Taking Bone Health Seriously

Taking Bone Health Seriously Medical issue Autumn 2014 New Report reveals Australia s Poor Bone Health Research Bites: Research Review by Dr Lisa Croucher Patient Case Study: Doctors Comment on Patient Management Osteoporosis in Men New ALM for GPs Healthy Bones Australia Serious about Prevention

2 New Report Reveals Australia s Poor Bone Health Osteoporosis Australia has launched a new burden of disease study titled Osteoporosis Costing All Australians A new Burden of Disease Analysis 2012-2022. The new study, co-authored by Jennifer Watts and Julie Abimanyi-Ochom from Deakin University and Kerrie Sanders from the University of Melbourne, was launched at an Osteoporosis Australia event at Parliament House Canberra on the 4th December. The report is a detailed analysis of the burden of osteoporosis in the Australian population in 2012 and estimates the annual impact of the disease over the next decade (2013-2022). Both the prevalence rates and associated costs are alarming. Osteoporosis Australia Chairman John Hewson said it s time the nation took bone health seriously. We are calling on health care professionals to make bone health a higher priority. Action today can reduce the impact of this disease, both in the short-term and for the future of bone health in Australia. Key findings of the report The report outlines prevalence of poor bone health in Australia, the numbers of related fractures and associated costs, key findings include: Australians over 50 who currently have osteoporosis and osteopenia 66% 4.74 million Australians over 50 66% of adults aged 50 years and over are affected by osteoporosis and osteopenia, accounting for 4.74 million Australians. In 2012 there were 140,822 fractures due to poor bone health and this is set to increase to 183,105 by 2022, a rise of 30%. Total direct and indirect costs of osteoporosis, osteopenia and related fractures is estimated at $33.6 billion over 10 years (2012$). Costs include ambulance services, hospitalisations, emergency department and outpatient services, rehabilitation, aged care and community services. Fractures impacting Australia Professor Peter Ebeling, Medical Director of Osteoporosis Australia, said previous studies have underestimated the burden of osteoporosis and the reality is fractures are costly to repair. Total costs of osteoporosis in 2012 were $2.75 billion, and fracture costs alone accounted for $1.617 billion. It is estimated that in 2022, the total costs will be $3.84 billion (2012$) for that year. As the annual number of fractures is currently high, it is estimated there will be 1.6 million fractures over a 10 year period, this includes new fractures and re-fractures. Hip fractures remain the most costly type of fracture. The mean direct cost per hip fracture is $23,000 in patients over 50 and is higher in those over 70. Welcome It s time the nation took bone health seriously. We are calling on health care professionals to make bone health a higher priority. These are the words of Osteoporosis Australia Chairman, John Hewson, introducing the new Burden of Disease Analysis for osteoporosis in Australia at Parliament House in December of last year. The study outlines that poor bone health is wide-spread amongst older Australians (and that means men as well as women). Thus, a staggering 66% of adults over 50 are affected by low bone mass that s over 4.7 million people in Australia. During the time you need to read this column, at least one osteoporotic fracture has occurred in Australia (maybe even to one of your patients), adding up to a whopping 140,822 fractures per year. And that s the data from 2012 in 2022, this number will have increased by 30% to 183,105 fractures per year, or one break every 2.9 minutes. While I am sure you are all too familiar with the burden that a fracture causes to patients and their relatives, I am keen to highlight the cost to the tax payer. Adding both direct and indirect costs of osteoporotic fractures, we spend more than $3billion per year on this preventable disease. We must all act and bring these numbers down. Prof Markus Seibel

3 Australia s Poor Bone Health New Report (Cont.) The total cost of fractures over the next 10 years is expected to be $22.7 billion. Hospital costs account for 73% of total direct costs, representing the largest proportion of direct fracture costs. Osteoporosis and osteopenia are not just a women s disease. Men account for up to 30% of all fractures related to osteoporosis and osteopenia. Reducing the burden of fractures requires attention to those with osteopenia as well. Over half of the fragility fractures in the population arise from people with osteopenia. Calling for action to prevent fractures Osteoporosis can be diagnosed and managed to reduce fracture rates, and in many cases fractures can be prevented. However osteoporosis remains under-diagnosed, even when a fracture has occurred. Professor Ebeling says fracture patients often fall through the gaps in Australia, the health care system is dealing with the fracture without addressing the underlying cause of that fracture. The good news is we can improve on this. We urgently need to support re-fracture prevention and community education to break the cycle of poor bone health and fractures says Professor Ebeling. Australians who fracture need to be supported and need co-ordinated care so they don t re-fracture. Fractures are more costly than targeted interventions. Launching the report The report was launched at Parliament House in Canberra and attended by ministerial advisors to the Prime Minister Tony Abbott and to The Hon Fiona Nash Assistant Minister for Health. The Hon Catherine King Shadow Minister for Health and The Hon Shayne Neumann Shadow Minister for Ageing also attended, along with other politicians. Osteoporosis Australia was delighted to welcome representatives from national organisations including, The Australian Medical Association (AMA), Australian & New Zealand Bone & Mineral Society (ANZBMS),The Pharmacy Guild of Australia, The Pharmaceutical Society, Carers Australia, Australian Institute of Health and Welfare (AIHW) and the Commonwealth Department of Health. John Hewson and Professor Peter Ebeling at the report launch We know these interventions, complemented by adequate calcium, vitamin D and exercise can help our patients, we just need to be pro-active. The way forward In 2013 there was 1 fracture every 3.6 minutes in Australia. This equates to 2,765 fractures per week. By 2022 there will be 1 fracture every 2.9 minutes. This compares to a fracture every 8.1 minutes in 2001 and a fracture every 5-6 minutes in 2007. Preventing, investigating and treating poor bone health must be a priority for all health professionals. As Australia s population continues to age and hospital services are already placed under pressure, a focus on keeping patients out of hospital or preventing patients from returning to hospital is a priority. Professor Peter Ebeling encourages doctors to utilise the broad availability of bone density testing outlets and the range of treatments currently available in Australia when approaching poor bone health in patients. We know these interventions, complemented by adequate calcium, vitamin D and exercise can help our patients, we just need to be pro-active. A copy of the report can viewed or downloaded from the Osteoporosis Australia website www.osteoporosis.org.au

4 researchbites Research Review by Dr Lisa Croucher (Osteoporosis Australia Scientific Advisor) Major new report on the impact of osteoporosis in the Asia-Pacific region The International Osteoporosis Foundation (IOF) has released a new report, the Asia-Pacific Regional Audit 2013. Incorporating new and updated information about the current status of bone health throughout the Asia-Pacific, the report reveals that the recent impressive gains in health and longevity in the region now threaten to be undermined by an enormous rise in osteoporosis and a looming epidemic of fragility fractures. Key findings include: By 2050, over half of all hip fractures in the world will occur in Asia Osteoporosis is greatly under-diagnosed and under-treated Services to prevent secondary fractures are very uncommon in the Asia-Pacific region Rural areas have poor access to diagnostics and treatment Lack of awareness is one of the biggest barriers to osteoporosis care Australia fares relatively well in some aspects of osteoporosis diagnosis and treatment, compared to its Asia-Pacific neighbours. However, the disease remains significantly underdiagnosed and under-treated in this country. Although a national health priority, neither State nor Commonwealth Governments have been successfully engaged to tackle the problem. The IOF recommends several cost-effective and evidence-based solutions essential pillars to all effective long-term strategies to improve bone health in the Asia-Pacific region. These include improving training for health professionals, establishing secondary fracture prevention initiatives, widening access to diagnosis and treatment, establishing national prevention programs and investing in research. The Asia Pacific Regional Audit 2013 serves as the IOF s call to action for this neglected disease, in a region of the world set to become most vulnerable to its devastating impacts. Find the full report on the Osteoporosis Australia website, or the International Osteoporosis Foundation website. Coffee not a villain after all? High coffee consumption is often cited as a risk factor for osteoporosis, but the evidence is far from conclusive. A comprehensive study published recently by a Swedish research group (Hallstrom et al., Am J Epidemiol, 2013;178:898-909) has shown that high coffee consumption may not increase the risk of fracture. The study focused on a cohort of 61,433 women born between 1914 and 1948, following them up in the years 1987-2008. Bone density was measured in a sub-cohort of 5022 women. High coffee intake (at least 4 cups daily) was associated with a small (2-4%) reduction in bone density in the sub-cohort, compared to those consuming less than one cup daily. Although the risk of osteoporosis was found to be slightly greater in those with a high coffee intake, there was no evidence that this translated into an increased risk of fracture at any site. Excessive caffeine, present also in tea and cola drinks, is known to inhibit calcium absorption. This study presents some interesting findings, but more research is needed to establish the risks of high total caffeine consumption, relative to the wellestablished risks to bone health of other lifestyle factors, such as excessive alcohol intake and smoking. Sclerostin inhibition a new approach to osteoporosis treatment There is a great need for new safe and cost-effective drugs that actively produce new bone and restore bone architecture in people with severe osteoporosis. A study published recently in the New England Journal of Medicine (McClung et al., 2014. DOI: 10.1056/ NEJMoa1305224) introduces a potential new avenue for treatment - romosozumab, a monoclonal antibody directed against the bone protein sclerostin. Sclerostin inhibits the proliferation and activity of bone-forming osteoblasts; blocking the activity of sclerostin with romosozumab enhances bone-building processes. A phase 2 trial in healthy post-menopausal women with osteopaenia demonstrated significantly increased bone mineral density at nearly all sites with romosozumab, over and above levels achieved with the bisphosphonate alendronate and the established bonebuilding agent teriparatide (Forteo), which is expensive, difficult to administer and highly restricted in Australia. These early results are impressive, but more research is needed to answer a number of important questions. The trial was unable to determine whether the improvements in bone density translate into decreased fracture risk, and questions over optimal treatment duration and long term safety have yet to be answered. A phase 3 trial in post-menopausal women with osteoporosis, now underway, will address some of these issues, and may bring us a step closer to an anabolic agent for osteoporosis that is safe and effective as well as accessible.

5 patient case study In this section doctors review a real life patient case study and comment on how they would manage the scenario Patient A, Age 61 Patient A, male, was vacuuming at home when he tripped on the cord and fell. He was admitted to hospital with a fractured shoulder and stayed 2 nights before being discharged in a sling. Several weeks later while attending the fracture clinic (to check about the sling being removed) he was approached and encouraged to take a Bone Density Test. Patient A had a BMD scan and it was found he has osteoporosis in the spine and hip. Initially he had no apparent risk factors and had never smoked and is active, (he likes walking, pilates and weights). In his 20s he was told he had too much calcium in the body (after blood tests) so he had assumed he had strong bones and did not eat many high calcium foods. He also had calcification around the heart. He does have a family history of osteoporosis, his mother has been diagnosed. GP comment on patient (Dr Peter Piazza, NSW) Patient A s case raises a number of questions: What was the diagnosis for too much calcium in his twenties? Did his self-imposed calcium restriction stop him achieving adequate peak bone mass? Is the calcification around the heart in his coronary arteries, and will calcium supplementation be contraindicated in his treatment? What is his serum calcium (Vitamin D & PTH) now? What is his other hormonal status (thyroid, androgen & adrenal)? Patient A is at high risk for future fracture, based on his recent fragility fracture, BMD in the osteoporotic range and the family history of osteoporosis in his mother (has she had any fractures?). Once the questions posed above have been resolved, he would need to be treated with an antiresorptive. Because of the possibility of coronary artery disease, strontium ranelate might best be avoided. The choice among the other agents would be guided as much by Patient A s preference, having regard to which of the agents and their forms (oral or injectable) that he would be most compliant with. Endocrinologist comment on patient (Dr Kirtan Ganda, NSW) This 61-year-old male has sustained a symptomatic non-vertebral minimal trauma fracture in the context of osteoporosis on DXA, a family history of osteoporosis and a low calcium intake. Thus, he is at significantly heightened risk of further osteoporotic fracture. History and examination is required to look for secondary causes of osteoporosis and osteoporosis risk factors such as coeliac disease, hypogonadism, prednisone use, inflammatory arthritis, anti-epileptic use and history of other falls. Relevant investigations including renal function, calcium, phosphate, thyroid function, 25-OH-vitamin D level. The presence of prevalent fractures needs to be documented with a thoracolumbar spine x-ray. He would certainly benefit from pharmacotherapy, in the form of oral or intravenous bisphosphonate or denosumab therapy, tailored to his co-morbidities and preferences. Non-pharmacological therapy would include education regarding falls reduction, increasing dietary calcium intake to 3 serves of dairy per day and ensuring a 25-OH-vitamin D level above 75nmol/L. Rheumatologist comment on patient (Dr Graeme Jones, TAS) This case is not straightforward. The patient is young for male osteoporosis, has no apparent risk factors and has a history suggestive of hypercalcaemia. It should be noted that hypercalcaemia does not infer strong bone (in most cases, it is the opposite). Many cases of male osteoporosis are said to be secondary but my experience is that investigation rarely identifies a cause. I would generally look at renal and liver function, serum 25 hydroxy D3, testosterone and coeliac antibodies. In this case, I would also strongly suggest calcium, phosphate and parathyroid hormone. In most cases, I would also use a parenteral antiresorptive at least initially. I would tend to aim for a vitamin D level between 50 and 75nmol/l and a calcium intake of 600-800mg/day in all cases. In those with a t-score less than -3, I would offer parathyroid hormone for 12 months (recognising that this isn t subsidised by PBS) followed by a parenteral antiresorptive. Final story: These events have only recently occurred and Patient A is waiting to attend follow up appointments with specialists regarding treatment options and to further clarify the state of his bone health.

6 Osteoporosis in Men Professor Peter Ebeling MBBS MD FRACP Medical Director, Osteoporosis Australia Osteoporosis in men contributes to significant morbidity and mortality, yet is under-recognised and undertreated by family physicians, despite one-third of all hip fractures worldwide occurring in men. Hip fractures in men are associated with greater mortality (up to 37.5% in the first year) compared with their mortality in women. Timely diagnosis and treatment of osteoporosis in men are therefore critical. Secondary causes for osteoporosis are more common and need to be excluded. The most common are tobacco use, alcohol excess, glucocorticoids and hypogonadism. Genetic causes are also important. Less common secondary causes include HIV and its treatment, chronic opiod use (causing secondary hypogonadism), malabsorption (including coeliac disease) and myeloma. Men with a prior fragility fracture, or who have an osteoporotic T score ( -2.5) should be strongly considered for anti-osteoporotic therapy. The selection of anti-osteoporotic therapy depends on evidence of efficacy and patient choice. In general, studies of osteoporosis therapies in men have been smaller than those in postmenopausal women. For example, most studies of oral or intravenous (i.v.) bisphosphonate therapy in hypogonadal or eugonadal men with osteoporosis have reported effects on bone mineral density (BMD) and biochemical bone turnover markers, rather than on reductions in fragility fractures. An exception has been in the use of intravenous zoledronic acid infusions given to elderly men and women after a hip fracture, which resulted in reductions of clinical, clinical vertebral and nonvertebral fractures, and also in mortality, by 28% compared with placebo infusions. Studies in men with osteoporosis have reported reductions in vertebral fractures and similar increases in BMD with either oral bisphosphonates or i.v. zoledronic acid. However, all studies in men have been underpowered to detect reductions in hip fractures. Teriparatide or human PTH (1-34) treatment is a second-line treatment for osteoporosis in men. It has also been shown to reduce vertebral fractures in men. Recently, six-monthly subcutaneous injections of a human monoclonal antibody to RANK Ligand, denosumab, have been approved for the treatment of osteoporosis in men in Australia. Denosumab increases BMD and reduces bone turnover markers in men to a similar degree as seen in studies of postmenopausal women. Strontium ranelate has also been studied in men with osteoporosis and increases BMD in men to a similar amount as seen in postmenopausal women. However, strontium ranelate should be avoided in men with pre-existing cardiovascular disease. In conclusion, oral or i.v. bisphosphonates have a role as monotherapy, as consolidative therapy after a course of teriparatide therapy, or in combination with testosterone replacement in men with hypogonadism and osteoporosis. Bisphosphonate therapy is validated and important in the treatment of osteoporosis in men. Newer alternative firstline treatments are denosumab and strontium ranelate, while teriparatide is a second-line treatment. As evidencebased anti-osteoporosis treatment is readily available, family physicians and patients should recognise that osteoporosis may affect men, so that early diagnosis and treatment can be initiated. Family physicians should be at the forefront of managing osteoporosis in men as well as in women, as they are already for many of the other chronic diseases associated with ageing.

7 New RACGP-accredited ALM for GPs Osteoporosis Australia, in partnership with ThinkGP, has launched an online active learning module (ALM) for GPs titled Osteoporosis Early detection, fracture prevention and treatment in primary practice. The ALM is free to access and designed to allow modules to be completed at your convenience. The ALM covers topics including identification of at-risk patients, pharmacologic management, the role of calcium, vitamin D and exercise, and falls prevention. Expert videos and interactive case studies enhance the educational experience. Modules also contain links to relevant guidelines and other educational material. Simply register and log-in for the ALM at: www.thinkgp.com.au THe cities Dates Sydney February 22 Melbourne March 22 Adelaide May 17 Brisbane June 21 Perth August 16 & Children s Women s HealTH updates 2O14 ^ Protos new Product Information (Australia) for strontium ranelate Osteoporosis Australia is aware of research findings that indicate an increased risk of cardiovascular events with strontium ranelate (Protos). The European Medicines Agency recently recommended further restricting strontium ranelate to patients who cannot be treated with other medicines approved for osteoporosis. Australia s Therapeutic Goods Administration (TGA) has completed its own review of the available data and issued a Safety Advisory (3 April 2014). The Australian Product Information for Protos has now been updated with a black box warning. This states that Protos should only be used when other medications for the treatment for osteoporosis are unsuitable, and must not be used in patients with past or current ischaemic heart disease, peripheral vascular disease, cerebrovascular disease, uncontrolled hypertension, venous thromboembolism or pulmonary embolism. Caution is advised for patients with risk factors for cardiovascular events or venous thrombosis. Patients should be informed of the risks of using Protos, and those prescribed the drug should be monitored every 6 months. The TGA statement, with a link to the updated Product Information, can be found here:www.tga.gov.au/ safety/alerts-medicine-strontium-ranelate-140403.htm#.uzzoo1czc7c Osteoporosis Australia s Medical and Scientific Committee will continue to monitor research and recommendations regarding the use of Protos in Australia, and will provide up-to-date information to both health professionals and consumers that helps to clarify the situation as it arises. Patients who are currently taking Protos and are concerned about these developments should speak to their doctor about their treatment. 2o14 cities General Practice education days Dates Sydney August 23 Melbourne September 13 Brisbane October 18 Perth October 25 Adelaide November 1 www.healthed.com.au W www.healthed.com.au P 1300 797 794 F 1300 797 792 M PO Box 500 Burwood NSW 1805 e info@healthed.com.au

8 It s time to get serious about prevention In many cases osteoporosis is preventable, so we need to start focusing on positive bone health messaging. Leading this communication is Healthy Bones Australia, developed by Osteoporosis Australia. The Healthy Bones Australia website and online calculator were specifically designed for consumers to keep track of their bone health, taking into account individual variables such as age, gender and location within Australia. The Healthy Bones Australia calculator assists adults in understanding if they are getting enough calcium PLUS weight bearing exercise PLUS sunshine on a regular basis. The calcutaor also includes built in hints and tips and detailed information about the what, why and how of bone health, to assist your patients in taking some positive steps to avoiding osteopenia and osteoporosis. Let s use a hypothetical case study Annie is an active 35 year old who lives in Botany NSW and prides herself on her ability to lead a healthy lifestyle. She is weight conscious and swims every second morning, as a busy executive Annie spends longs days at the office. Does she sound familiar? Is she taking care of her bone health? Does she even recognise that she needs to? Here is a snapshot of Annie s day using the Healthy Bones Australia Calculator: Annie starts the day out with a tub of low fat yogurt and a banana, the remainder of her food choices for the day do little to meet her RDI for calcium. Two cups of black coffee, sushi for lunch, grilled chicken, half an avocado and salad for dinner, and a large apple to keep her going through the afternoon don t help her Healthy Bones Score of 3 which falls short of her standard adult target. Whilst an hour swimming at the local aquatic centre is great for her cardio health, it does nothing to assist her bone health. Annie needs to start thinking about ways in which she can incorporate weight bearing exercise into her routine. A ten minute skip before swimming and she would achieve her target Healthy Bones Score of 5 for exercise. As Annie is in the office all day, her brief walk between the carpark and the aquatic centre doesn t even register for vitamin D. But just a ten minute break midmorning (during summer), having her coffee outside would be all that she needs. Simple to use, the Healthy Bones Australia website and calculator are quick references that both you and your patients can use to help maintain positive bone health attributes. We encourage you to take the time and put it to the test and then let s work together to alert the community. For more information on Healthy Bones Australia visit: www.healthybonesaustralia.org.au MEDICAL ISSUE Autumn 2014 Medical Editor: Prof Markus Seibel Editorial: Melita Daru Sophie Treneman Advertising: Melita Daru Osteoblast is a publication of: Osteoporosis Australia ABN 45 098 570 515 PO Box 550 Broadway NSW 2007 National office 02 9518 8140 National hotline 1800 242 141 www.osteoporosis.org.au Copyright Osteoporosis Australia 2013. 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 Health Professional section. www.osteoporosis.org.au

9 IT S TIME TO PRESCRIBE MORE DAIRY The 2013 NHMRC Australian Dietary Guidelines recognise many health benefits linked to adequate intakes of milk, cheese and yogurt. 1 The new recommendations for serves per day of milk, cheese, yogurt and/or alternatives vary by age and gender, but most Australians are not consuming enough of these foods. 2 To help you educate your patients about how much they need, you can view the new recommendations at Legendairy.com.au/HP EVERY PATIENT NEEDS MILK, CHEESE, YOGURT AND/OR ALTERNATIVES 1. NHMRC (2013) Australian Dietary Guidelines. Canberra, Australia. 2. Doidge JC, Segal L. ANZJPH 2013; doi: 10.1111/1753-6405.12135. Dairy Australia 2014. All rights reserved. Wellmark DAA22407 02/14