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

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Osteoporosis Osteoporosis Treatment in Frail Treatment in Frail

Populations: A Populations: A Framework for Framework for

Decision-MakingDecision-MakingCathleen ColCathleen Colón-Emeric, MD, ón-Emeric, MD,

MHScMHSc

Durham VA GRECC andDurham VA GRECC and

Duke University Medical Duke University Medical CenterCenter

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ObjectivesObjectives

1.1. Evidence for treating frail older Evidence for treating frail older adultsadults

2.2. Why older adults are not getting Why older adults are not getting treatedtreated

3.3. Deciding when and how to treat frail Deciding when and how to treat frail older adults: a framework for older adults: a framework for decision makingdecision making

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Would you treat Would you treat this patient?this patient?70 yr old male with EF 25%, 70 yr old male with EF 25%,

mild dementia, T score hip -2.6mild 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?

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Does Fracture Risk Warrant Does Fracture Risk Warrant Treatment?Treatment?

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FRAX to Estimate FRAX to Estimate Fracture RiskFracture Risk

http://www.shef.ac.uk/FRAX/

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Does Fracture Risk Warrant Does Fracture Risk Warrant Treatment?Treatment?

ConditionCondition Fracture RiskFracture RiskLow BMDLow BMD Double for each SD Double for each SD

decreasedecrease

NH ResidenceNH Residence RR up to 10RR up to 10

1/10 white 1/10 white women/yrwomen/yr

Prior FracturePrior Fracture RR 2-3.5 RR 2-3.5

Parkinson’s Parkinson’s DiseaseDisease

RR 2.5RR 2.5

Prostate CancerProstate Cancer RR 2-4RR 2-4

StrokeStroke RR 2.5RR 2.5

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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

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Is treatment safe and Is treatment safe and effective in older patients?effective in older patients? BisphosphonateBisphosphonate

s, Teriparatide, s, Teriparatide, RaloxifeneRaloxifene No change in No change in

Relative Risk Relative Risk ReductionReduction

Increase in Increase in Absolute Risk Absolute Risk ReductionReduction

Fracture rates by age

0

100

200

300

400

55 yr 65 yr 75 yr 85 yr

Age during follow-up

Fx/1

0,00

0 PY

Alendronate Placebo

Hochberg, JBMR 2005;20:971-6; Boonen, JAGS 2006;54:782-9; Bonnen, JAGS 2004;52:1832-9; Boonen, JAGS 2010

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Is therapy cost effective in Is therapy cost effective in older patients?older patients? Most models assume Most models assume

5 years BP 5 years BP treatmenttreatment

Estimates vary with Estimates vary with model assumptionsmodel assumptions

BUT, nearly all show BUT, nearly all show increasing cost-increasing cost-effectiveness with effectiveness with advancing ageadvancing age

PTH Cost-PTH Cost-effectiveness stable effectiveness stable with agewith age

-5,000

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

Dollars/ QALY

65 yr 75 yr 85 yr 95 yr

Cost Effectiveness of Universal Screen and Treat

Schousboe, JAGS 2005;53:1607-1704; Lundquivst, Osteoporos Int 2006;17:1459-71

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Cost Effectiveness with Cost Effectiveness with Lower Life ExpectancyLower Life Expectancy

05,000

10,00015,00020,00025,00030,00035,00040,000

Cost in UK Pounds

High Medium Low

Life Expectancy

Cost Effectiveness of Risedronate in Steroid Induced Osteoporosis

Cost/fx avoided

Cost/QALY

Van Staa, Rheum 2007;46:460-6

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

0

5

10

15

20

25

Months

Bisphos PTH Calcitonin Raloxifene Vitamin D

Time to Effectiveness

vertebral non-vert Any

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Objective 1 SummaryObjective 1 Summary

1.1. Evidence for treating frail older Evidence for treating frail older adultsadults

• Higher risk for fractureHigher risk for fracture• Treatments appear to be equally safe, Treatments appear to be equally safe,

and have greater absolute and have greater absolute fracture reduction fracture reduction

• Cost effectiveness increases with ageCost effectiveness increases with age• Rapid onset of effectivenessRapid onset of effectiveness

2.2. Why are older adults not getting Why are older adults not getting treated?treated?

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Older Patients are Rarely Older Patients are Rarely Treated for OsteoporosisTreated for Osteoporosis After a hip fractureAfter a hip fracture

Fewer than 10% receive osteoporosis Fewer than 10% receive osteoporosis evaluation evaluation

Fewer than 20% receive osteoporosis Fewer than 20% receive osteoporosis treatmenttreatment

U.S., Canada, Europe, Academic U.S., Canada, Europe, Academic Centers, Community Practices, VA Centers, Community Practices, VA Medical CentersMedical 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

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VISN-6 Osteoporosis VISN-6 Osteoporosis Treatment 2006-8Treatment 2006-8

Barnard, Colon-Emeric, 2008

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Why are Older Patients Not Why are Older Patients Not Treated?Treated?

System Factors

Provider Factors

Patient Factors

Osteoporosis Rx

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Provider FactorsProvider Factors

KnowledgeKnowledge Clinical Practice GuidelinesClinical Practice Guidelines

Attitudes: Provider SurveyAttitudes: Provider Survey Safe and effective, even in NH residentsSafe and effective, even in NH residents ““Not as important” as competing co-Not as important” as competing co-

morbiditiesmorbidities Not cost effectiveNot cost effective Too many side effectsToo many side effects

Beliefs: “Not my role”Beliefs: “Not my role” Orthopedic surgeons vs. PCPsOrthopedic surgeons vs. PCPs

Colon-Emeric, J Am Med Dir Assoc 2006; Skedros, JBMR 2006; Dreinhoffer, Osteop Int 2005

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Patient FactorsPatient Factors

Knowledge/Attitudes/BeliefsKnowledge/Attitudes/Beliefs Inadequate informationInadequate information ““Women’s” diseaseWomen’s” disease ““I’ve never broken a bone”I’ve never broken a bone” Concern about side effects especially ONJConcern about side effects especially ONJ

Co-morbiditiesCo-morbidities Nursing Home ResidentsNursing Home Residents Life expectancyLife expectancy

Ribheiro et al. Health Care for Women Int, 2000

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Common Co-MorbiditiesCommon Co-Morbidities

Parkinson’s DiseaseParkinson’s Disease BPs Increase BMD, may decrease hip fractureBPs Increase BMD, may decrease hip fracture

Renal InsufficiencyRenal Insufficiency BPs have similar efficacy, safe at GFR 30-45 BPs have similar efficacy, safe at GFR 30-45

ml/minml/min DiabetesDiabetes

BPs similar BMD and bone markers changeBPs similar BMD and bone markers change Atrial FibrillationAtrial Fibrillation

Zoledronic acid increased serious events in Zoledronic acid increased serious events in younger women, but no increased risk in older younger women, but no increased risk in older hip fx patientship 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

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Nursing Home ResidentsNursing Home Residents

Alendronate has similar effect on Alendronate has similar effect on BMD and no increased side effects BMD and no increased side effects

Raloxifene has similar effect on Raloxifene has similar effect on markers of bone turnover markers of bone turnover

Zoledronic acid after hip fracture, no Zoledronic acid after hip fracture, no interaction by NH residenceinteraction by NH residence

Greenspan, 2002 Ann Int Med;136:742-6 ; Hansdotter, 2004 JAGS 52:779-83; Lyles, 2007 NEJM 357:1799-809.

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System FactorsSystem Factors

Multiple “silos” providing Multiple “silos” providing uncoordinated careuncoordinated care

DXA availability for frail patientsDXA availability for frail patients Formularies, Prior AuthorizationsFormularies, Prior Authorizations Availability of Infusion ServicesAvailability of Infusion Services Financial disincentives for Financial disincentives for

community nursing homescommunity nursing homes

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Objective 2 SummaryObjective 2 Summary

2. Why older adults are not getting 2. Why older adults are not getting treatedtreated

• Patient issuesPatient issues• Provider issuesProvider issues• System issuesSystem issues

3. Deciding when and how to treat 3. Deciding when and how to treat frail older adults: a framework for frail older adults: a framework for decision makingdecision making

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Is Osteoporosis Treatment Is Osteoporosis Treatment Worthwhile for this Worthwhile for this patient?patient? ConsiderConsider

Life expectancyLife expectancy Risk of fracture in remaining years of Risk of fracture in remaining years of

lifelife Drug EfficacyDrug Efficacy Patient preferencesPatient preferences SafetySafety CostCost

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Risk of Fracture in Remaining Risk of Fracture in Remaining Life YearsLife Years

Concept from Walther et al. JAMA 2000; Data from U.S. Life Tables and NHANES, calculated by Colon-Emeric, 2008

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Risk of Fracture in Risk of Fracture in Remaining Life YearsRemaining Life Years

Risk (%) of Fracture in Remaining Life

Remaining Life Years, Women, by health quartile

Remaining Life Years, Men, by health quartile

Sickest Quartile

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Risk of Fracture in Remaining Risk of Fracture in Remaining Life YearsLife Years

Risk (%) of Fracture in Remaining Life

Remaining Life Years, Women, by health quartile

Remaining Life Years, Men, by health quartile

Healthiest quartile

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Risk of Fracture in Remaining Risk of Fracture in Remaining Life YearsLife Years

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

Remaining Life Years, Women, by health quartile

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Drug Efficacy:Drug Efficacy:NNT with Oral NNT with Oral

BisphosphonateBisphosphonate

Calculated from publicly available data, Colon-Emeric 2008

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Drug Efficacy: Choosing Drug Efficacy: Choosing Between ClassesBetween Classes

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Patient Preferences Patient Preferences and Safetyand Safety

Delivery routeDelivery route FrequencyFrequency Pill sizePill size ComplianceCompliance CostCost

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Other Conditions that Other Conditions that Influence Choice of TherapyInfluence Choice of Therapy

Gastritis, ulcer disease, dysphagia Gastritis, ulcer disease, dysphagia (oral BPs)(oral BPs)

Prior DVT, recent fracture Prior DVT, recent fracture (raloxifene)(raloxifene)

Hypercalcemia (PTH)Hypercalcemia (PTH) Prior cancer or radiation (PTH)Prior cancer or radiation (PTH) Upcoming major dental procedures Upcoming major dental procedures

(BPs)(BPs) Cognitive, mobility impairment (oral Cognitive, mobility impairment (oral

BPs)BPs) Number of Medications (monthly or Number of Medications (monthly or

yearly)yearly)

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Practical ConsiderationsPractical Considerations

Addressing Vitamin D deficiencyAddressing Vitamin D deficiency Prevalence 12-70%Prevalence 12-70% Measurement vs. universal repletionMeasurement vs. universal repletion

Need for DXANeed for DXA Often not feasibleOften not feasible Not necessary to start treatment after Not necessary to start treatment after

fracturefracture Only if it will influence my treatment Only if it will influence my treatment

decisionsdecisions

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Interventions that Improve Interventions that Improve Osteoporosis CareOsteoporosis Care

Hospital patient interview and 6-month phone callHospital patient interview and 6-month phone call Doubled osteoporosis management by PCPDoubled osteoporosis management by PCP11

Faxed clinician remindersFaxed clinician reminders 3-Fold increase in testing and treatment3-Fold increase in testing and treatment33

Guidelines to PCPs and educational materials to Guidelines to PCPs and educational materials to patientspatients Increased BMD testing and discussion with Increased BMD testing and discussion with

MDsMDs44 Audits of performanceAudits of performance

Improved post-fracture osteoporosis testing to Improved post-fracture osteoporosis testing to 80%80%55

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.

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Osteoporosis Order Entry Osteoporosis Order Entry AlgorithmsAlgorithms

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Provider EducationProvider Education

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Objective 3 SummaryObjective 3 Summary

3. 3. Deciding when and how to treat frail Deciding when and how to treat frail older adultsolder adults Most co-morbidities are not Most co-morbidities are not

contraindications to treatment contraindications to treatment In patients at high risk for fracture with at In patients at high risk for fracture with at

least 2 years of remaining life expectancy, least 2 years of remaining life expectancy, consider pharmacologic therapyconsider pharmacologic therapy

Patient preferences and co-morbidities Patient preferences and co-morbidities influence choiceinfluence choice

Systems Interventions to improve care are Systems Interventions to improve care are neededneeded

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Would you treat Would you treat this patient?this patient?

RemainiRemaining life ng life (yrs)(yrs)

Major/Major/HipFractHipFracture Risk ure Risk (yrs)(yrs)

NNT 1 NNT 1 additionadditional major al major FxFx

70 yr old70 yr old 6.76.7 11/4.211/4.2 2626

80 yr old80 yr old 3.33.3 12/5.812/5.8 2424

Prior fx or Prior fx or NH NH residentresident

3.33.3 16/7.516/7.5 1818

90 yr old90 yr old 1.51.5 7.7/3.77.7/3.7 ??

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ConclusionsConclusions

• Older adults could substantially Older adults could substantially benefit from improved benefit from improved osteoporosis careosteoporosis care

• Although there are additional Although there are additional considerations, frail patients with considerations, frail patients with multiple co-morbidities can be multiple co-morbidities can be treated safely treated safely

• Improvements will require Improvements will require collaboration of entire Healthcare collaboration of entire Healthcare community community

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Contact Information• For questions about this audio conference

please contact Dr. Cathleen Colon-Emeric at [email protected]

• For any questions about the monthly GRECC Audio Conference Series please contact Tim Foley at [email protected] 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