Osteoporosis Treatment in Frail Populations: A Framework for Decision-Making

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

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 had a prior fracture? • If he lived in a nursing home? • If he was 90 years old? • If he had just broken a hip?

4. Does Fracture Risk Warrant Treatment?

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

6. Does Fracture Risk Warrant Treatment?

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. Is treatment safe and effective in older patients? • Bisphosphonates, Teriparatide, Raloxifene • No change in Relative 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. Is therapy cost effective in older patients? • Most models assume 5 years BP treatment • Estimates vary with model assumptions • BUT, nearly all show increasing cost-effectiveness with advancing age • PTH Cost-effectiveness stable with age Schousboe, JAGS 2005;53:1607-1704; Lundquivst, Osteoporos Int 2006;17:1459-71

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

11. What is the lag time before treatment benefit?

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

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

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

15. Why are Older Patients Not Treated?

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

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

18. Common Co-Morbidities • Parkinson’s Disease • BPs Increase BMD, may decrease hip fracture • Renal Insufficiency • BPs have similar efficacy, safe at GFR 30-45 ml/min • Diabetes • BPs similar BMD and bone markers change • Atrial Fibrillation • 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. Nursing Home Residents • Alendronate has similar effect on BMD and no increased side effects • Raloxifene has similar effect on markers of bone turnover • Zoledronic acid after hip fracture, no interaction by NH residence Greenspan,2002Ann Int Med;136:742-6 ; Hansdotter, 2004JAGS 52:779-83; Lyles, 2007 NEJM 357:1799-809.

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

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

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

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

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

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

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

28. Drug Efficacy: Choosing Between Classes

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

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

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

32. Interventions that Improve Osteoporosis Care • Hospital patient interview and 6-month phone call • Doubled osteoporosis management by PCP1 • Faxed clinician reminders • 3-Fold increase in testing and treatment3 • Guidelines to PCPs and educational materials to patients • Increased BMD testing and discussion with MDs4 • Audits of performance • Improved post-fracture osteoporosis testing to 80%5 • 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. Osteoporosis Order Entry Algorithms

34. Provider Education

35. Objective 3 Summary 3. Deciding when and how to treat frail older adults • 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 • Patient preferences and co-morbidities influence choice • Systems Interventions to improve care are needed

36. Would you treat this patient?

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

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