Advance reports 41

Advance reports Included in this report are the highlights of the European Congress on Osteoporosis and Osteoarthritis, Bordeaux, France and details of a new blood glucose monitoring system.

Eve Batt GM email [email protected]

Economic burden of fractures €39 billion EUR. The highest to grow as the number of seniors in Europe: a substantial costs were in the EU’s five increases in Europe. Studies have problem largest countries—Germany (9.3 estimated that the number of Researchers at the European billion), Italy (7.2 billion), UK fractures will more than double Congress of Osteoporosis & (5.6 billion), France (5 billion), by 2050 unless preventive action Osteoarthritis (IOF-ECCEO) Spain (2.9 billion). is taken. in Bordeaux have presented The direct costs of treating new data which shows that the new fractures accounted for Strontium ranelate modifies economic burden of fragility €26 billion EUR, long-term progression of osteoarthritis fractures in the 27 member states fracture care €11 billion and Strontium ranelate (Protelos®) of the European Union (EU) far pharmaceutical prevention reduced structural progression exceeds previous estimates, with only €2 billion. Excluding of osteoarthritis (OA) in knee hip fractures accounting for pharmaceutical prevention costs, joints by one third, fnds a study, around 55% of costs. hip, vertebral, wrist and “other presented at the IOF-ECCEO The investigators used a fractures” comprised 55%, 5%, meeting. The study, showing population-based model to 1% and 38% of the economic a reduction in the progressive estimate the economic burden burden respectively. increase in joint space narrowing, of fractures in 2010, using data John A. Kanis, Professor is the frst ever to demonstrate a on fracture incidence, costs Emeritus at the University of disease modifying efect in OA. for pharmaceutical prevention Sheffield, WHO Collaborating Furthermore, the study showed and post-fracture healthcare, Centre, and lead author of the strontium ranelate, currently mortality, and population size to study, said, “We have found licensed for osteoporosis estimate total costs. Data for hip, that pharmaceutical prevention treatment in postmenopausal vertebral, wrist, “other fractures” of fractures only accounts for 2 women, delivered beneficial were included and a societal billion EUR in expenditure— effects on pain, function, and perspective was used as far as approximately 5% of the total mobility. possible. Costs were divided into cost burden of fractures. This Professor Cyrus Cooper cost of fractures occurring within small investment in prevention the lead investigator, from the the index year, cost of prior and treatment reflects the fact Universities of Southampton historic fractures that still are that osteoporosis, which is most and Oxford, said: “After years associated with costs, and cost of often the underlying cause of of labouring to manage patients pharmaceutical prevention. fragility fractures, is neither with blunt tools we fnally have Te total economic burden, being assessed nor treated in the something that allows us to alter including pharmaceutical majority of people at high risk.” the natural history of the disease. prevention, of fractures in the The economic burden of It could reduce or even eliminate EU in 2010 was estimated at fractures in the EU is expected the need for expensive and

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painful joint surgery.” ranelate 2g signifcantly reduced its safety and potential efects on Until now the only treatment the WOMAC score (a global hip, vertebral and non-vertebral for OA, which is estimated to score taking into consideration fractures. afect one in six people in the UK OA pain, function and mobility) The 5-year double blind, (around eight million people), in comparison with placebo randomised, placebo-controlled has been short term symptomatic (p=0.045). No statistically trial included post-menopausal relief with pain killers. signifcant efect was found for women with low BMD at the In the phase III study the 1g dose. lumbar spine or hip (mean age 63 between April 2006 and February “Clearly the 2g dose is needed years). Tey had received weekly 2011 1,683 patients with knee to obtain the beneficial effects odanacatib (at one of four doses osteoarthritis, aged over 50 years on pain and stiffness,” said Dr 3, 10, 25, or 50mg) or placebo for (mean age 62.3 years), were Jean-Yves Reginster, from the two years as well as calcium and randomised to receive strontium University of Liège, Belgium, vitamin D supplementation. At ranelate 2g/day, (n=566), who presented the study in the the beginning of the third year, strontium ranelate 1g/ day scientific session. The 2g dose, they were further randomised a (n=558) or placebo (n=559). he added, is currently used in second time to receive odanacatib Te patients, recruited from osteoporosis. 50mg or placebo for one year. 98 centres in 18 countries, all had Tim Spector, Professor of At the beginning of the fourth a joint space between 2.5mm and Genetics and Epidemiology at St year, the patients who had 5mm. For the primary endpoint, Tomas’ Hospital, London, said: received placebo or the 3mg dose which was measurement of “Many patients with OA also were switched to 50mg for two narrowing of the medial- have osteoporosis, so one of the years whilst the rest continued tibio femoral compartment of exciting aspects (of the study) is on placebo or 50mg. The final the target joint, investigators that we could kill two birds with population included 41 patients utilised the SynaFlexer™, a device one stone to protect both the on placebo and 100 patients on ensuring knees were placed in joints and the bones.” 50mg; 13 women had received the same position throughout odanacatib 50mg continuously the trial for measurement Report by Janet Fricker for fve years. standardisation. In postmenopausal women Results at three years show The benefits of odanacatib on who received odanacatib 50mg that in comparison with placebo BMD and bone markers weekly continuously for five the space between the joints New results of Merck’s years (n=13), there were BMD was 33% wider (less narrow) odanacatib, an investigational increases from baseline of 11.9% for patients receiving the 1g cathepsin K (cat-K) inhibitor for at the lumbar spine, 9.8% at dose (p<0.001) and 23% wider the treatment of osteoporosis in the femoral neck, 10.9% at the (p=0.012) in those receiving the post-menopausal women, were hip trochanter, and 8.5% at the 2g dose. also presented at IOF-ECCEO. total hip. In addition, both doses An extension of a phase 2b trial Additionally, women treated significantly decreased the on postmenopausal women continuously with odanacatib number of participants reaching with low bone mass, found that 50mg maintained a low level of >0.5mm loss of space, a threshold odanacatib continues to increase urine NTx/creatinine (-67.4% known to place patients at a bone mineral density (BMD) over from baseline) through five fivefold increase in the risk of fve years. years of treatment; while levels undergoing joint replacement Odanacatib selectively of serum BSAP remained only surgery over the next fve years. inhibits cathepsin K, the major slightly reduced relative to For the 1g dose, risk was reduced enzyme in osteoclasts that is baseline (-15.3%). In women who by 34% (p=0.049); while for the responsible for the breakdown of were switched from odanacatib 2g dose the risk was reduced by existing bone tissue. Odanacatib to placebo afer the two-year base 44 % (p=0.008). is currently in a large-scale Phase study (n=14), BMD returned to Furthermore, strontium III clinical program to determine near baseline levels.

GM | Midlife and Beyond |April 2012 Advance reports 43

Hertfordshire Cohort Study: iBGStar®, a next generation more in-depth and constructive muscle size and strength can BGM that is discreet, convenient face-to-face conversations with predict bone structure and fts in with today’s patient their patients about personalised New data from the Hertfordshire lifestyles, allows blood glucose blood glucose control.” Cohort Study found that muscle readings to be recorded, stored The DSNs surveyed stated size and strength are related to and shared with healthcare that personalised notes (83%), and bone size and strength according professionals, particularly graphs highlighting averages and to results presented at the IOF- diabetes specialist nurses (DSNs), statistics (53%) would be of use ECCEO congress. while on-the-go. when discussing patients’ BGM There was a strong link iBGStar has been designed results during a consultation. between the age-related to address some of the barriers These are novel features of conditions of sarcopenia and to effective self-monitoring iBGStar and should help patients osteoporosis. The Hertfordshire of blood glucose levels. A and healthcare professionals Cohort comprised 3000 recent survey of 102 UK DSNs to make better diabetes-related men and women born in by Sanofi reveals that nurses decisions together. Hertfordshire UK between believe some of the very iBGStar comes with a free 1931 and 1939. The prospective common barriers to patient self- Diabetes Manager App which is population cohort presented at testing are overly complicated available from the iTunes App ECCEO included a group of 313 devices (61%) and a reluctance store and uploads patient data men and 318 women who were to carry around an obvious from the BGM to the patient’s part of the original cohort. They BGM (47%).1 The easy-to-use iPhone or iPod providing in- were aged 65 years at the time iBGStar is small yet has large, depth diabetes information. Te of the study. easy to read digits and provides iBGStar also comes with a range The study confirmed that personalisation of results, of support services including a individuals with larger muscle including hypo and hyper alerts 24-hour freephone diabetes care sizes are more likely to have and easy mealtime tagging. line, a comprehensive website, better bone structure in terms Te new BGM can also stay patient support materials, a of mineral content, size and attached to the iPhone or iPod lifetime meter replacement strength but not bone density. touch so users can carry around service and free control solution. Te relationship between physical one less device. According For patients who do not performance and bone structure to the DSNs surveyed, this is have an iPhone or iPod touch, remains unclear. something that is key to enhance Sanofi has also launched the Professor Cyrus Cooper, BGMs—with over two thirds BGStar®, which is an easy- Director of MRC Lifecourse (68%) stating that BGMs could to-use blood glucose meter Epidemiology Unit, University be improved by working with the that can help reduce patients’ of Southampton, said: “These electronic equipment patients everyday concerns about their fndings have crucial implications already use, such as a mobile condition. The BGStar features for the clinical definition of phone or MP3 player.1 a large, backlit screen and a sarcopenia and the diferent efects Dr Sarah Jarvis, GP and non-slip surface for confident of muscle size, muscle strength author of Diabetes for Dummies® handling and ease of use. It is and physical performance on (UK Edition), said: “This is also accompanied by Diabetes harder clinical endpoints such as a long-awaited 21st century Management Software that falls and fractures.” alternative to current BGMs that allows data to be quickly fts with the lifestyles of people displayed and managed. Sanofi brings blood glucose living with Type 1 diabetes today. For further information monitoring to the iGeneration It is not only simple to use, but its and support, please visit www. Te frst blood glucose monitor features will also allow healthcare diabetesmatters.co.uk. (BGM) to seamlessly connect professionals to more efectively to the Apple iPhone® and iPad manage their patients remotely 1. Sanofi. Data on file GBIE. touch® was recently launched. as well as helping them to have BGS.12.01.07

April 2012 | Midlife and Beyond | GM