1. 1 Osteoporosis Treatment in Frail Populations: A Framework for Decision- Making Cathleen Colón-Emeric, MD, MHSc Durham VA GRECC and Duke University Medical Center

2. 2 Objectives 1. Evidence for treating frail older adults 2. Why older adults are not getting treated 3. Deciding when and how to treat frail older adults: a framework for decision making

3. 3 Would you treat this patient? 70 yr old male with EF 25%, mild dementia, T score hip -2.6 If he was 80 years old? If he was 80 years old? If he had a prior fracture? If he had a prior fracture? If he lived in a nursing home? If he lived in a nursing home? If he was 90 years old? If he was 90 years old? If he had just broken a hip? If he had just broken a hip?

4. 4 Does Fracture Risk Warrant Treatment?

5. 5 FRAX to Estimate Fracture Risk http://www.shef.ac.uk/FRAX/

6. 6 Does Fracture Risk Warrant Treatment? Condition Fracture Risk Low BMD Double for each SD decrease NH Residence RR up to 10 1/10 white women/yr Prior Fracture RR 2-3.5 Parkinson’s Disease RR 2.5 Prostate Cancer RR 2-4 Stroke RR 2.5

7. 7 Bone Density Screening Recommendations for Older Veterans All women over age 65 VA recommendations: http://www.hsrd.research.va.gov/publications/esp/Osteoporsis-2007.pdf Osteoporosis Screening Test (OST): [Age(yrs) – Weight (kg)]*0.2, score <2 are predictive of low BMD Risk factor guided decisions: corticosteroids, prostate cancer, weight loss, physical inactivity, spinal cord injury ACP recommendations: Risk factor guided decisions: age, low body weight, weight loss, physical inactivity, corticosteroids, and previous fragility fracture

8. 8 Is treatment safe and effective in older patients? Bisphosphonates, Teriparatide, Raloxifene Bisphosphonates, Teriparatide, Raloxifene No change in Relative Risk Reduction No change in Relative Risk Reduction Increase in Absolute Risk Reduction Increase in Absolute Risk Reduction Hochberg, JBMR 2005;20:971-6; Boonen, JAGS 2006;54:782-9; Bonnen, JAGS 2004;52:1832-9; Boonen, JAGS 2010

9. 9 Is therapy cost effective in older patients? Most models assume 5 years BP treatment Most models assume 5 years BP treatment Estimates vary with model assumptions Estimates vary with model assumptions BUT, nearly all show increasing cost- effectiveness with advancing age BUT, nearly all show increasing cost- effectiveness with advancing age PTH Cost-effectiveness stable with age PTH Cost-effectiveness stable with age Schousboe, JAGS 2005;53:1607-1704; Lundquivst, Osteoporos Int 2006;17:1459-71

10. 10 Cost Effectiveness with Lower Life Expectancy Van Staa, Rheum 2007;46:460-6

11. 11 What is the lag time before treatment benefit?

12. 12 Objective 1 Summary 1. Evidence for treating frail older adults Higher risk for fracture Higher risk for fracture Treatments appear to be equally safe, and have greater absolute fracture reduction Treatments appear to be equally safe, and have greater absolute fracture reduction Cost effectiveness increases with age Cost effectiveness increases with age Rapid onset of effectiveness Rapid onset of effectiveness 2. Why are older adults not getting treated?

13. 13 Older Patients are Rarely Treated for Osteoporosis After a hip fracture After a hip fracture Fewer than 10% receive osteoporosis evaluation Fewer than 10% receive osteoporosis evaluation Fewer than 20% receive osteoporosis treatment Fewer than 20% receive osteoporosis treatment U.S., Canada, Europe, Academic Centers, Community Practices, VA Medical Centers U.S., Canada, Europe, Academic Centers, Community Practices, VA Medical Centers Wide variation in practice, 0-85% Wide variation in practice, 0-85% Gupta, J Am Med Dir Assoc 2003; Jachna, JAGS, 2005; Colon-Emeric, Osteoporos Int 2006

14. 14 VISN-6 Osteoporosis Treatment 2006-8 Barnard, Colon-Emeric, 2008

15. 15 Why are Older Patients Not Treated? Osteoporosis Rx System Factors Provider Factors Patient Factors

16. 16 Provider Factors Knowledge Knowledge Clinical Practice Guidelines Clinical Practice Guidelines Attitudes: Provider Survey Attitudes: Provider Survey Safe and effective, even in NH residents Safe and effective, even in NH residents “Not as important” as competing co-morbidities “Not as important” as competing co-morbidities Not cost effective Not cost effective Too many side effects Too many side effects Beliefs: “Not my role” Beliefs: “Not my role” Orthopedic surgeons vs. PCPs Orthopedic surgeons vs. PCPs Colon-Emeric, J Am Med Dir Assoc 2006; Skedros, JBMR 2006; Dreinhoffer, Osteop Int 2005

17. 17 Patient Factors Knowledge/Attitudes/Beliefs Knowledge/Attitudes/Beliefs Inadequate information Inadequate information “Women’s” disease “Women’s” disease “I’ve never broken a bone” “I’ve never broken a bone” Concern about side effects especially ONJ Concern about side effects especially ONJ Co-morbidities Co-morbidities Nursing Home Residents Nursing Home Residents Life expectancy Life expectancy Ribheiro et al. Health Care for Women Int, 2000

18. 18 Common Co-Morbidities Parkinson’s Disease Parkinson’s Disease BPs Increase BMD, may decrease hip fracture BPs Increase BMD, may decrease hip fracture Renal Insufficiency Renal Insufficiency BPs have similar efficacy, safe at GFR 30-45 ml/min BPs have similar efficacy, safe at GFR 30-45 ml/min Diabetes Diabetes BPs similar BMD and bone markers change BPs similar BMD and bone markers change Atrial Fibrillation Atrial Fibrillation Zoledronic acid increased serious events in younger women, but no increased risk in older hip fx patients Zoledronic acid increased serious events in younger women, but no increased risk in older hip fx patients Sato, Neurology 2007;68:911-15; Jamal, JBMR 2007;22:503-8; Keegan, Diabetes Care 2004;27:1547-53; Black, NEJM 2007; Lyles, NEJM 2007

19. 19 Nursing Home Residents Alendronate has similar effect on BMD and no increased side effects Alendronate has similar effect on BMD and no increased side effects Raloxifene has similar effect on markers of bone turnover Raloxifene has similar effect on markers of bone turnover Zoledronic acid after hip fracture, no interaction by NH residence Zoledronic acid after hip fracture, no interaction by NH residence Greenspan, 2002 Ann Int Med;136:742-6 ; Hansdotter, 2004 JAGS 52:779-83; Lyles, 2007 NEJM 357:1799-809.

20. 20 System Factors Multiple “silos” providing uncoordinated care Multiple “silos” providing uncoordinated care DXA availability for frail patients DXA availability for frail patients Formularies, Prior Authorizations Formularies, Prior Authorizations Availability of Infusion Services Availability of Infusion Services Financial disincentives for community nursing homes Financial disincentives for community nursing homes

21. 21 Objective 2 Summary 2. Why older adults are not getting treated Patient issues Patient issues Provider issues Provider issues System issues System issues 3. Deciding when and how to treat frail older adults: a framework for decision making

22. 22 Is Osteoporosis Treatment Worthwhile for this patient? Consider Consider Life expectancy Life expectancy Risk of fracture in remaining years of life Risk of fracture in remaining years of life Drug Efficacy Drug Efficacy Patient preferences Patient preferences Safety Safety Cost Cost

23. 23 Risk of Fracture in Remaining Life Years Concept from Walther et al. JAMA 2000; Data from U.S. Life Tables and NHANES, calculated by Colon-Emeric, 2008

24. 24 Risk of Fracture in Remaining Life Years Risk (%) of Fracture in Remaining Life Remaining Life Years, Women, by health quartile Remaining Life Years, Men, by health quartile Sickest Quartile

25. 25 Risk of Fracture in Remaining Life Years Risk (%) of Fracture in Remaining Life Remaining Life Years, Women, by health quartile Remaining Life Years, Men, by health quartile Healthiest quartile

26. 26 Risk of Fracture in Remaining Life Years Risk (%) of Fracture in Remaining Life Remaining Life Years, Men, by health quartile Remaining Life Years, Women, by health quartile

27. 27 Drug Efficacy: NNT with Oral Bisphosphonate Calculated from publicly available data, Colon-Emeric 2008

28. 28 Drug Efficacy: Choosing Between Classes

29. 29 Patient Preferences and Safety Delivery route Delivery route Frequency Frequency Pill size Pill size Compliance Compliance Cost Cost

30. 30 Other Conditions that Influence Choice of Therapy Gastritis, ulcer disease, dysphagia (oral BPs) Gastritis, ulcer disease, dysphagia (oral BPs) Prior DVT, recent fracture (raloxifene) Prior DVT, recent fracture (raloxifene) Hypercalcemia (PTH) Hypercalcemia (PTH) Prior cancer or radiation (PTH) Prior cancer or radiation (PTH) Upcoming major dental procedures (BPs) Upcoming major dental procedures (BPs) Cognitive, mobility impairment (oral BPs) Cognitive, mobility impairment (oral BPs) Number of Medications (monthly or yearly) Number of Medications (monthly or yearly)

31. 31 Practical Considerations Addressing Vitamin D deficiency Addressing Vitamin D deficiency Prevalence 12-70% Prevalence 12-70% Measurement vs. universal repletion Measurement vs. universal repletion Need for DXA Need for DXA Often not feasible Often not feasible Not necessary to start treatment after fracture Not necessary to start treatment after fracture Only if it will influence my treatment decisions Only if it will influence my treatment decisions

32. 32 Interventions that Improve Osteoporosis Care Hospital patient interview and 6-month phone call Hospital patient interview and 6-month phone call Doubled osteoporosis management by PCP 1 Doubled osteoporosis management by PCP 1 Faxed clinician reminders Faxed clinician reminders 3-Fold increase in testing and treatment 3 3-Fold increase in testing and treatment 3 Guidelines to PCPs and educational materials to patients Guidelines to PCPs and educational materials to patients Increased BMD testing and discussion with MDs 4 Increased BMD testing and discussion with MDs 4 Audits of performance Audits of performance Improved post-fracture osteoporosis testing to 80% 5 Improved post-fracture osteoporosis testing to 80% 5 1.Gardner MJ et al. J Bone Joint Surg Am. 2005;87:3-7. ; Solomon DH et al. Mayo Clin Proc. 2005;80:194- 202; Majumdar SR et al. Ann Intern Med. 2004;141:366-373; Cuddihy MT et al. Osteoporos Int. 2004;15:695-700.

33. 33 Osteoporosis Order Entry Algorithms

34. 34 Provider Education

35. 35 Objective 3 Summary 3. Deciding when and how to treat frail 3. Deciding when and how to treat frail older adults older adults Most co-morbidities are not contraindications to treatment Most co-morbidities are not contraindications to treatment In patients at high risk for fracture with at least 2 years of remaining life expectancy, consider pharmacologic therapy In patients at high risk for fracture with at least 2 years of remaining life expectancy, consider pharmacologic therapy Patient preferences and co-morbidities influence choice Patient preferences and co-morbidities influence choice Systems Interventions to improve care are needed Systems Interventions to improve care are needed

36. 36 Would you treat this patient? Remaining life (yrs) Major/Hip Fracture Risk (yrs) NNT 1 additional major Fx 70 yr old 6.711/4.226 80 yr old 3.312/5.824 Prior fx or NH resident 3.316/7.518 90 yr old 1.57.7/3.7?

37. 37 Conclusions Older adults could substantially benefit from improved osteoporosis care Older adults could substantially benefit from improved osteoporosis care Although there are additional considerations, frail patients with multiple co- morbidities can be treated safely Although there are additional considerations, frail patients with multiple co- morbidities can be treated safely Improvements will require collaboration of entire Healthcare community Improvements will require collaboration of entire Healthcare community

38. 38 Contact Information For questions about this audio conference please contact Dr. Cathleen Colon-Emeric at cathleen.colon-emeric@va.gov For any questions about the monthly GRECC Audio Conference Series please contact Tim Foley at tim.foley@va.gov or call (734) 222-4328 To evaluate this conference for CE credit please obtain a ‘Satellite Registration’ form and a ‘Faculty Evaluation’ form from the Satellite Coordinator at you facility. The forms must be mailed to EES within 2 weeks of the broadcast