1. Michael J. Econs, M.D. Professor of Medicine Indiana University School of Medicine Indianapolis, IN 46202 Update on Management of Osteoporosis

2. Faculty Disclosure It is the policy of the American Society for Bone and Mineral Research (ASBMR) and The France Foundation to ensure balance, independence, objectivity, and scientific rigor in all its sponsored educational activities. All faculty participating in this activity will disclose to the participants any significant financial interest or other relationship with manufacturer(s) of any commercial product(s)/device(s) and/or provider(s) of commercial services included in this educational activity. The intent of this disclosure is not to prevent a faculty member with a relevant financial or other relationship from participating in the activity, but rather to provide participants with information on which they can base their own judgments. The American Society for Bone and Mineral Research (ASBMR) and The France Foundation have identified and resolved any and all faculty conflicts of interest prior to the release of this activity. This activity is supported by an educational grant from Amgen Inc.

3. Learning Objectives Improve the ability to assess risk factors for osteoporosis and apply evidence-based screening recommendations to these at-risk patients within one’s practice Develop strategies to improve the treatment of patients with osteoporosis Utilize the tools and other information in this initiative, including patient education tools and systems-based approaches, to facilitate improving the assessment and care being provided to patients with osteoporosis

4. Agenda 20 minutesSlide lecture 20 minutesCase exercise in small groups 10 minutesDiscussion Resources for you to keep Pretest Case Worksheet Posttest Evaluation Tear off now to take home Please complete the quick pretest NOW For the small group exercise later Complete these when the activity is over When we’re done, leave on your seat or pass to staff Activity Packets Everyone should have a packet

5. Primary Care Providers Are Critical for Osteoporosis Management Screening, Diagnosis, and Treatment Osteoporosis is under-recognized Fractures are not recognized as sentinel events Osteoporosis is under-treated American Society for Bone and Mineral Research (ASBMR) and The France Foundation 2013 2014 2013 2014 Education for PCPs Live Meetings and Online CME (free) www.osteoCME.org

6. 2000 NIH Consensus Development Conference Definition of Osteoporosis Normal Bone Osteoporotic Bone A skeletal disorder characterized by – Compromised bone strength predisposing to – An increased risk of fracture Bone strength reflects the integration of two main features: – Bone density – Bone quality

7. Osteoporosis Is a Serious Public Health Problem Affects 10.2 million Americans (80% women) 2 million fractures yearly Direct cost $17 billion Distribution of Fractures

8. Osteoporosis in Perspective

9. Identified Treatment Gap NCQA HEDIS HEDIS Measure% Compliance* Beta-blocker persistence after a heart attack 88.5% Breast cancer screening67.5% Colorectal cancer screening58.4% Osteoporosis management for women after a fracture 25.0% NCQA The State of Health Care Quality 2013. https://www.ncqa.org/ReportCards/HealthPlans/StateofHealthCareQuality.aspx. Accessed August 2014. *2012 Medicare Rates

10. Patient Care Goals Identify patients at risk of fractures Reduce incidence of fractures Maintain quality of life – Activity – Independence – Health

11. National Osteoporosis Foundation 2014 Guidelines Universal (risk, diet, vitamin D, exercise, smoking, monitoring) Diagnosis (BMD, vertebral imaging, causes of secondary osteoporosis) Monitoring (BMD) Treatment (initiation criteria, options, duration) Major clinical recommendations http://www. http://nof.org/hcp/resources/913. Accessed August 2014.

12. 2014 Universal Recommendations http://www.nof.org/hcp/practice/tools. Accessed August 2014. Counsel on the risk of fractures Eat a diet rich in fruits and vegetables (supplemented if necessary) to a total calcium intake of 1000 mg per day for men 50-70 1200 mg per day for women ≥ 51 1200 mg per day for men ≥ 71 Vitamin D intake should be 800-1000 IU per day (age ≥50), supplemented if necessary Regular weight-bearing and muscle-strengthening exercise Fall prevention evaluation and training Cessation of tobacco use and avoidance of excessive alcohol intake

13. Who Should Have a Bone Density Test? AAFP and NOF AAFP: Sweet MG, et al. Am Fam Physician. 2009;79(3):193-200. NOF: National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. www.nof.org. Accessed August 2014. Women age 65 and older Men age 70 and older Postmenopausal women and men ages 50–69 with clinical risk factors Adults who have a fracture after age 50 Adults with a condition (e.g., rheumatoid arthritis) or taking a medication (e.g., glucocorticoids) associated with low bone mass or bone loss

14. WHO Criteria for Postmenopausal Osteoporosis The T-score compares an individual’s BMD with the mean value for young adults and expresses the difference as a standard deviation score CategoryT-score Normal-1.0 and above Low bone mass (osteopenia) -1.0 to -2.5 Osteoporosis-2.5 and below http://www.who.int/chp/topics/Osteoporosis.pdf. Accessed August 2014. WHO Study Group. World Health Organ Tech Rep Ser. 1994;843:1-129.

15. Web Version 3.4 http://www.shef.ac.uk/FRAX/. Accessed August 2014.

17. Benefits of FRAX Derives 10-year probability of clinical event from measurable parameters Internationally recognized and validated Based on data from multiple cohorts Easily accessible on the Internet or DXA software Helps identify patients who need treatment Can be used to reassure low-risk patients Not valid to monitor patients on treatment Only femoral neck BMD is considered Risk is “yes/no” – there is no consideration of “dose” (e.g., fractures, glucocorticoids, smoking, alcohol) Not all risk factors are included (eg, risk of falling) Clinical judgment is required Do patients with high FRAX scores benefit from medication? (Unknown) Limitations of FRAX Watts NB, et al. J Bone Miner Res 2009;24:975-979.

18. Whom to Treat: NOF Guidelines 2014 Women ≥ 65 and men ≥ 70 (younger with risk factors) T-score between -1.0 and -2.5 T-score ≤ -2.5 in the lumbar spine, total hip, or femoral neck or Hip or spine fracture (clinical or radiographic) DXA test ≥ 3% for hip fracture or ≥ 20% for major osteoporotic fractures FRAX 10-y fracture risk Candidate for TREATMENT YES nof.org/hcp/resources/913. Accessed August 2014.

19. FDA-approved Medications Osteoporosis  Post- menopausal Glucocorticoid- induced Male Drug PreventTreatPreventTreat Estrogen Calcitonin* (Miacalcin®, Fortical®) Raloxifene (Evista®) Ibandronate (Boniva®) Alendronate (Fosamax®) Risedronate (Actonel®) Risedronate (Atelvia®) Zoledronate (Reclast®) Denosumab (Prolia™) Teriparatide (Forteo®) Diab DL, Watts NB. Endocrinol Metab Clin North Am. 2013;42(2):305-317.

20. Drug Vertebral Fracture Nonvertebral Fracture Hip Fracture Calcitonin Raloxifene Ibandronate Alendronate Risedronate Zoledronic acid Denosumab Teriparatide Evidence for Fracture Reduction Diab DL, Watts NB. Endocrinol Metab Clin North Am. 2013;42(2):305-317.

21. Choosing an Antiresorptive Agent Efficacy “broad spectrum” antifracture efficacy (alendronate, risedronate, zoledronate, denosumab) Route of administration oral (fasting or with food) or parenteral Frequency of administration daily, weekly, monthly, quarterly, twice yearly, once yearly Side effects/tolerability depends on agent and patient Non-skeletal effectsbreast cancer reduction (raloxifene) Cost/insurance coverage generic oral; drugs “administered by health professional” covered by Medicare Part B

22. Factors That May Reduce Adherence EtiologyPossible Factors Patient-related Lack of understanding of condition or potential treatment benefits Patient motivation for treatment Comorbid conditions Cognitive dysfunction/forgetfulness No fracture history or symptoms Dissatisfactions with healthcare professional interaction Medication-related Cost Dosing regimen/frequency Side effects Safety misconceptions

23. Monitor treatment with DXA every 1–2 years – Do not "over-interpret" change – Be happy when BMD is stable OR increasing Why do some patients lose BMD on treatment? – Adherence – Drug pharmacokinetics – Underlying disorders that need to be addressed Patients on treatment whose BMD remains low are at high risk of fracture and may benefit from longer treatment Monitoring

24. Secondary Fracture Prevention A fracture is a sentinel event A fracture in a person over 50 is the most powerful risk factor for a future fracture Many high risk patients have their fractures successfully treated but do NOT receive assessment and treatment to prevent the next fracture Fracture Liaison Service (FLS) is an emerging model for secondary prevention

25. Fracture Liaison Services FLS coordinator orchestrates care following a minimal trauma fracture Several models in use internationally Positive impact – Increased BMD testing rates – Therapy initiation rates Insufficient data – Cost-effectiveness – Secondary fracture reduction Ganda K, et al. Osteoporos Int. 2013;24(2):393-406. Dehamchia-Rehailia N, et al. Osteoporos Int. 2014;25(10):2409-2416.

26. Management Rates After Fracture WomenMen DXA19.0%10.2% Treatment18.6%9.6% Retrospective cohort study 2000-2009 88,571 women; 41,984 men Management within 1 year of frailty fracture: Balasubramanian A, et al.J Bone Joint Surg Am. 2014;96(7):e52.

27. Treatment Rates Are Decreasing Patients Initiating Treatment Within 1 Year of Fracture (%) Balasubramanian A, et al.J Bone Joint Surg Am. 2014;96(7):e52. Year Women Men

28. Evaluation and Treatment for Osteoporosis: Not Just One Quick Visit Initial Evaluation Order DXA Assess Fx Risk If Fx Risk is Low, discuss calcium & Vit D, Stop for Now Reevaluate Later If Fx Risk is Borderline or High, Schedule Second Visit Second Visit Review DXA/Fx Risk Discuss Calcium and Vitamin D Order Labs if Needed Discuss Rx Options Schedule Third Visit Third Visit Review Labs, Act if Needed Select Rx Schedule Follow Up CBC Calcium, kidney tests, liver tests, and phosphorus 25-OH vitamin D 24 hour urine calcium Testosterone (in men) CBC Calcium, kidney tests, liver tests, and phosphorus 25-OH vitamin D 24 hour urine calcium Testosterone (in men)

29. Where Are We Now? Improved awareness Excellent diagnostic tools available FRAX is a quantitative risk assessment Safe and effective individualized treatment Better understanding of pathogenesis Federal initiatives to improve care The Good News Under-recognition of patients at risk for fracture Decreasing access to DXA Poor patient understanding of risk/benefit Increasing patient concerns about side effects Fewer patients on therapy Poor adherence 30% of patients don’t pick up new bisphosphonate prescriptions Risk of fracture increased 30–40% Ross S, et al. Value Health. 2011;14(4):571-581. Reynolds K, et al. Osteoporos Int. 2013; 24(9):2509-2517. The Bad News

30. What Can I Do as a PCP? Practical Steps Patient Dialog Risk/benefit discussion Shared decision making Patient Dialog Risk/benefit discussion Shared decision making Decision Aids Electronic records Checklist for risk Handouts/ Web sites Decision Aids Electronic records Checklist for risk Handouts/ Web sites Engage the Care Team Counseling, follow-up ID high-risk patients Engage the Care Team Counseling, follow-up ID high-risk patients Manage Nonadherence Identify individual barriers Address barriers Manage Nonadherence Identify individual barriers Address barriers

31. What is it? Developed by the Centers for Medicare & Medicaid Services (CMS) in 2007 as a voluntary reporting program that provides a financial incentive to physicians and other eligible professionals who report data on quality measures for covered services furnished to Medicare beneficiaries. What is the incentive/penalty schedule? If you participate in PQRS, you can receive an incentive payment of 0.5% of all your total allowed charges for Physician Fee Schedule (PFS) covered services. As of 2013, providers who do not successfully report PQRS measures will incur a 1.5% negative adjustment in their 2015 Medicare reimbursements; the negative adjustment will increase to 2% for each year thereafter. http://www.cms.gov/. Accessed August 2014. https://www.medconcert.com/content/medconcert/FractureQIR/ Physician Quality Reporting System (PQRS)

32. Quality Measures in Osteoporosis 2014 PQRS Claims Measures Measure Number DomainMeasure Title 24 Communication and Care Coordination Osteoporosis: Communication with the Physician Managing On-going Care Post Fracture of Hip, Spine, or Distal Radius for Men and Women Aged 50 Years and Older 39 Effective Clinical Care Screening or Therapy for Osteoporosis for Women Aged 65 Years and Older 40 Effective Clinical Care Osteoporosis: Management Following Fracture of Hip, Spine, or Distal Radius for Men and Women Aged 50 Years and Older 41 Effective Clinical Care Osteoporosis: Pharmacologic Therapy for Men and Women Aged 50 Years and Older http://www.cms.gov/. Accessed August 2014.

33. Summary What is osteoporosis? Decreased bone strength predisposing to an increased risk of fracture Why should you care? Common, significant cost, morbidity and mortality Whom to test and how? DXA for all women by age 65, higher risk women earlier; FRAX is a useful tool Whom to treat and how? Individuals at high risk of fracture; approved agents are safe and effective; treatment decisions must be individualized

34. Case Workshop: Small Group Exercise Everyone should have a packet We’re going to use the green sheet for this exercise. 1.I will present part of a case 2.Your small group will have 4 minutes to discuss it 3.After 4 minutes, I’ll present the next part of the case 4.You will have 4 minutes to discuss next steps 5.Finally, we will review the case for 10 minutes Resources for you to keep Pretest Case Worksheet Posttest Evaluation

35. Patient Presentation: “Emily” 73-year-old Caucasian woman Recent wrist fracture – fell in parking lot due to uneven surface Emily: Patient History 1 Medical −Hypertension −Menopause at age 48, treated with estrogen until age 61 −No prior fracture Family −No history of osteoporosis or fracture

36. Emily: Patient History 2 Social −Married −Tobacco: 20 pack year history; quit 1985 −Alcohol: 2 glasses of wine per week −Caffeine: Coffee and tea, each 2 cups per day −Calcium/Vitamin D: yogurt 1 serving/day, greens regularly −Exercise: none regularly Medications −Multivitamin daily containing 400 mg calcium and 400 IU vitamin D −Lisinopril: 10 mg daily

37. Other Data Review of systems −No prior falls, no balance issues −Nocturia 1-2 times per night −Otherwise all negative Physical Examination −Weight 117 pounds, Height 62”, BMI 21.4 −BP 120/74 −No significant findings. No dowager’s hump.

38. Please Break Into Work Groups With your neighbor, turn around and form a team of 4 with the two neighbors behind you If you are not matched up with a group, join a group that is closest to you Goal is groups of 3-4

39. 0 4 0 Minutes Seconds Emily Small Group Discussion # 1 Break into your groups Discuss your answers Record your answers on the green sheet (your answers help guide future education) Total time: 4 minutes 0 EMILY DISCUSSION # 1 What are Emily’s risk factors for future fracture? ______________________ What tests would you order? ______________________ ______________________

40. Further Patient Work-up DXA Results −Lumbar spine T-score: -1.8 −Left total hip T-score: -1.1; left femoral neck T-score: -1.9 −Left 1/3 radius T-score: -1.4 −VFA T4-L4: normal FRAX 10 year risk of fracture: major: 19%; hip: 4.0% Lab Results −CBC: normal −CMP and phosphorus: normal −25-OH vitamin D: 22.4 ng/mL −24-hour urine calcium: 142.5 mg −Creatinine: 0.76 mg/dL

41. Emily Small Group Discussion # 2 Turn to part two of your green sheet and discuss your next steps Record your answers on the green sheet (your answers help guide future education) Total time: 4 minutes EMILY DISCUSSION # 2 Is Emily a candidate for osteoporosis therapy? Why or why not?______________ __________________ If you need more information to make a recommendation, what is it? _____________

42. 0 4 0 Minutes Seconds 0 Emily Discussion Record Your Group Answers DXA Results −Lumbar spine T-score: -1.8 −Left total hip T-score: -1.1 −Left femoral neck T-score: -1.9 −Left 1/3 radius T-score: -1.4 −VFA T4-L4: normal FRAX 10 year risk of fracture −Major: 19% −Hip: 4.0% Lab Results −CBC: normal −CMP and phosphorus: normal −25-OH vitamin D: 22.4 ng/mL −24-hour urine calcium: normal

43. Group Review of Case Emily’s risk factors Age Low body weight Personal history of low-trauma/fragility fracture Sedentary lifestyle Low calcium and vitamin D intake Vitamin D insufficiency Evaluation for secondary causes Vitamin D insufficiency was discovered and addressed Calcium and vitamin D sufficiency are important for bone health

44. VFA Proactive vertebral imaging is important and helps in risk stratification A vertebral compression fracture would have made her a candidate for pharmacologic treatment regardless of bone density FRAX Helpful in risk stratification Uses a combination of clinical risk factors and BMD to predict fracture risk Emily is at high risk of fracture and exceeds the threshold for recommended treatment based on her FRAX risk and the NOF guidelines Case resolution Should discuss vitamin D repletion, calcium intake, weight bearing/strength exercises, fall risk reduction, etc Emily is certainly a candidate for pharmacologic treatment Group Review of Case

45. Online Tools and Resources www.osteoCME.org – Free online CME – PQRSwizard® FRAX Tool – www.shef.ac.uk/FRAX/ AAFP guidelines – Sweet MG, et al. Am Fam Physician. 2009;79(3):193-200. www.nof.org – Bone Health Basics – Patient resources, support – NOF Clinician’s Guide 2014 ACP treatment guidelines – Qaseem A, et al. Ann Intern Med. 2008;149(6):404-415. Fracture Liaison Services – NBHA resource center: www.nbha.org

46. Please Leave Blue And Green Handouts on your Chair or Hand to Meeting Staff at the Door or Registration Desk Please visit www.OsteoCME.org for more education Resources for you to keep Pretest Case Worksheet Posttest Evaluation Keep the white page (page 1)

47. For more education and resources please visit www.osteoCME.org Questions or Comments?