rate and individuals were then randomised to continue treatment or placebo. In those on placebo the vertebral deformity rate increased back towards that observed in the initial placebo group. 6 With denosumab, the effect of treatment on bone density and bone turnover wears off over 6-12 months. 7 While there are no data that this is associated with increased fracture rate, it seems likely that this would be the case. Thus on these data there is no rational basis for a drug holiday in individuals who are at high risk of subsequent fractures particularly those with bone density T scores below Potential risks of treatment are real but have to be seen in the context of actual risk. For both osteonecrosis of the jaw and freight typical femur fractures, the actual risk is probably less than one in 10,000 to 1 in 100,000 patient years of treatment. In individuals at risk of fracture is clear that these risks should not interfere with treatment. It is worth noting that atypical femur fractures and perhaps osteonecrosis of the jaw may be slightly more common in individuals of Asian background. Osteonecrosis of the jaw has been seen more commonly in individuals being treated for metastatic cancer in bone. In this situation the dose of anti-resorptive agents, bisphosphonate or denosumab, is usually 10 to 20 times that used in osteoporosis treatment and, in these individuals, there are other parameters related to ill health including corticosteroid use. Perhaps more importantly, it is now clear that even if osteonecrosis of the jaw is observed in osteoporosis treatment, conservative management including antibiotics, local protective actions including gum closure will usually result in healing in the medium term A typical femur fractures are another known complication of anti-resorptive treatments but again relatively uncommon. Data suggest that for one atypical femur fracture 100 femoral neck fractures would have been prevented. 11,12 Clearly the balance of benefit outweighs the risk. On the other hand, individuals who report made mid-thigh pain should have radiological investigations and if there is evidence of lateral cortical stress fracture, anti-resorptive therapy should be ceased and the individual referred for surgical assessment. Bring this situation together, relatively few women and even fewer men are treated with effective osteoporosis therapy and many of these are not encouraged to maintain good levels of adherence because of exaggerated concerns about potential side effects. This is a serious challenge in the clinical situation, where there is clear evidence of overall benefit for a continuation of effective therapy in those at high risk. The call to action is to treat fragility fracture seriously by initiating therapy as appropriate and encouraging long-term adherence with reassurance about the overall risk-benefit ratio. References available upon request.

6 6 NEWS UPDATE Reaching Regional Australia Osteoporosis Australia have a partnership with with MeasureUp mobile bone density testing service to reach patients in regional Australia. In the past year the service worked with local doctors in different states and scanned thousands of patients in regional areas. Greg Lyubomirsky, CEO Osteoporosis Australia said, This important partnership has helped at-risk patients receive a bone density test and has shown participating doctors that 25% of patients are found to have osteoporosis and 50% have osteopenia. Greg Lyubomirsky said we want to prevent both first fractures and repeat fractures so we need to identify patients with underlying poor bone health and then take action to protect their bones. There are rebates for bone density tests for a broad range of risk factors. MeasureUp provides mobile DXA services to regional doctors and their patients to help bridge the current gap in diagnosis of osteoporosis. International Conference Gathers Experts Professor Peter Ebeling, Medical Director of Osteoporosis Australia presented at the recent World Congress on Osteoporosis, Osteoarthritis & Musculoskeletal Diseases (WCO-IOF-ESCEO) in Malaga, Spain April The annual conference is the world s largest annual forum for the presentation of clinical research and new advances in the prevention and management of bone, muscle and joint disorders with delegates from over 60 countries attending. This year over 1150 abstracts were submitted and over 3,500 delegates attended. Free online Active Learning Module (ALM) for GPs It s nearly the end of the current triennium. Do you need additional CPD points? Our online ALM, hosted by ThinkGP is free and flexible. The ALM provides the details you need to effectively treat and manage osteoporosis and fracture risk as well as provide key bone-health information to at-risk patients. Accreditation includes 40 CPD points with RACGP or 30 CPD points with ACRRM. Register today at Fact Sheets for Patients Osteoporosis Australia has a series of consumer fact sheets available for patients on the website covering key topics (calcium, vitamin D, medication) and key medical conditions that can impact bones. Doctors can simply direct patients to Osteoporosis helpline for your patients Freecall Post-diagnosis support General information MEDICAL ISSUE special edition 2016 Medical Editor: Prof Markus Seibel Editorial: Melita Daru Jessica Wilkinson Advertising: Melita Daru Osteoblast is a publication of: Osteoporosis Australia ABN PO Box 550 Broadway NSW 2007 National office National hotline Copyright Osteoporosis Australia Except as provided by the Copyright Act 1968, no part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means without the prior written permission of the publisher. Resources for General Practice Information and resources for general practice can be accessed online in the GP section of the Osteoporosis Australia website, located under the Healthcare Professional section.