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BMD,DEXA, Osteoporosis, FRAX, Osteopenia, Cost effective, Drug treatment, Hip fractures, T-score.

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  1. 1. Osteoporosis More questions than answers Vinod Naneria Consultant orthopaedic surgeon Choithram Hospital & Research Centre Indore , India
  2. 2. Osteoporosis - Definition <ul><li>A conference was organized on osteoporosis in Rome on 22 nd – 25 th June,1992 by WHO, partnering with the International Osteoporosis Foundation, a nonprofit organization with a corporate advisory board that currently consists of 31 drug and medical-equipment companies. </li></ul>
  3. 3. Acknowledgements <ul><li>This meeting was organized by the WHO Collaborating Centre for Metabolic Bone Disease, Sheffield, England, the world health organization and the European Foundation for Osteoporosis and Bone Disease, with financial support from the Rorer Foundation, Sandoz Pharmaceuticals and Smith Kline Beecham. </li></ul><ul><li>The Study Group gratefully acknowledges the contribution made to the meeting By Professor G. Mazzuoli, Umberto I Polyclinic, Rome, Italy. </li></ul><ul><li>WHO technical services 843 - 1994 </li></ul>
  4. 4. Osteoporosis - Definition <ul><li>The World Health Organization defines osteoporosis as a &quot;progressive systemic skeletal disease characterized by low bone mass and micro-architectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture.&quot; WHO technical services 843 - 1994 </li></ul>Normal bone: T-score better than -1 Osteopenia: T-score between -1 and -2.5 Osteoporosis: T-score less than -2.5 Established osteoporosis: Presence of a non-traumatic fracture.
  5. 5. A disease created? <ul><li>In a single conference, one disease — osteoporosis — had been expanded from an elderly person with a fracture to anyone who had a -2.5 T-score. And another condition, Osteopenia, was created. </li></ul>
  6. 6. The Definition? <ul><li>In classic 1968 monograph, Wilson and Jungner defined for the World Health Organization (WHO) principles intended to serve as the basis for recommending or planning screening for early detection of a disease. </li></ul><ul><li>Can osteoporosis fall in the category of a disease? </li></ul>
  7. 7. WHO principles for recommending or planning screening for early detection of a disease <ul><li>The condition should be an important health problem.  Yes </li></ul><ul><li>There should be an accepted treatment for patients with recognized disease.  +/- </li></ul><ul><li>Facilities for diagnosis and treatment should be available.  No </li></ul><ul><li>There should be a recognizable latent or early symptomatic stage.  Silent Thief </li></ul><ul><li>There should be a suitable test or examination.  </li></ul><ul><li>? </li></ul>
  8. 8. WHO principles …. disease <ul><li>The test should be acceptable to the population.  What choice? </li></ul><ul><li>The natural history of the condition, including development from latent to declared disease, should be adequately understood.  Not understood well </li></ul><ul><li>There should be an agreed policy on whom to treat as patients.  No agreed policy </li></ul><ul><li>The cost of case-finding should be economically balanced in relation to possible expenditure as a whole.  Not cost effective </li></ul><ul><li>Case-finding should be a continuing process and not a &quot;once and for all&quot; project.  Case finding is once for all </li></ul>
  9. 9. Bad medicine: osteoporosis <ul><li>Osteoporosis is not a disease but a risk factor for fracture, particularly of the hip. </li></ul><ul><li>Age over 80 is by far the single greatest risk. </li></ul><ul><li>It is an assumption that “treatment” exists. </li></ul><ul><li>Limited evidence of the effectiveness of bisphosphonates in the primary prevention of hip fracture in people with no history of fracture, </li></ul><ul><li>Secondary prevention the small reduction in hip facture is again in highly selected elderly populations. </li></ul>Des Spence, general practitioner, Glasgow BMJ 2010;340:c643
  10. 10. Front line review – bad medicine <ul><li>The term osteoporosis is an age dependent concept; primary prevention is questionable in all but the most frail; and “osteopenia” should be struck from the medical lexicon. </li></ul><ul><li>Research carries the scars of big pharma, with relative risk reductions, non-clinical outcomes, and composite end points. </li></ul>Des Spence, general practitioner, Glasgow BMJ 2010;340:c643
  11. 11. Fear psychosis? <ul><li>↑ Cholesterol -> Coronary -> Myocardial infarct </li></ul><ul><li>↑ B.P. -> Hypertension -> Stroke </li></ul><ul><li>↑ Uric acid -> Gout -> Arthritis </li></ul><ul><li>↓ BMD -> Osteoporosis -> Fragility Fracture </li></ul>Risk Factor Disease Clinical expression WHO TRS 843_ 1994
  12. 12. HOPE SELLING
  13. 13. Ray Moynihan, journalist, Iona Heath, general practitioner, David Henry, professor of clinical pharmacology. BMJ 2002;324:886-891 <ul><li>The social construction of illness is being replaced by the corporate construction of disease. </li></ul><ul><li>A lot of money can be made from </li></ul><ul><li>healthy people who believe they are sick. </li></ul><ul><li>A lot of money can be made by </li></ul><ul><li>telling healthy people that they are sick . </li></ul>
  14. 14. Diagnosis by DEXA <ul><li>The burden of diagnosis was shifted from clinicians to machines. </li></ul><ul><li>Machines will decide who are at risk of fracture, and who needs treatment. </li></ul><ul><li>Machines of all types and make were permitted for primary screening. </li></ul><ul><li>Only DEXA was approved by WHO. </li></ul>
  15. 15. DEXA – Flaws? <ul><li>The WHO has defined the categories based on bone density in white women. </li></ul><ul><li>The WHO committee did not have enough data to create definitions for men or other ethnic groups. </li></ul><ul><li>There is no uniformity between various machines. </li></ul>Talk to your Physician or refer to your “Osteoporosis society” for further information.
  16. 16. DEXA– Flaws? <ul><li>DEXA overestimate the bone mineral density of taller subjects and underestimate the bone mineral density of smaller subjects. </li></ul><ul><li>In DEXA, bone mineral content is divided by the area of the site being scanned. </li></ul><ul><li>DEXA calculates BMD using area (aBMD: areal Bone Mineral Density), it is not an accurate measurement of true bone mineral density, which is mass divided by a volume. </li></ul>
  17. 17. DEXA– Flaws? <ul><li>The confounding effect of differences in bone size is due to the missing depth value in the calculation of bone mineral density. </li></ul><ul><li>The radiation dose is approximately 1/10th that of a standard chest X-ray </li></ul><ul><li>BMD testing with DXA is very susceptible to operator error. </li></ul>
  18. 18. DEXA– Flaws? <ul><li>A repeat BMD measurements should be done on the same machine each time, or at least a machine from the same manufacturer. </li></ul><ul><li>Error between machines, or trying to convert measurements from one manufacturer's standard to another can introduce errors large enough to wipe out the sensitivity of the measurements. </li></ul><ul><li>DEXA results need to be adjusted if the patient is taking strontium, and calcium supplements. </li></ul><ul><li>Metallic artifacts in cloths or pockets cause errors. </li></ul><ul><li>Osteomalacia, Osteoarthritis of spine, old Fractures of spine and hip, aortic calcification affect BMD readings. </li></ul>
  19. 19. BMD monitoring ? <ul><li>Osteoporosis is an arbitrary point on a scale, </li></ul><ul><li>Process of micro-architectural deterioration </li></ul><ul><li>Accelerated bone resorption exists throughout postmenopausal life, whereas osteoporosis does not. </li></ul><ul><li>Bone densitometry measures bone density, not bone turnover or bone stability. </li></ul><ul><li>85% of the rise in risk of fracture in ageing women is attributable to something other than the loss of BMD. </li></ul><ul><li>Age is a better predictor of hip fracture than radial bone density. </li></ul>
  20. 20. Do you know? Do you know what is your T – Score? Take one minute test! Do you know what are your chances of getting fractures in next 10 years? Go online FRAX site! For Treatment consult your physician or your “ Osteoporosis Society ”
  21. 21. Do you know your...Blood pressure? Cholesterol level? Weight? T-score? Program especially aimed at men and women in mid-40s to late 60s
  22. 22. Patient is at risk? <ul><li>White Caucasian Female </li></ul><ul><li>Countries with aging population </li></ul><ul><li>Countries with high numbers of population above the age of 65 years. </li></ul><ul><li>Countries with more female to male ratio </li></ul><ul><li>Country where female are living longer </li></ul>
  23. 23. Risk Factors – are they applicable to us? <ul><li>Female Non-modifiable </li></ul><ul><li>Age Non-modifiable </li></ul><ul><li>Genetics Non-modifiable </li></ul><ul><li>Incidence of RA? Non-modifiable </li></ul><ul><li>Corticosteroid? Non-modifiable </li></ul><ul><li>Smoking? Modifiable </li></ul><ul><li>Alcohol? Modifiable </li></ul><ul><li>BMI? Modifiable (Wt.) </li></ul>
  24. 24. 25 15 35 40 30 40 35 35 25 30 25 30 20 20 40 The global median age 2010 Be scared of 2050 Hip fractures in USA, Europe, & Oceania – 57% in the year 1990 Hip fractures in Asia, Africa, and South America will be 71% in 2050
  25. 25. Percentage of aging population of world 2010 <5% 9% 14% >15% >15% Be scared of 2050 Osteoporosis affects 75 million people in Europe, Japan and USA, and causes 2.3 million fractures annually in Europe and the USA alone.
  26. 26. Aging population of the world Look at Europe
  27. 27. Sex ratio of population aged over 65 years per country (2006 CIA World Fact book) smooth scale from blue to red: Blue: below 0.39 males/female White: 0.79 males/female (World) Red: above 1.29 males/female (Grey: no data) Male / Female ratio in world population
  28. 28. <ul><li>1.7 million hip fractures occurred in 1990 world over </li></ul><ul><li>Fractures rate vary by geographical regions. </li></ul><ul><li>Higher in Scandinavia than in USA or Oceania, and </li></ul><ul><li>lower in southern Europe. </li></ul><ul><li>Absolute number of fractures is determined by ethnic </li></ul><ul><li>composition, size & age distribution of the population. </li></ul><ul><li>Half of the hip fractures occur in Europe, USA and </li></ul><ul><li>Oceania, even though the population was smaller </li></ul><ul><li>(380 million of 35 years of age compared with 920 </li></ul><ul><li>million in Asia in 1990, because the population was </li></ul><ul><li>older and largely of whites. </li></ul><ul><li>About one third of hip fractures In 1990 occurred in </li></ul><ul><li>Asia, despite lower incidence rates among Asians. </li></ul>NORTH OLD & WHITE
  29. 29. India and the World <ul><li>Mean age 25 years. </li></ul><ul><li>Population above 65 is 9% </li></ul><ul><li>Male female ratio is above 1.29 </li></ul><ul><li>Average age of life expectancy is 64.7 </li></ul><ul><li>Average Female life expectancy is 66.4 </li></ul><ul><li>Average Female height is 5’ </li></ul>Dark skin in cold countries may be a cause of Vit D deficiency, not in India.
  30. 30. USA and Europe <ul><li>Mean age around 35 - 40 years </li></ul><ul><li>Population above 65 is 14 – 15% </li></ul><ul><li>Male female ratio is below -39 </li></ul><ul><li>Average age of life expectancy is 78.2 – 81 Yrs. </li></ul><ul><li>Average female life expectancy is 80.2 – 84 </li></ul><ul><li>Average female height is 5’.5” </li></ul>
  31. 31. Japan <ul><li>Japan has a highest number of elderly. </li></ul><ul><li>The osteoporotic fractures are 50% less. </li></ul><ul><li>Osteoporotic fractures are much less in the so called small, thin, low BMI Asians as compare to Americans (Caucasians). </li></ul><ul><li>Over all Life expectancy in Japan 82.6, </li></ul><ul><li>M/F Life expectancy- 79.0 for M & 86.1 for F </li></ul>
  32. 32. <ul><li>Country overall Male Female </li></ul><ul><li>1   Japan 82.6 79.0 86.1 </li></ul><ul><li>2   Hong Kong 82.2 79.4 85.1 </li></ul><ul><li>3   Iceland 81.8 80.2 83.3 </li></ul><ul><li>4   Switzerland 81.7 79.0 84.2 </li></ul><ul><li>5   Australia 81.2 78.9 83.6 </li></ul><ul><li>6   Spain 80.9 77.7 84.2 </li></ul><ul><li>7   Sweden 80.9 78.7 83.0 </li></ul><ul><li>8   Israel 80.7 78.5 82.8 </li></ul><ul><li>9   Macau 80.7 78.5 82.8 </li></ul><ul><li>10 France  80.7 77.1 84.1 </li></ul><ul><li>11 United States 78.2 75.6 80.8 </li></ul><ul><li>12 India 64.7 63.2 66.4 </li></ul><ul><li>13 World 67.2 65.0 69.5 </li></ul>In spite of Osteoporosis women are living long by 4 to 7 yrs.
  33. 33. The United Nations 2005-2010 <ul><li>Women tend to have a lower mortality rate at every age. In the womb, male fetuses have a higher mortality rate. </li></ul><ul><li>Babies are conceived in a ratio of about 124 males to 100 females, but the ratio of those surviving to birth is only 105 males to 100 females. </li></ul>
  34. 34. The United Nations 2005-2010 <ul><li>Among the smallest premature babies (those under 2 pounds or 900 g) females again have a higher survival rate. </li></ul><ul><li>At the other extreme, about 90% of individuals aged 110 are female. </li></ul><ul><li>1 : 30 F/M ratio of Cardiac event during child bearing age. </li></ul><ul><li>1 : 9 F/M ratio of Cardiac event after 65 yrs. </li></ul><ul><li>Mortality with in one year following fractures is 37.5% higher in males. </li></ul>
  35. 35. Internet Data's on Osteoporosis <ul><li>About 48,900,000 articles are published in Google. as of today (5 th Sept.2010) </li></ul><ul><li>In Pubmed  50,145 </li></ul><ul><li>Review articles 11,842 </li></ul><ul><li>Full text free articles 7,155 </li></ul><ul><li>Books on Google 1,170,300 </li></ul><ul><li>Amazon 2,991 </li></ul>
  36. 36. What Every Orthopaedic Surgeon Should Know? Richard M. Dell, Bone Joint Surg Am. 2009;91 Suppl 6:79-86 d <ul><li>8 million women and 2 million men in the US. </li></ul><ul><li>34 million Americans have low bone mass. </li></ul><ul><li>1.5 million fragility fracture each year </li></ul><ul><li>18 billion dollars as an annual cost of treatment. </li></ul>Endocrinologist, Internal Medicine, Rheumatologist, & G.P. Know Osteoporosis in East, is treated by Orthopedic surgeons Need for reminder
  37. 37. What Every Orthopaedic Surgeon Should Know? Richard M. Dell, Bone Joint Surg Am. 2009;91 Suppl 6:79-86 d <ul><li>Reaching epidemic proportions. </li></ul><ul><li>75 million baby boomers entering the age of risk for osteoporosis. </li></ul><ul><li>One-half of all women and one-third of all men will sustain a fragility fracture during their lifetime . </li></ul>Gynecologist, Oncologists, geriatrists, & Celebrities know Need for reminder Orthopedic Surgeons
  38. 38. Internet data starts with American... <ul><li>An introduction of numbers of &quot;Americans&quot; having Osteoporosis. (12 millions) </li></ul><ul><li>A projected raise in numbers in the year 2020, and 2050. (44 millions) </li></ul><ul><li>All of them have calculated the &quot;Cost&quot; of fracture treatment today and tomorrow in Dollars. </li></ul><ul><li>All have projected fracture of hips solely due to osteoporosis (1.5 - 2 millions/ Yr). </li></ul>
  39. 39. America….. <ul><li>The total population of America 30 crores. </li></ul><ul><li>The population 65 and above 37 m (13%) </li></ul><ul><li>Females population 65 and above 18 m </li></ul><ul><li>Patient population 12 millions </li></ul><ul><li>75 million Baby Boomers reaching above 60. </li></ul><ul><li>Osteoporosis related fractures 1.5 – 2m. </li></ul><ul><li>Basic white American (Caucasians) problem. </li></ul><ul><li>Declared osteoporosis as National problem in 1984. </li></ul>
  40. 40. All agree to American……… <ul><li>Caucasians are more prone, </li></ul><ul><li>General deficiency of vitamin D and calcium, </li></ul><ul><li>Acute need for change in the diet. </li></ul><ul><li>Change in life style: sun exposure, smoking, alcohol, and exercises. </li></ul><ul><li>Almost all have calculated the amount of Calcium and Vit.D on the basis of how much is their daily intake, how much they are absorbing and how much they are excreting / retaining. </li></ul>
  41. 41. All agree to American……… <ul><li>Climatic conditions: Boston less sun exposure than Miami. </li></ul><ul><li>Diet :- Low calcium, high animal protein, and high sodium, less of dairy products. </li></ul><ul><li>Sun exposure: Melanoma very high. </li></ul><ul><li>2 million new cases and 84,000/ death. </li></ul><ul><li>Use of sun protection cream. </li></ul><ul><li>Fortified Milk have high proteins and hence cause more calcium loss in urine. </li></ul>
  42. 42. Asian Women <ul><li>Asian women have lower bone mass than Caucasian women, but, the rate of hip fractures is not proportionally higher. </li></ul><ul><li>Theories: shorter hip-axis length, </li></ul><ul><li>Previous activity levels that were higher, </li></ul><ul><li>The cultural practice of taking care of the elderly, </li></ul><ul><li>Not allowing them to leave their beds - reducing the opportunity for falling. </li></ul>
  43. 43. How Big Is ASIA
  44. 44. Is Asia is comparable? <ul><li>1/3 rd world live in Asia. </li></ul><ul><li>From Bali island in south to Siberia and Mongolia in north, from Japan in the east to Iran in the west. </li></ul><ul><li>The climatic condition and food habits differs markedly. </li></ul><ul><li>The sun exposure, protein diet, skin color, height and weight differ, which changes their demand for calcium and Vit D. </li></ul><ul><li>Differ genetically from Caucasians. </li></ul>
  45. 45. Are these criteria applicable to all races, age group and gender? <ul><li>The WHO criteria are derived from Caucasian postmenopausal women population and are, thus, best applicable to that group. However, in the absence of normative data from other races, WHO criteria have been widely accepted and used in clinical practice. Normative data for Indians are not available. It is possible that if we use the WHO criteria substantial number of patients may be over diagnosed and over treated. </li></ul><ul><li>ACTION PLAN OSTEOPOROSIS CONSENSUS STATEMENT – Osteoporosis Society of India New Delhi, 2003. </li></ul>
  46. 46. Disease expands through marriage of marketing and machines A sidewalk sign at Kelley-Ross Pharmacy in Seattle advertises bone-density screening. Such screening has proliferated in recent years, targeting younger, healthier people. BETTY UDESEN / THE SEATTLE TIMES
  47. 47. Who should be screened? <ul><li>Over the last decade - many debates. </li></ul><ul><li>Several organizations performed detailed cost-benefit studies and developed guidelines. </li></ul><ul><li>U.S. Preventive services Task Force, American Association of Clinical Endocrinologists, National Osteoporosis Foundation. </li></ul>
  48. 48. Who should be screened? <ul><li>Problem of over-interpretation of results, & healthy average people think they are at a much higher risk. </li></ul><ul><li>In 2000 an NIH consensus conference concluded: &quot;Until there is good evidence to support the cost-effectiveness of routine screening, or the efficacy of early initiation of preventive drugs, an individualized approach is recommended. </li></ul>
  49. 49. Bone density at various sites for prediction of hip fractures Cummings SR, Black DM, Nevitt MC, Browner W, Cauley J, Ensrud K, et al . The Study of Osteoporotic Fractures Research Group.  Lancet  1993; 34: 72-75 . <ul><li>BMD poor predictor of fractures. </li></ul><ul><li>When different scanners are used on the same patients, the proportion of patients diagnosed with osteoporosis varies from 6% up to 15%. </li></ul><ul><li>Over 80% of low trauma fractures occur in people who do not have osteoporosis (T score  –2.5).   </li></ul>
  50. 50. Bone density at various sites for prediction of hip fractures <ul><li>Even if a T score of –1.5 is used 75% of fractures would still occur in people without osteoporosis.  </li></ul><ul><li>BMD gives general practitioners little indication which patient will sustain a fracture. </li></ul><ul><li>Changes in bone density in people taking antiresorptive drugs explain only 4-30% of the reduction in risk of vertebral and non-vertebral fractures. </li></ul>
  51. 51. Bone density at various sites for prediction of hip fractures <ul><li>With each standard deviation decrease in femoral neck bone density, there is a 2.6 times increase in the age adjusted risk of hip fracture. </li></ul><ul><li>Women with bone density in the lowest quarter had an 8.5-fold greater risk of hip fracture than those in the highest quarter. </li></ul><ul><li>The data are based on just 65 women who sustained a fracture out of 8134 observed.  </li></ul>
  52. 52. Bone density at various sites for prediction of hip fractures <ul><li>Treatment of the entire 8000 with an antiresorptive drug (assuming acceptance, compliance, and a budget) could be expected to save a maximum 33 fractures (a generous estimate as the 50% reduction in fractures claimed for bisphosphonates is based on populations already selected for low bone density or existing fracture). </li></ul>
  53. 53. Bone density at various sites for prediction of hip fractures <ul><li>Alternatively, 8000 scans to classify the 2000 women in the lowest quarter of bone density would, according to the trial data, identify only 34 of the 65 who suffered fractures, and only half (or 17) of these fractures could be prevented by drugs. </li></ul><ul><li>Bone densitometry can tell us about populations, but the chances of predicting a preventable fracture by bone densitometry in an osteoporosis clinic of largely self referred individuals must be close to random. </li></ul>
  54. 54. Bone densitometry is not a good predictor of hip fracture BMJ  2001;323:795-799. Education and debate: For and against Terence J Wilkin, Devasenan Devendra  <ul><li>The ability of bone densitometry to predict future fracture is overstated, and the data on which such claims are based are over interpreted. </li></ul><ul><li>Bone densitometry is a major industry (an estimated 34 000 densitometry machines were in existence worldwide in the year 2000),  </li></ul><ul><li>And much of the research into osteoporosis depends on it. </li></ul><ul><li>Clinical trials test efficaciousness (can it work?) in selected groups. The clinician is concerned with effectiveness (does it work?) in unselected individuals. The challenge is to show the latter. </li></ul>
  55. 55. Screening for postmenopausal osteoporosis Nelson HD, Helfand M, Woolf SH, Allan JD Ann Intern Med 2002;137:529-41. <ul><li>When different scanners are used on the same patients, the proportion of patients diagnosed with osteoporosis varies from 6% up to 15%. </li></ul><ul><li>This means that a patient with a bone mineral density T score of –1.5 may have a true value between –3.0 and 0–that is, a range from clear osteoporosis to normal. </li></ul><ul><li>Bone mineral density is a poor predictor of fracture in individuals. </li></ul>
  56. 56. BMD Screening - Cost Effective? <ul><li>The WHO task force on osteoporosis management agrees that screening by densitometry before the age of 65 is not cost effective.  </li></ul><ul><li>But screening of high risk patients (case finding through education) is thought to be cost effective, in particular at age 70 in people who already have a low bone mass together with other risk factors such as low body weight, previous fracture, or family history.  </li></ul>Conclusion: Although methods to identify risk for osteoporotic fractures are available and medications to reduce fractures are effective, no trials directly evaluate screening effectiveness, harms, and intervals. U.S. Preventive Services Task Force: Heidi D. Nelson, 2010,
  57. 57. NOF recommendations <ul><li>National Osteoporosis Foundation US and the American Association of Clinical Endocrinologists recommend routine monitoring of bone mineral density within two years of starting treatment. </li></ul><ul><li>The UK National Osteoporosis Guidelines Group, US National Institutes of Health, and the Osteoporosis Society of Canada do not make a recommendation either way on monitoring . </li></ul>NHS no recommendation
  58. 58. Recommendations… <ul><li>Monitoring bone mineral density in postmenopausal women in the first three years after starting treatment with a potent Bisphosphonate is unnecessary and may be misleading. Routine monitoring should be avoided in this early period after Bisphosphonates treatment is commenced. </li></ul>Research: Value of routine monitoring of bone mineral density after starting bisphosphonate treatment: secondary analysis of trial data; Katy J L Bell ,  Andrew Hayen ,  Petra Macaskill ,  Les Irwig ,  Jonathan C Craig ,  Kristine Ensrud ,  Douglas C Bauer , Published 23 June 2009, doi:10.1136/bmj.b2266, :  BMJ 2009;338:b2266.
  59. 59. Meta-analysis of how well measures of bone mineral density predict occurrence of osteoporotic fractures Deborah Marshall, Olof Johnell, Hans Wedel, BMJ 1996;312:1254-1259 (18 May)  <ul><li>Measurements of bone mineral density can predict fracture risk but cannot identify individuals who will have a fracture. </li></ul><ul><li>We do not recommend a program of screening menopausal women for osteoporosis by measuring bone density.  </li></ul>
  60. 60. Fractures – Fall? or BMD? <ul><li>Prevention of fall prevent 15 to 50% fractures </li></ul><ul><li>Exercises, Strength and balancing training </li></ul><ul><li>Reduction of anti-psychotic drugs </li></ul><ul><li>Dietary supplementation of Vit D +Calcium </li></ul><ul><li>Modification at Home </li></ul><ul><li>Visual impairment correction </li></ul><ul><li>Cognitive function </li></ul><ul><li>Cardiac pacing where indicated, </li></ul><ul><li>Use of gait stabilizing, </li></ul><ul><li>Hip protectors. (23-60%). </li></ul><ul><li>Antiskid devices when walking outdoors. </li></ul>
  61. 61. Streamlining assessment and intervention in a falls clinic using the timed up and go test and physiological profile assessments. Whitney JC, Lord SR, Close JC. Age Ageing  2005;34:567-71 <ul><li>People who have difficulty in performing a simple sit to stand test or taking over 13 seconds to complete a simple timed &quot;up and go test“ should be referred to a geriatrician or falls clinic for a more comprehensive evaluation. </li></ul><ul><li>Fall prevention is a better method to prevent fractures than BMD. </li></ul>
  62. 62. A fall to the side increases the risk of hip fracture by about 6 times, compared to falls in other directions.
  63. 63. Fractures -> Fall? or BMD? <ul><ul><li>Falling, not osteoporosis, is the strongest single risk factor for fractures in elderly people. </li></ul></ul><ul><ul><li>Bone mineral density is a poor predictor of an individual’s fracture risk. </li></ul></ul><ul><ul><li>Drug treatment is expensive and will not prevent most fractures in elderly people. </li></ul></ul><ul><ul><li>Randomized controlled trials show that falls in older people can be reduced by up to 50%. </li></ul></ul>BMJ  2008;336:124-126 (19 January), doi:10.1136/bmj.39428.470752.AD
  64. 64. Go for BMD Go for FRAX One minute test Fracture Index Absolute fracture risk 13 seconds to complete &quot;up and go test“ Watch. Be careful. Don't fall Osteoporosis ahead!
  65. 65. FRAX- 10 year risk of fragility fracture <ul><li>Age, Sex, Height, Weight, </li></ul><ul><li>Previous fracture, </li></ul><ul><li>Family history of fracture, </li></ul><ul><li>Smoking, Alcohol, </li></ul><ul><li>Rheumatoid, Corticosteroid, </li></ul><ul><li>Secondary Osteoporosis </li></ul><ul><li>BMD </li></ul>
  66. 67. Dr. Judith Brenner: power of FRAX tool <ul><li>Using FRAX, the risk a hip fracture within 10 years for a 60-year-old white woman of 5 feet and 110 pounds, with no family or personal history of fracture and no history of smoking or using steroids is 1.5 percent. </li></ul><ul><li>If the same woman instead weighed 200 pounds, her risk would drop to 0.5 percent. </li></ul><ul><li>But if the 110-pound woman had a parent who suffered a hip fracture, her risk would rise to 1.9 percent. </li></ul><ul><li>Add smoking, and the risk goes to about 2.9 percent. </li></ul><ul><li>Add steroids, and the risk rises to 5.9 percent. </li></ul>
  67. 68. Dr. Judith Brenner New York University power of the FRAX tool <ul><li>Add daily consumption of two or more alcoholic drinks, and the risk becomes 9 percent. </li></ul><ul><li>Instead of 60, say the woman is 80 years old, slender and with no family or personal history of fractures, smoking or steroid use. Dr. Brenner calculated her risk of fracturing a hip in 10 years as 10 percent and of having any major osteoporotic fracture at 35 percent. </li></ul>
  68. 69. Pre-Osteoporosis or Osteopenia? <ul><li>Osteopenia was defined in June 1992 by the World Health Organization. </li></ul><ul><li>It was meant to indicate the emergence of a problem. </li></ul><ul><li>It didn't have any particular diagnostic or therapeutic significance at that time. </li></ul>“ We never imagined that people would come to think of Osteopenia as a disease in itself to be treated.” Dr. John A Kanis, emeritus professor of medicine University of Sheffield , England, Director of the WHO center that defined BMD & developed FRAX.
  69. 70. Implications Of Expanding Disease Definitions: The Case Of Osteoporosis M. Brooke Herndon, Lisa M. Schwartz, Steven Woloshin and H. Gilbert Welch <ul><li>The new threshold changes the number of women for whom treatment is recommended from 6.4 million to 10.8 million among women age sixty-five and older (at a net cost of at least $28 billion) and from 1.6 million to 4.0 million among women ages 50–64 (at a net cost of at least $18 billion). </li></ul><ul><li>Whether or not offering treatment to these additional women will reduce the number of hip fractures is unknown. </li></ul>
  70. 71. Selling sickness: how drug companies are turning us all into patients. Moynihan R, Cassels A. BMJ 2002;324:886-91 Sydney: Allen and Unwin, 2005 <ul><li>Osteoporosis is a controversial condition. An informal global alliance of drug companies, doctors, and sponsored advocacy groups portray and promote osteoporosis as a silent but deadly epidemic bringing misery to tens of millions of postmenopausal women. For others, less entwined with the drug industry, that promotion represents a classic case of disease mongering—a risk factor has been transformed into a medical disease in order to sell, tests, and drugs to relatively healthy women. </li></ul>
  71. 72. Drugs for pre-osteoporosis: prevention or disease mongering? <ul><li>To treat 133 (95% confidence interval 104 to 270) women for three years to prevent a single vertebral fracture. In other words, up to 270 women with pre-osteoporosis might need to be treated with drugs for three years so that one of them could avoid a single vertebral fracture. </li></ul>
  72. 73. Steven R. Cummings, University of California, San Francisco 2003, JAMA. 2006;296:2601-2610. <ul><li>There is no basis, no biological, social, economic or treatment basis, no basis whatsoever. </li></ul><ul><li>As a consequence, though, more than half of the population is told arbitrarily that they have a condition they need to worry about. </li></ul><ul><li>Osteopenia is not a disease and the label can cause unnecessary anxiety. </li></ul><ul><li>Osteopenia by itself is not an indication for treatment. </li></ul>
  73. 74. Osteopenia: To Treat or Not To Treat? Michael R. McClung, MD, Annals of Internal Medicine: May 3, 2005vol. 142 no. 9 796-7 <ul><li>Fracture risk depends not on BMD value. </li></ul><ul><li>Independent risk factors are </li></ul><ul><ul><li>age, </li></ul></ul><ul><ul><li>previous fracture, </li></ul></ul><ul><ul><li>the tendency to fall. </li></ul></ul><ul><ul><li>BMD in older women are at substantially greater risk for fracture than younger postmenopausal women. </li></ul></ul><ul><ul><li>Moreover, younger postmenopausal women are more likely to have fractures of the forearm or lower leg than the more serious hip and spine fractures experienced by elderly patients. </li></ul></ul>
  74. 75. Osteopenia: To Treat or Not To Treat? <ul><li>The diagnostic category of osteopenia in individual patients does not serve the clinical community well. </li></ul><ul><li>Bone density measurement remains an important tool in assessing skeletal health, </li></ul><ul><li>The determinants of fracture are complex and interesting than simply the T-score. </li></ul><ul><li>The objective of using osteoporosis drugs is to prevent fractures. </li></ul><ul><li>This can be accomplished only by treating patients who are likely to have a fracture, not by simply treating T-scores. </li></ul>
  75. 76. Drugs for pre-osteoporosis: prevention or disease mongering? <ul><ul><li>Drug treatment reduce the risk of fracture in women with Osteoporosis. </li></ul></ul><ul><ul><li>Drug marketing is being directed at women with Osteopenia with a low risk of fracture. </li></ul></ul><ul><ul><li>The rationale for this strategy comes from questionable post-hoc re-analyses that understate side effects and overstate potential benefits. </li></ul></ul>
  76. 77. Change a number, create a patient <ul><li>The number of people with at least one of four major medical conditions has increased dramatically in the past decade because of changes in the definitions of disease. &quot;The new definitions ultimately label 75 percent of the adult U.S. population as diseased,&quot; according to calculations by two Dartmouth Medical School researchers. </li></ul>Suddenly sick: A special report by Susan Kelleher and Duff Wilson · June 26 - June 30, 2005
  77. 78. The Number Game Source: “Changing Disease Definitions: Implications for Disease Prevalence,” Dr.Lisa Schwartz and Steven Woloshin, Effective Clinical Practice, March/April 1999. Diagnosis Old Definition New definition People under Old People under New % increase Year Diabetes Fasting Sugar > 140mg/dl Fasting > 126mg/dl 11.7 M 1.7 M 14% 1997 Hypertension BP > 160/100 BP> 140/90 38.7 M 13.5 M 35% 1997 Cholesterol > 250mg/dl > 200mg/dl 49.5 M 42.6 M 86% 1998 Obesity (BMI) BMI> 27kg/m ² BMI> 25kg/m ² 70.6 M 30.5 M 43% 1998 Pre hypertension Nil 120/80 to 139/89 Nil 45 M - 2003
  78. 79. Osteoporosis - treatment (and prevention of fragility fractures) - Management NICE review Suspended? <ul><li>National Institute for Health and Clinical Excellence (NICE) UK was assessing the cost effectiveness of different interventions in the primary and secondary prevention of osteoporotic fractures in 2006 has suspended the project for preparing guidelines for treatment of osteoporosis, as experts could not come to any conclusion after going through various published reports on the management of osteoporosis. </li></ul>
  79. 80. Fast Track <ul><li>The absolute fracture risk in 50 yr woman with T score –3 is same that of an 80 yr old woman with a T score of –1. </li></ul><ul><li>MORE trial :  The prevalence of fractures (not rate) is far greater with Osteopenia </li></ul><ul><li>ROTTERDAM trial: 12 % of non-vertebral fractures were in women with normal BMDs </li></ul><ul><li>NORA trial:  Of postmenopausal women who suffered a new fracture within 1 year, 82% had Osteopenia </li></ul>
  80. 81. The Industry <ul><li>Since 2003, annual sales of osteoporosis drugs have about doubled to $8.3 billion, according to Kalorama Information, a provider of market research on medicine.  </li></ul><ul><li>After a few years, peak sales of any effective osteoporosis agent could reach well over $1 billion,&quot; said McDonald. </li></ul><ul><li>Market sales are predicted to reach $10.4 billion by 2011. </li></ul>
  81. 82. The Industry… <ul><li>&quot;Should the drug makers and their shareholders be worried about overcrowding? No, according to Lehman Brothers analyst Anthony Butler, because there is &quot;no lack&quot; of patients needing drugs for osteoporosis treatment. </li></ul><ul><li>A bone drug battle ahead? Seven bone ailment blockbusters could crowd the market in 2007, analysts say. By Aaron Smith, CNN/Money staff writer </li></ul>
  82. 83. Time Line - Fosamax <ul><li>Fosamax Sales </li></ul><ul><li>1996 $ 282 millions </li></ul><ul><li>1997 $ 531 millions </li></ul><ul><li>1998 $ 775 millions </li></ul><ul><li>1999 $ 1.04 billions </li></ul><ul><li>2000 $ 1.2 billions </li></ul><ul><li>2001 $ 1.6 billions </li></ul><ul><li>2002 $ 2.2 billions </li></ul><ul><li>2003 $ 2.7 billions </li></ul><ul><li>2004 $ 3.0 billions </li></ul><ul><li>Sources: Food and Drug Administration, World Health Organization, Securities and Exchange Commission, Preventive Services Task Force, Science magazine </li></ul>1999 – WHO panel recommends ways to measure osteoporosis burden on health systems but fails to disclose that eight of the 11 panelists were employed by drug companies.
  83. 84. Create a non-profit organization “ Bone Measurement Institute”  . Set up own factory to manufacture small, portable peripheral scanning machines. & make machines affordable for individual doctors and clinics. Tie-ups with other manufacturers. lobby directly or through other organizations to governments to pass legislation allowing medical insurance plans. Create  Direct To Consumer  TV commercials. Own scientific journals,, write or help in writing articles, and sponsor articles in reputed journals. Formation of National and International “Societies” & “Foundations” of Bone, Bone and Mineral,, Densitometry, Osteoporosis, and Calcified Tissue. Event creation like Bone and joint decade, and world osteoporosis day. Game Plan
  84. 85. <ul><li>“ Menopause is the single most important cause of osteoporosis”. Merck’s targeted aids and brochures at younger women. </li></ul><ul><li>The U.S. FDA warned Merck in 1997 to stop this campaign. </li></ul><ul><li>Congress passed the “Bone Mass Measurement Act in 1997”. It authorized Medicare to reimburse doctors for performing bone-density tests, opening the door to coverage by other insurers. </li></ul>Merck - Menopause & Osteoporosis
  85. 86. Disease expands through marriage of marketing and machines <ul><li>Merck pushes bone-measurement technology into doctors' offices. </li></ul><ul><li>Merck promoted portable bone-measuring devices for office use. </li></ul><ul><li>Merck helped peripherals by funding trials and assisting doctors with submissions. </li></ul><ul><li>By -   Susan Kelleher · Seattle Times staff reporter </li></ul><ul><li> </li></ul>June 28, 2005
  86. 87. Marrying machine to medicine <ul><li>Merck bought the exclusive rights to one company's bone-testing technology. </li></ul><ul><li>Merck gave loan to another company to help develop a different machine. </li></ul><ul><li>Merck financed two other firms to increase the number of machines in doctors' offices. </li></ul><ul><li>Merck also created a leasing program so that doctors could finance the purchase of a machine, large or small. </li></ul>
  87. 88. Merck establishes new, nonprofit Bone Measurement Institute : WEST POINT, Pa., Aug. 31, 1995/PRNewswire. <ul><li>&quot;The Bone Measurement Institute will conduct activities to help increase the availability of bone measurement technologies, increase their accessibility to physicians and reduce the cost of bone mass measurement to health care payers,“. It also will provide educational support to physicians about the role of bone measurements and promote scientific research and development of bone testing methodologies. </li></ul>Super sale’s Man Jeremy Allen
  88. 89. Bone Measurement Institute On its board were six of the most respected osteoporosis researchers in the country. The institute itself had a rather slim staff: Jeremy Allen was the only employee. &quot;There was no payroll, there was no building, there was no office with the name 'Bone Measurement Institute,’ Allen says. Essentially Allen's desk at Merck was the only physical space the Bone Measurement Institute actually inhabited. &quot;I was it,&quot; he says.
  89. 90. Merck + CompuMed + Norland Deal 1/1/1996 -Executive summary <ul><li>CompuMed (devices and computer technology for measuring physiological parameters) has licensed exclusive worldwide rights to its OsteoGram bone mineral density testing technology to Merck & Co. 's non-profit subsidiary Bone Measurement Institute . </li></ul><ul><li>Norland Medical Systems, Inc. + Merck Business Wire, Feb 25, 1997 - The objective of the agreement is to accelerate placement of peripheral bone measurement devices in physicians' offices and clinics. </li></ul>
  90. 91. A diagnosis was born <ul><li>Medicare claims for screening exams increased from 77,000 in 1994 to more than 1.5 million annually by 1999. </li></ul><ul><li>The sale of peripheral machines went up more than 500 percent over the same period of time. And through this process of testing and advertising eventually a cultural consensus took hold. </li></ul><ul><li>Osteopenia simply became a condition that was seriously considered for treatment. </li></ul><ul><li>A diagnosis was born. </li></ul>Annual bone density screening rates in North America  increased by 263% from 2002 to 2007 & people on Fosamax had increased by 153%.  Game plan worked
  91. 92. JAMA's Fosamax study funded by Merck By - Martha Rosenberg, Writer Jan 9, 2007 <ul><li>&quot;Effects of Continuing or Stopping Alendronate After 5 Years of Treatment,&quot; in the December 27, 2006, issue of JAMA was funded and &quot;supported by contracts with Merck and Co.,&quot; according to JAMA, it &quot;was designed jointly by the non-Merck investigators and Merck employees&quot;  and written &quot;with editorial input from Merck throughout the process.“ </li></ul><ul><li>The study's 11 non-Merck authors disclosed 40 research grants, consultancies and other financial relationships with drug companies including Eli Lilly, Pfizer, Roche, SmithGlaxoKline, Wyeth, Novartis, Procter & Gamble and, of course, Merck. </li></ul><ul><li>Three Merck authors disclosed they &quot;potentially own stock and/or stock options&quot; </li></ul>
  92. 93. Fosamax – Insufficiency fractures <ul><li>A Merck-funded review paper published in the  NEJM on March 24, 2010 concludes: </li></ul><ul><li>“ The occurrence of fracture of the subtrochanteric or diaphyseal femur was very rare, even among women who had been treated with bisphosphonates for as long as 10 years.” </li></ul><ul><li>“ The study was underpowered for definitive conclusions.” </li></ul>Give drug a “HOLYDAY” after 3 – 5 Yrs .
  93. 95. The Hip Fractures? Very high morbidity, mortality, and financial impact. <ul><li>325,000 patients sustain a hip fracture each year. </li></ul><ul><li>25% will enter a nursing home. </li></ul><ul><li>50% will never reach their previous functional capacity. </li></ul><ul><li>25% will die within the first year after the fracture. </li></ul>Age : 75 to 85 + Co morbidity
  94. 96. The variables - Hip fractures <ul><li>Different in different ethnic groups, </li></ul><ul><li>Geographical locations, </li></ul><ul><li>Genetic determinants of height and weight, </li></ul><ul><li>Life style and social structure, </li></ul><ul><li>Aging population, </li></ul><ul><li>Life expectancy, </li></ul><ul><li>And Female/ Male ratio in the population. </li></ul>
  95. 98. Hype about hip fractures? Published in The New York Times, May 10, 2010, Company With Osteoporosis Treatment Wins the ‘Super Bowl’ By LORA KOLODNY Courtesy of McCombs School of Business, Texas Venture Labs Biologics MD team competing at Global Moot Corp.
  96. 99. Incidence of hip fractures ↓ <ul><li>Hip Fracture Rates Decline In Canada. </li></ul><ul><li>1985 – 2006 over the 21 years, rates of hip fracture declined 31.8 percent in females and 25 percent in males. </li></ul><ul><li>The largest percentage decrease was observed among individuals age 55 to 64 years; hip fracture rates decreased by almost one-half in females and about one-third in males in this age range . </li></ul><ul><li>Overweight and obesity may contribute to reduced fracture rates . </li></ul>William D. Leslie, M.D., M.Sc., of the University of Manitoba, Winnipeg, Canada JAMA.  2009;302[8]:883-889.
  97. 100. Hip fractures on decline ↓ <ul><li>In Australia, 1997-98 and 2006-07 years period, the incidence rate for osteoporotic hip fracture decreased by 14% for men and by 20% for women. </li></ul><ul><li>In the United States, hip fracture rates and subsequent mortality among persons 65 years and older are declining. Carmen A. Brauer- JAMA.  2009;302(14):1573-1579. </li></ul><ul><li>Declining hip fracture rates in the United States Age and Ageing 2010 39(4):500-503; doi:10.1093/ageing/afq044 -Judy A. Stevens  and Rose Anne Rudd. </li></ul>
  98. 101. Hip fractures on decline ↓ <ul><li>Nationwide Decline in Incidence of Hip Fracture in Finland </li></ul><ul><li>Pekka Kannus et al. J Bone Miner Res 2006;21:1836–1838. Published online on August 28, 2006; doi: 10.1359/JBMR.060815 </li></ul><ul><li>Declining incidence of hip fractures and the extent of use of anti-osteoporotic therapy in Denmark 1997-2006. Osteoporosis Int. 2010 Mar;21(3):373-80. Epub 2009 May 13. Abrahamsen B, Vestergaard P. </li></ul>
  99. 102. Fewer Hip fractures: A study of Canadian Hospital data found that rates of hip fractures have declined significantly over past two decades. Source: JAMA, 2009;302[8]:883-889. Published in The New York Times
  100. 103. Treatment and controversy <ul><li>T-score between -1.0 and -2.5 at the femoral neck or spine and a 10-year probability of hip fracture ≥3%  or  a 10-year probability of major osteoporotic fracture ≥10%. </li></ul><ul><li>Actual benefits of drugs may be marginal. </li></ul><ul><li>Approximately 270 women with osteopenia might need to be treated with drugs for three years so that one of them could avoid a single vertebral fracture. </li></ul>BMJ  2008;336:126-129 (19 January), doi:10.1136/bmj.39435.656250.AD
  101. 104. Incidence of clinically diagnosed vertebral fractures Cooper C, Atkinson EJ, O'Fallon WM, Melton LJ J Bone Miner Res  1992;7:221-7 <ul><li>Although most fractures due to osteoporosis present clinically, vertebral fractures may be asymptomatic in as many as two thirds of patients. </li></ul><ul><li>Although osteoporosis indicates a high likelihood of fracture, many fragility fractures occur in people with bone density values above the defined level. </li></ul>
  102. 105. Osteoporosis – a deficiency state? <ul><li>Osteoporosis is now more of a deficiency disease rather than a metabolic adjustment. </li></ul><ul><li>Vit D + Calcium supplementations in early life for higher peak bone mass? </li></ul><ul><li>No convincing literature on protective effect of supplementations start early in pre or post menopause. </li></ul><ul><li>Benefit in terms of reduced fracture risk has been quoted for home bound population above the age of 65 years. </li></ul><ul><li>Vit D helps in fall prevention due to better muscle strength. </li></ul>
  103. 106. Bisphosphonates have reduced vertebral fractures in clinical   trials of efficacy when about 90% of patients complied with   three years of treatment.  However, if a T score of  –2.5   is used as the indication for treatment, the cost of preventing   one vertebral fracture is about £23 500, and 70%   of fractures would still occur in the population. Adjusting   the threshold to treat more people would sharply increase the   costs per averted fracture. Drug treatment is not a panacea
  104. 107. What is not Talked - Fosamax <ul><li>Less than 1% absorption by oral intake. </li></ul><ul><li>Immediate attachment to Hydroxyapatite. </li></ul><ul><li>Excretion by Kidney. </li></ul><ul><li>Cardiac check up – Atrial Fibrillation </li></ul><ul><li>Renal check up – Retention in the body </li></ul><ul><li>Dental check up – Osteonecrosis of Jaw </li></ul><ul><li>GI check up – Oesophagitis, Gastritis, Ca. </li></ul><ul><li>Metabolic check up – Hypocalcaemia. </li></ul>
  105. 108. What is not Talked - Fosamax <ul><li>No known Metabolism of the drug in Vivo. </li></ul><ul><li>Remains in body for ever and goes for recycling? </li></ul><ul><li>Insufficiency fractures. </li></ul><ul><li>Immediate Osteoclasts apoptosis. </li></ul><ul><li>Osteoblastic activity continues. </li></ul><ul><li>Mineralization and maturation take long time. </li></ul><ul><li>Increased BMD is due to non absorption of hydroxyapatite and continued mineralization. </li></ul><ul><li>Increased mineral content with diminished elasticity, increased brittleness. </li></ul>
  106. 109. Cost-Effectiveness of Alendronate Therapy for Osteopenic Postmenopausal Women John T. Schousboe, MD, MS; Annals of Internal Medicine May 3, 2005vol. 142 no. 9 734-741 <ul><li>Alendronate therapy for postmenopausal women with femoral neck T-scores better than −2.5 and no history of clinical fractures or other bone mineral density-independent risk factors for fracture is not cost-effective, assuming U.S. costs of alendronate and currently available estimates of alendronate efficacy in osteopenic women. </li></ul>
  107. 110. Under idealized circumstances,   577 postmenopausal women must be treated for one year to avert   one hip fracture, at a cost of about £120 000. Among   women older than 80 (a high risk population), for whom drug   therapy would theoretically be most effective, prevention of   one hip fracture costs about £28 500. This case-finding   strategy, however, would prevent only about 20% of hip fractures   occurring in the total population.
  108. 111. Effect of Risedronate on the risk of hip fracture in elderly women McClung MR, Geusens P, Miller PD, Zippel H, Bensen WG, Roux C, et al. N Engl J Med  2001;344:333-40 <ul><li>The only adequately sized clinical trial assessing the efficacy of bisphosphonates on hip fracture among this older age group, found no significant effect. Additionally, the efficacy, expense, and adverse effects of osteoporosis drugs have not been examined in nursing homes, where many hip fractures occur. </li></ul>
  109. 112. Cochrane Review Alendronate & Risedronate women with low BMD + fragility fracture of Spine: Fracture of the spine       - 12 out of 100 women with placebo        - 6 out of 100 women with alendronate Fracture in the hip or wrist        - 2 out of 100 women with placebo        - 1 out of 100 women with alendronate Fractures in bones other than the spine         - 9 out of 100 women placebo         - 7 out of 100 women alendronate
  110. 113. women with normal BMD and no fragility fractures of their spine: Fracture of the spine                  - 3 out of 100 women with placebo                 - 1 out of 100 women with alendronate   Fractures in bones other than the spine:                  - 1 out of 100 women with placebo                  - 1 out of 100 women with alendronate                 - 3 out of 100 women with placebo                  - 4 out of 100 women with alendronate                    - 13 out of 100 women with placebo                  - 12 out of 100 women with alendronate
  111. 114. Cochrane review Risedronate <ul><li>Risedronate for preventing fractures by osteoporosis.  In women with low BMD with or without fracture: </li></ul><ul><li>probably prevents fractures in the bones of the spine and in bones other than in the spine; - may prevent hip fractures; - may not lead to any difference in wrist fractures . </li></ul>
  112. 115. Cochrane review….. <ul><li>In women with normal BMD and no fracture: may not lead to any difference in fractures in the bones of the spine, hip fractures or wrist fractures; there is not enough information to tell if Risedronate prevents fractures in bones other than in the spine. </li></ul>
  113. 116. What should you do? <ul><li>1. you should prescribe antiresorptive agents after the age of 65 &quot;just because&quot; the patient will develop osteoporosis. </li></ul><ul><li>2. you should prescribe antiresorptive agents after the age of 65 &quot;just because&quot; the patient has osteoporosis and might develop a 'fragility' fracture </li></ul><ul><li>3. you should prescribe antiresorptive agents after you have fixed a fragility fracture. </li></ul><ul><li>4. you should prescribe exercises, calcium of 1000 mg/day and Vit D at 700 iu/day for reducing the risk of fracture in elderly patients. </li></ul>
  114. 117. The NEW Interactive IOF One-Minute Osteoporosis Risk Test <ul><li>19 easy questions to help you understand the status of your bone health </li></ul>Your language: Your gender: Woman  ♀ Man  ♂
  115. 118. Few Simple ways <ul><li>If you are or consider your self Obese, </li></ul><ul><li>If you are exposed to Sun during your shopping in open markets at least twice a week, </li></ul><ul><li>If you take Milk and you are a vegetarian, </li></ul><ul><li>If you are taking regular Morning walk, </li></ul><ul><li>If you are regular about exercises (YOGA). </li></ul><ul><li>Your Death is not due to Fractures but due to age and co morbidity. </li></ul>You need not know about your T-score
  116. 119. Summary <ul><ul><li>Globalization of Diagnosis of Osteoporosis & Osteopenia, </li></ul></ul><ul><ul><li>BMD screening, </li></ul></ul><ul><ul><li>Redefining Risk factors & role of fall and BMD in fractures, </li></ul></ul><ul><ul><li>Cost effectiveness of drug treatment, </li></ul></ul><ul><ul><li>Hype about Hip fractures, </li></ul></ul><ul><ul><li>Role of Big Pharma in propaganda of diagnosis, management, corruption in scientific literature, misuse political system and creation a state of </li></ul></ul><ul><ul><li>“ Fear psychosis & Hope selling”. </li></ul></ul>There is an acute need for reconsidering
  117. 120. A lie told often enough becomes the truth.   Vladimir Lenin  
  118. 121. <ul><li>DISCLAIMER . </li></ul><ul><li>• It is intended for use only by the students of orthopaedic surgery. </li></ul><ul><li>Views and opinion expressed in this presentation are personal. </li></ul><ul><li>• For any confusion please contact the sole author for clarification. </li></ul><ul><li>Every body is allowed to copy or download and use the material best suited to him. I am not responsible for any controversies arise out of this </li></ul><ul><li>presentation. </li></ul><ul><li>IMPORTANT INFORMATION </li></ul><ul><li>All animation slides are taken from, “Osteoporosis and Bone Physiology” web site, 1999 - 2006 of Dr. Susan Marie Ott , MD. </li></ul><ul><li>Some details are taken from an article by Alix Spiegel - Related NPR Stories </li></ul><ul><li>Some of the photographs are taken from IOF web site . </li></ul><ul><li>Some of the photographs are taken from The New York Times and from article By Susan Kelleher · Seattle Times staff reporter </li></ul><ul><li>Some slides are from “ Wikipedia” . </li></ul><ul><li>Some slides are from teaching slides of British Medical Journal . </li></ul><ul><li>If there is any copy right violation, please notify immediately. </li></ul><ul><li>Most of the quotes used have their author’s name under it. For any omission please inform </li></ul>