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  1. 1. Osteoporosis
  2. 2. Learning objectives : <ul><li>Burden of the disease. </li></ul><ul><li>Screening and treatment guidelines. </li></ul><ul><li>Bisphosphonates. </li></ul><ul><li>Controversial topics : Association of bisphosphonates with </li></ul><ul><ul><li>ONJ </li></ul></ul><ul><ul><li>Atypical femoral fractures </li></ul></ul><ul><ul><li>Atrial fibrillation. </li></ul></ul><ul><ul><li>Esophageal cancer. </li></ul></ul>
  3. 3. Burden of Disease <ul><li>10 million people in US have Osteoporosis </li></ul><ul><li>33 million people in US have Osteopenia. </li></ul><ul><li>Bone health and osteoporosis: Department of health & human services 2004. </li></ul>
  4. 4. Burden of Disease <ul><li>> 2 million fractures/year due to either. </li></ul><ul><ul><li>300,000 HIP fractures. </li></ul></ul><ul><ul><li>547,000 vertebral fractures. </li></ul></ul><ul><ul><li>135,000 pelvic factures. </li></ul></ul><ul><ul><li>Bone health and osteoporosis: Department of health & human services 2004. </li></ul></ul>
  5. 5. Burden of Disease : <ul><li>Hip fractures : </li></ul><ul><li>50 % Permanent impaired mobility. </li></ul><ul><li>25 % Loose skills to live independently. </li></ul><ul><li>Increased all cause mortality : first 3 months after hip fracture. </li></ul><ul><ul><li>1.2010 position statement of the North American Menopause Society. Menopause 2010. </li></ul></ul>
  6. 6. Annual incidence
  7. 7. Osteoporosis
  8. 8. Risk factors
  9. 9. Who to screen <ul><li>Women > 65 years. </li></ul><ul><li>Men > 70 years. </li></ul><ul><li>Postmenopausal women /men >50 years with clinical risk factors. </li></ul><ul><li>H/o fracture at age > 50 years. </li></ul><ul><li>Chronic steroid use. </li></ul>
  10. 11. Who to treat ? Prior h/o hip/vertebral # or T Score < -2.5 or T Score -1 to -2.5 & 10 yr risk (FRAX) : HIP # > 3 % or major osteoporotic # > 20 % Postmenopausal women /men > 50 yrs with
  11. 12. Calcium and vitamin D
  12. 13. Mainstay of treatment : <ul><li>Bisphosphonates </li></ul><ul><li>Approval in US for osteoporosis </li></ul><ul><li>Alendronate : 1995 </li></ul><ul><li>Risedronate : 2000 </li></ul><ul><li>Ibandronate : 2005 </li></ul><ul><li>Zoledronate : 2007. </li></ul>
  13. 14. Bone marrow precursors Osteoblasts Osteoclast Lining cells Stimulators of Bone Formation Fluoride PTH analogs Sr Ranelate (?) Inhibitors of Bone Resorption Estrogen, SERMs Bisphosphonates Calcitonin Inhibitors of RANKL Cathepsin K Therapeutic strategies
  14. 15. THE LANCET Vol 348 • December 7, 1996 Clinical Evidence
  15. 20. Taking Bisphosphonates
  16. 21. Contraindications
  17. 22. Duration of treatment
  18. 23. Cost factor <ul><li>Alendronate: $4 - $40/month </li></ul><ul><li>Risedronate : $60 - $120/month </li></ul><ul><li>Ibandronate (oral): $90 - $130/month </li></ul><ul><li>IV Ibandronate : $1300/year </li></ul><ul><li>IV Zoledronate : $1300/year </li></ul>
  19. 24. Hot topics
  20. 25. Osteonecrosis of jaw
  21. 26. ONJ <ul><li>Osteoporosis : </li></ul><ul><ul><li>Reporting rate 1/100,000 - 1/250.000. </li></ul></ul><ul><ul><li>True incidence may be higher. </li></ul></ul><ul><li>Malignancy/skeletal metastasis : </li></ul><ul><ul><li>Estd. Incidence: btw 1- 10 % </li></ul></ul>
  22. 27. Risk factors
  23. 28. Recommendations
  24. 29. Atypical fractures
  25. 30. Atypical fractures <ul><li>? Long term over suppression of bone turnover. </li></ul><ul><li>Incidence : 1 in 10,000. </li></ul><ul><li>Associated median treatment duration : 7 years. </li></ul><ul><li>Causality : long term bp/ atypical # unproven. </li></ul><ul><li>Further large scale studies needed. </li></ul>
  26. 31. Recommendations <ul><li>Educate physician/patient about Prodromal pain. </li></ul><ul><li>Evaluate with urgent X-Ray. </li></ul><ul><li>If negative, may consider MRI. </li></ul><ul><li>Stop BP’s if atypical fracture confirmed. </li></ul><ul><li> Shane et al. ASBMR task report. J Bone Miner Res. 2010 </li></ul>
  27. 32. Atrial fibrillation <ul><li>FDA recommends physicians to not alter their prescribing patterns while it continues to monitor post marketing reports of AF in such patients. </li></ul><ul><li>In v/o above and absence of definitive data : Benefits of treatment outweigh risks. </li></ul>
  28. 33. Esophageal cancer <ul><li>23 cases reported in last 2 decades. (Wysowski et al) </li></ul><ul><li>31 cases from Europe/Japan. </li></ul><ul><li>Median time from use to diagnosis : 1-2 yr. </li></ul><ul><li>Time from exposure inconsistent w/ causal relation. </li></ul><ul><li>Further studies needed. </li></ul>
  29. 34. Renal safety <ul><li>Safe for creatinine clearance > 30 -35 ml/min. </li></ul><ul><li>Lack of experience < 30 ml/min. </li></ul><ul><li>No data for use in ESRD. </li></ul><ul><li>Exact bone disease unknown unless biopsy. </li></ul><ul><li>Expert opinion: half the dose could be used for 3 years in ESRD once bone biopsy confirms osteoporosis. </li></ul>
  30. 35. Take home points <ul><li>Osteoporosis : significant burden of disease. </li></ul><ul><li>Main stay treatment : bisphosphonates. </li></ul><ul><li>? Duration of treatment : individualized. </li></ul><ul><li>More research needed to confirm association with ONJ, Subtrochanteric fracture. </li></ul><ul><li>Benefits of treatment outweigh risks in osteoporosis. </li></ul>