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Hyatt Regency Dearborn Dearborn, Michigan May 17, 2008

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  1. Hyatt Regency DearbornDearborn, MichiganMay 17, 2008 2008 Symposia Series 2 1

  2. Osteoporosis Update: Prevention, Diagnosis, and Treatment Lawrence M. Herman, MPA, PA-C Senior Clinical Coordinator/Assistant Professor New York Institute of Technology New York College of Osteopathic Medicine Old Westbury, New York

  3. Faculty Disclosure • Mr Herman has no relevant financial relationships with any commercial interests to disclose

  4. 0 How confident are you addressing modifiable risk factors for osteoporosis with your patients? • Very confident • Somewhat confident • Not at all confident Use your keypad to vote now!

  5. Learning Objectives • Assess the risk factors associated with osteoporosis • Manage osteoporosis in the context of comorbidities • Evaluate nonpharmacologic preventive approaches as well as the efficacy and safety of pharmacologic management

  6. Osteoporosis Defined • Osteoporosis, primary or secondary, is characterized by compromised bone strength predisposing to an increased risk of fracture • Osteoporosis = bone mineral density (BMD) ≤2.5 SD below young normal mean at hip or spine [WHO] Bone density=grams of mineral/area, volume Bone quality=architecture, turnover, damage accumulation, mineralization Bone strength = density + quality SD = standard deviation; WHO = World Health Organization. National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Available at: www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 22, 2008; NIH Consensus Statement. 2000;17:1-45

  7. Prevalence of Osteoporosis* *Estimates based on 2000 census data. Ebeling PR. N Engl J Med. 2008;358:1474-1482; National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Available at: www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 22, 2008. • Osteoporosis is a major health threat in the United States • 10 million Americans have osteoporosis, 34 million are at risk • Osteoporosis disproportionately affects Caucasian and Asian women; other races/ethnicities are also significantly affected • Under-recognized problem in men • In men, involvement of all races and ethnicities is significant • In the United States, women and men aged ≥50 years • 55% have low bone mass • 8 million women and 2 million men have osteoporosis • 1 of 2 white women, 1 of 5 men will suffer an osteoporosis-related fracture • African Americans with osteoporosis have same fracture risk as white persons

  8. 0 Which of the following best characterizes the burden of osteoporosis? • Osteoporotic fractures are more common than MI, stroke, and breast cancer combined • Only MIs are more prevalent than osteoporotic fractures • Incidence of osteoporotic fractures is equal to that of MIs • None of the above Use your keypad to vote now! MI = myocardial infarction.

  9. 2,000,000 1,500,000* 1,500,000 250,000hip 250,000forearm Annual incidence of Common Diseases 1,000,000 250,000 other sites 513,000† 500,000 228,000** 750,000 vertebral 184,300 0 Osteoporotic MI Stroke Breast Cancer Fractures Osteoporotic Fractures Are More Common Than MI, Stroke, and Breast Cancer Combined *Annual incidence all ages; †annual estimate women 29+; **annual estimate women 30+. American Cancer Society. Cancer Facts and Figures: 2003. Available at: www.cancer.org/downloads/STT/CAFF2003PWSecured.pdf. Accessed April 15, 2008; American Heart Association. Heart and Stroke Statistics: 2003 Update. Available at: www.americanheart.org/downloadable/heart/10590179711482003HDSStatsBookREV7-03.pdf. Accessed April 15, 2008; Riggs BL, Melton LJ III. Bone. 1995;17(5 Suppl):505S-511S.

  10. 0 Which of the following is a common causeof secondary osteoporosis? • Proton pump inhibitors (PPIs) • Treatment for ulcerative colitis • Glucocorticoids • TNF-α receptor blockers and IL-1 receptor antagonists for the treatment of rheumatoid arthritis Use your keypad to vote now!

  11. Factors Contributing to Secondary Osteoporosis CHF = congestive heart failure; ESRD = end-stage renal disease; GI = gastrointestinal; MS = multiple sclerosis. AACE Osteoporosis Task Force. Endocr Prac. 2001;7:293-312; National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Available at: www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 30, 2008.

  12. Glucocorticoid Use and Fracture Risk 6 All nonvertebral 5.18 Forearm 5 Hip Vertebral 4 Relative Risk of Fracture Compared With Control 3 2.59 2.27 1.77 2 1.64 1.55 1.36 1.19 1.17 1.1 1.04 0.99 1 0 n = 2192 531 236 191 2486 526 494 440 1665 273 328 400 Low Dose Medium Dose High Dose (<2.5 mg/d) (2.5-7.5 mg/d) (>7.5 mg/d) Van Staa TP, et al. J Bone Miner Res. 2000;15:993-1000.

  13. Mineralization Osteoid Pathophysiology of Osteoporosis Bone Remodeling Activation Resting Resorption Osteoclasts Bone Bone Reversal Formation Osteoblasts Bone Bone

  14. Changes in Trabecular Architecture • Decrease in trabecular thickness, more pronounced for non load-bearing horizontal trabeculae • Decrease in connections between horizontal trabeculae • Decrease in trabecular strength and increased susceptibility to fracture 20 years 50 years 80 years Mosekilde L. Calcified Tissue Inter. 1993;53(Suppl 1):S121-S126.

  15. Location of Corticaland Trabecular Bone Trabecular Bone 20% of skeletal mass 80% of bone turnover Thoracic andLumbar Spine 75% trabecular25% cortical Distal Radius 25% trabecular75% cortical Cortical Bone 80% of skeletal mass 20% of bone turnover Femoral Neck 25% trabecular75% cortical Hip: Intertrochanteric Region 50% trabecular50% cortical Favus MJ, ed. Primer on the Metabolic Bone Disease and Disorders of the Mineral Metabolism. 4th ed. Philadelphia, Pa: Lippincott Williams and Wilkins; 1999:30-32.

  16. Fracture Patterns By Age Vertebrae 4000 3000 Hip Annual Fracture Incidence /100,000 2000 1000 Colles' 0 35 45 55 65 75 85+ Age (years) Riggs B. N Engl J Med 1986;314:1676.

  17. Behaviorial/Lifestyle Measures to Prevent Osteoporosis • Adequate intake of dietary calcium, vitamin D, and protein throughout life • Regular physical activity; load-bearing exercise • Moderate alcohol intake • Stop smoking • Take measures to prevent falls • Use of hip protectors by patients prone to falling Ebeling PR. N Engl J Med. 2008;358:1474-1482; National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Available at: www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 22, 2008.

  18. 0 Which of the following is true with regard to vitamin D and bone health? • Oral vitamin D reduces the risk of hip fractures by 26% • Oral vitamin D has no benefit in preventing falls in osteoporotic patients • Only vitamin D absorbed through the skin is effective in preventing osteoporosis • Vitamin D supplementation has no effect on nonvertebral fractures • nonvertebral fractures Use your keypad to vote now!

  19. Vitamin D Protects Against Osteoporosis • Oral vitamin D supplementation 700-800 IU/d reduces risk of • Hip fracture by 26% • Nonvertebral fracture by 23% • Falls by 22% (↑ muscle strength, better balance) • Optimal fracture prevention achieved with 25-hydroxyvitamin D mean serum level 100 nmol/L • Best sources • Milk, salmon, canned tuna, sardines, eggs, liver, sunlight Bischoff-Ferrari HA , et al. JAMA. 2005;293:2257-2264.

  20. National Osteoporosis Foundation Clinical Recommendations 2008 • National Osteoporosis Foundation Clinical Recommendations February 2008 are based on the newly developed WHO 10-year fracture risk model (FRAX®) adapted to different population groups • The FRAX algorithm • Estimates the likelihood of a person breaking a bone due to osteoporosis during the next 10 years • Provides a useful way to ensure that people at risk of fracture receive treatment • Takes into account 9 clinical risk factors in addition to bone mineral density • Available online at http://www.shef.ac.uk/FRAX National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Available at: www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 22, 2008.

  21. Risk Factors Used to Calculate WHO 10-Year Fracture Risk *1 unit = 8 g alcohol ~ ½ pt beer ~ 1 glass wine. BMI = body mass index. Kanis JA, et al. Bone. 2002;30:251-258; Kanis JA, et al. Osteoporos Int. 2005;16:581-589; National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Available at: www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 22, 2008. Femoral neck T-score Age Sex Secondary osteoporosis Previous low-trauma fracture Low BMI Steroid exposure Family history of hip fracture Current cigarette smoking Alcohol intake >2 units/day* 21

  22. 10-Year Fracture Risk: Age and BMD • For a given BMD, risk increases with age Age 20 80 15 70 Hip Fracture Risk (% /10 Years) 10 60 5 50 0 -3 -2.5 -2 -1.5 -1 -0.5 0 0.5 1 BMD T-Score Kanis JA, et al. Osteoporos Int. 2001;12:989-995.

  23. Clinical Evaluation of Risk Factors for Osteoporosis • Medical history • Risk factors • Signs and symptoms • Physical examination • Height assessment (with stadiometer) • BMD testing • Laboratory tests

  24. Central Dual Energy X-Ray Absorptiometry (DEXA): Test of Choice for Diagnosing Osteoporosis • Benefits • Highly accurate and precise • Profiles all skeletal areas • Requires little time • Emits low dose of radiation • Limitations • AP spine measurement affected by vascular calcifications and spinal osteoarthritis • Trabecular and cortical bone measured together • AP = anteroposterior.

  25. T-Score • Number of SDs above or below sex-matched mean reference value of young adults • T-score = (BMD patient – BMD young normal reference) SD young normal reference • Comparison to peak bone mass • Peak adult bone mass follows a normal distribution (bell curve). Low bone mass on initial DEXA does not necessarily mean bone loss. Person may be at low end of bell curve • Used for adult diagnosis • Each SD decrease = doubling of fracture risk NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Treatment. JAMA. 2000;285:785-795.

  26. 0 Which of the following applies to the WHO/NOF criteria for diagnosis of osteoporosis? • T-score > -1.0 • T-score between -1 and -2.3 • T-score is not a WHO/NOF criterion for diagnosing osteoporosis • T-score ≤ -2.5 Use your keypad to vote now!

  27. WHO/NOF Criteria for Diagnosis of Bone Status *Measured in T-scores. T-score indicates the number of standard deviations below or above the average peak bone mass in young adults. Ebeling PR. N Engl J Med. 2008;358:1474-1482; National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Available at: www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 22, 2008.

  28. Fracture Rates Correlate With T-Scores: National Osteoporosis Risk Assessment (NORA) Study Data From More Than 163,000 Women Fracture Rate/100 Person-Years Siris ES, et al. JAMA. 2001;286:2815-2822. 28

  29. Risk Factors Used to Calculate WHO 10-Year Fracture Risk Low BMI Steroid exposure Family history of hip fracture Current cigarette smoking Alcohol intake >2 units/day* • Femoral neck T-score • Age • Sex • Secondary osteoporosis • Previous low-trauma fracture *1 unit = 8 g alcohol ~ ½ pt beer ~ 1 glass wine. BMI = body mass index. Kanis JA, et al. Bone. 2002;30:251-258; Kanis JA, et al. Osteoporos Int. 2005;16:581-589; National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Available at: www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 22, 2008.

  30. National Osteoporosis Foundation:Treatment Recommendations • Postmenopausal women and men aged >50 years with either of the following • Low bone mass (T-score -1 to -2.5, osteopenia) at femoral neck, total hip, or spine and 10-year hip fracture risk >3% • 10-year all major osteoporosis-related fracture risk >20% based on US-adapted WHO FRAX model National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Available at: www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 22, 2008.

  31. ACR Recommendations: Bisphosphonate Use in GIO • Prevention of bone loss in patients initiating long-term (3 months) glucocorticoid therapy • Patients with low BMD (T-score ≤1) receiving long-term glucocorticoid therapy • Patients receiving long-term glucocorticoid therapy who cannot tolerate HRT or had fractures during HRT ACR = American College of Rheumatology; GIO = glucocorticoid-induced osteoporosis; HRT = hormone replacement therapy. American College of Rheumatology Ad Hoc Committee on Glucocorticoid-Induced Osteoporosis.Arthritis Rheum. 2001;44:1496-1503.

  32. 0 Randomized, controlled trials with the bisphosphonate alendronate demonstrated reductions in risk of hip fracture at month 18 by: • <10% • 15%-25% • 30%-40% • >60% Use your keypad to vote now!

  33. Effects of Alendronate on Cumulative Incidence of Symptomatic Vertebral and Hip Fractures (FIT 1 and 2 Trials) Vertebral Hip 3 5 -59% -63% 4 PBO PBO 2 P <.014 3 P <.001 Cumulative Incidence Cumulative Incidence ALN 2 ALN 1 * * * * * * 1 * * * 0 0 0 6 12 18 24 30 36 0 6 12 18 24 30 36 Months Months *P <.05 ALN = alendronate; FIT = Fracture Intervention Trial; PBO = placebo. Black DM, et al. J Clin Endocrinol Metab. 2000;85:4118-4124. 33

  34. Risedronate Reduces Risk of VertebralFracture in High-Risk Subjects in 1 Year Placebo 68% (51%, 80%) P <.001 Risedronate 5 mg 60% (33%, 77%) P <.001 14 62% (36%, 77%) P <.001 12 62% (44%, 75%) P <.001 10 48% (7%, 71%) P = .029 8 Percent of Subjects With New Vertebral Fractures 6 4 2 0 Aged 70 Years 2 Prevalent Fractures Low FN BMD Low LS BMD Overall FN = femoral neck; LS = lumbar spine. Watts NB, et al. J Clin Endocrinol Metab. 2003;88:542-549.

  35. Women’s Health Initiative: Effects of HRT in Women Aged 50-79 6700 Women With 5.2 Years of Follow-up Disadvantages Vertebral fracture Intestinal cancer Hip fracture Difference (%) vs Placebo Stroke Cardiovasculardiseases Breast cancer Thromb. venous Advantages Manson JE, at al. N Engl J Med. 2003;349:523-534. 37

  36. MORE: Increase in BMD With Long-term Raloxifene Treatment BMD Lumbar Spine BMD Femoral Neck Placebo (n = 1512) Raloxifene 60 mg (n = 1490) 3 3 2 2 1 1 Mean % Change From Baseline 0 0 -1 -1 -2 -2 0 12 24 36 0 12 24 36 Months Months P <.001 for all comparisons. MORE = Multiple Outcomes of Raloxifene Evaluation. Ettinger B, et al. JAMA. 1999;282:637-645. 38

  37. MORE: Reduction in New Vertebral Fractures Among Women Who Completed the Study Placebo Raloxifene hydrochloride 60 mg/d Raloxifene hydrochloride 120 mg/d 25 RR 0.5 (95% CI, 0.4-0.6) RR 0.5 (95% CI, 0.6-0.9) 20 % of Patients With Incident Vertebral Fracture 15 10 5 0 N = 6828 RR = relative risk. Ettinger B, et al. JAMA. 1999;282:637-645. 39

  38. Calcitonin Nasal Spray: PROOF Study (Analysis at 5 Years) Reduction in % of New Vertebral Fractures vs Placebo No. of Hip Fractures Per Group 25 0 10 20 20 100 IU 18% (NS) 30 400 IU 23% (NS) 15 40 200 IU 33% (P = .03) 50 7 (NS) 10 8 60 4 (NS) 70 2 (NS) 5 80 90 0 100 Placebo 100 IU 200 IU 400 IU N = 511 NS = nonsignificant IU = international units; PROOF = Prevent Recurrence of Osteoporotic Fractures. Chesnut CH III, et al. Am J Med. 2000;109:267-276. 40

  39. Summary: FDA-Approved Osteoporosis Therapies PMO = postmenopausal. National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Available at: www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 22, 2008. 42

  40. 0 What percent of patients will stop their medications within 6-12 months of initiation? • <10% • 10%-15% • 20%-30% • 40%-50% Use your keypad to vote now!

  41. Adherence and Persistence • 20%-30% of patients taking oral osteoporosis medications suspend their medications within 6-12 months of initiation due to • Side effects • Lack of knowledge • Reluctance to take regular medications Papaioannou A. Drugs Aging. 2007;24:37-55.

  42. Osteonecrosis of Jaw • Osteonecrosis of jaw • Potential complication of bisphosphonate • Rare • 60% occur after dental extraction • Most cases occur in cancer patients • Most cases associated with high-dose IV bisphosphonate treatment in metastatic cancer patients

  43. Case Study

  44. Postmenopausal Asian Woman With Possible Osteoporosis • At annual physical examination for 57-year-old Asian woman • Height: 5 ft 2 in; weight: 101 lb; BMI: 18.5 kg/m2 • Postmenopausal for 5 years • No HRT • Medications: mesalamine for ulcerative colitis • No known drug allergies • Family history: mother had a hip fracture at age 76 years

  45. Postmenopausal Asian Woman With Possible Osteoporosis • Medical history: GERD, used PPIs daily for 5 years; ulcerative colitis, uses mesalamine; has used systemic steroids orally 3 or 4 times for limited periods of time • Diet: balanced, except does not include dairy (lactose intolerant) • Exercise: walks 20 minutes a day • Smokes ½ pack a day GERD = gastroesophageal reflux disease.

  46. 0 Should this patient have a DEXA scan? • No, she is <65 years of age • Yes, she is 5 years postmenopausal • Yes, she has multiple risk factors for osteoporosis Use your keypad to vote now!

  47. Moderate (RR 1-2) Major (RR ≥2) Risk Factors for Osteoporotic Fracture • Aged >70 years • Menopause aged <45 years • Hypogonadism • Fragility fracture • Hip fracture in parents • Glucocorticoids • Malabsorption • High bone turnover • Anorexia nervosa • BMI <18 kg/m2 • Immobilization • Chronic renal failure • Transplantation • Estrogen deficiency • Calcium intake <500 mg/d • Primary hyperparathyroidism • Rheumatoid arthritis • Ankylosing spondylitis • Anticonvulsants • Hyperthyroidism • Diabetes mellitus • Smoking • Alcohol in excess Brown JP, et al. CMAJ. 2002;167(10 suppl):S1-S34.

  48. 0 DEXA scan indicates T-score -1.9 lumbar spine; T-score -.9 femoral neck. Does this patient have osteoporosis? • Yes • No • Not enough information Use your keypad to vote now!

  49. WHO/NOF Criteria for Classification of Bone Status Diagnostic criteria* • T-score > -1 • T-score between -1 and -2.5 • T-score ≤ -2.5 • T-score ≤ -2.5 + fragility fracture(s) Classification • Normal • Osteopenia • Osteoporosis • Severe or established osteoporosis *T-score = number of standard deviations below or above the average peak bone mass in young adults. National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Available at: www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 22, 2008.

  50. 0 What treatment should be recommended for this patient? • Ca+ 1200-1500 mg/d • Ca+ 1200-1500 mg/d + 800 IU vitamin D • All of the above plus smoking cessation and consider adding a bisphosphonate Use your keypad to vote now!