Osteoporosis Treatment
in Frail Populations: A
Framework for DecisionMaking
Cathleen Colón-Emeric, MD, MHSc
Durham VA GRECC and
Duke University Medical Center
1
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
2
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?
3
Does Fracture Risk Warrant
Treatment?
4
FRAX to Estimate Fracture Risk
http://www.shef.ac.uk/FRAX/
5
Does Fracture Risk Warrant
Treatment?
Condition
Low BMD
Fracture Risk
Prior Fracture
Double for each SD
decrease
RR up to 10
1/10 white women/yr
RR 2-3.5
Parkinson’s Disease
RR 2.5
Prostate Cancer
RR 2-4
Stroke
RR 2.5
NH Residence
6
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
7
Is treatment safe and effective in
older patients?
Bisphosphonates,
Teriparatide,
Raloxifene


No change in
Relative Risk
Reduction
Increase in Absolute
Risk Reduction
Fracture rates by age
Fx/10,000 PY

400
300
200
100
0
55 yr
65 yr
75 yr
85 yr
Age during follow-up
Alendronate
Placebo
Hochberg, JBMR 2005;20:971-6; Boonen, JAGS 2006;54:782-9; Bonnen, JAGS 2004;52:1832-9;
8
Boonen, JAGS 2010
Is therapy cost effective in older patients?




Most models assume 5
years BP treatment
Estimates vary with
model assumptions
BUT, nearly all show
increasing costeffectiveness with
advancing age
PTH Cost-effectiveness
stable with age
Cost Effectiveness of Universal
Screen and Treat
40,000
35,000
30,000
25,000
Dollars/ 20,000
QALY 15,000
10,000
5,000
0
-5,000
65 yr
75 yr
85 yr
95 yr
Schousboe, JAGS 2005;53:1607-1704; Lundquivst, Osteoporos Int 2006;17:1459-71
9
Cost Effectiveness with Lower Life
Expectancy
Cost Effectiveness of Risedronate in Steroid
Induced Osteoporosis
40,000
35,000
30,000
Cost in UK 25,000
20,000
Pounds 15,000
10,000
5,000
0
Cost/fx avoided
Cost/QALY
High
Medium
Low
Life Expectancy
Van Staa, Rheum 2007;46:460-6
10
What is the lag time before treatment
benefit?
Time to Effectiveness
25
20
15
Months
10
5
0
Bisphos
PTH
vertebral
Calcitonin Raloxifene Vitamin D
non-vert
Any
11
Objective 1 Summary
Evidence for treating frail older adults
1.
•
•
•
•
2.
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?
12
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
13
VISN-6 Osteoporosis Treatment
2006-8
Barnard, Colon-Emeric, 2008
14
Why are Older Patients Not Treated?
15
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
16
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
17
Common Co-Morbidities

Parkinson’s Disease


Renal Insufficiency


BPs have similar efficacy, safe at GFR 30-45 ml/min
Diabetes


BPs Increase BMD, may decrease hip fracture
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
18
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, 2002 Ann Int Med;136:742-6 ; Hansdotter, 2004 JAGS 52:779-83; Lyles, 2007 NEJM
19
357:1799-809.
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
20
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
21
Is Osteoporosis Treatment
Worthwhile for this patient?

Consider
Life expectancy
 Risk of fracture in remaining years of life
 Drug Efficacy
 Patient preferences
 Safety
 Cost

22
Risk of Fracture in Remaining Life Years
Concept from Walther et al. JAMA 2000; Data from U.S. Life Tables and NHANES,
23
calculated by Colon-Emeric, 2008
Risk of Fracture in Remaining Life
Years
Sickest
Quartile
Risk (%)
of
Fracture
in
Remaining
Life
Remaining Life Years, Women, by health quartile
Remaining Life Years, Men, by health quartile
24
Risk of Fracture in Remaining Life Years
Healthiest
quartile
Risk (%)
of
Fracture
in
Remaining
Life
Remaining Life Years, Women, by health quartile
Remaining Life Years, Men, by health quartile
25
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
26
Drug Efficacy:
NNT with Oral Bisphosphonate
Calculated from publicly available data, Colon-Emeric 2008
27
Drug Efficacy: Choosing Between
Classes
28
Patient Preferences
and Safety
Delivery route
 Frequency
 Pill size
 Compliance
 Cost

29
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)
30
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
31
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

1. Gardner MJ et al. J Bone Joint Surg Am. 2005;87:3-7. ; Solomon DH et al. Mayo Clin Proc. 2005;80:194202; Majumdar SR et al. Ann Intern Med. 2004;141:366-373; Cuddihy MT et al. Osteoporos Int.
32
2004;15:695-700.
Osteoporosis Order Entry
Algorithms
33
Provider Education
34
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
35
Would you treat
this patient?
70 yr old
Remaining Major/Hip
life (yrs)
Fracture
Risk (yrs)
6.7
11/4.2
NNT 1
additional
major Fx
26
80 yr old
3.3
12/5.8
24
Prior fx or
NH resident
90 yr old
3.3
16/7.5
18
1.5
7.7/3.7
?
36
Conclusions
•
•
•
Older adults could substantially benefit
from improved osteoporosis care
Although there are additional
considerations, frail patients with multiple comorbidities can be treated safely
Improvements will require collaboration of
entire Healthcare community
37
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
38