2-Osteoporosis-Track..

Report
Update on Management of Osteoporosis
Michael J. Econs, M.D.
Professor of Medicine
Indiana University School of Medicine
Indianapolis, IN 46202
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.
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
Agenda
20 minutes
20 minutes
10 minutes
Slide lecture
Case exercise in small groups
Discussion
Activity Packets
Everyone should have a packet
Resources
for you to
keep
Tear off
now to
take home
Pretest
Case
Worksheet
Posttest
Evaluation
When we’re done, leave on your seat or pass to staff
Please
complete the
quick pretest
NOW
For the
small group
exercise later
Complete these
when the activity
is over
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
Education for PCPs
Live Meetings and
Online CME (free)
www.osteoCME.org
Definition of Osteoporosis
• A skeletal disorder characterized by
– Compromised bone strength predisposing to
– An increased risk of fracture
Normal Bone
• Bone strength reflects the integration of
two main features:
– Bone density
– Bone quality
Osteoporotic Bone
2000 NIH Consensus Development Conference
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
Osteoporosis in Perspective
Americans with Risk Factors,
in Millions
60
53 M
48 M
50
40
36 M
30
20
10
0
Low Bone Uncontrolled Uncontrolled
Mass +/or
HT
LDL
Osteoporosis
Identified Treatment Gap
NCQA HEDIS
HEDIS Measure
% Compliance*
Beta-blocker persistence
after a heart attack
Breast cancer screening
88.5%
Colorectal cancer screening
58.4%
Osteoporosis management for women
after a fracture
25.0%
67.5%
*2012 Medicare Rates
NCQA The State of Health Care Quality 2013.
https://www.ncqa.org/ReportCards/HealthPlans/StateofHealthCareQuality.aspx. Accessed August 2014.
Patient Care Goals
• Identify patients at risk of fractures
• Reduce incidence of fractures
• Maintain quality of life
– Activity
– Independence
– Health
National Osteoporosis Foundation
2014 Guidelines
Major clinical recommendations
• Universal (risk, diet, vitamin D,
exercise, smoking, monitoring)
• Diagnosis (BMD, vertebral imaging,
causes of secondary osteoporosis)
• Monitoring (BMD)
• Treatment (initiation criteria, options,
duration)
http://www. http://nof.org/hcp/resources/913. Accessed August 2014.
2014 Universal Recommendations
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
http://www.nof.org/hcp/practice/tools. Accessed August 2014.
Who Should Have a Bone Density Test?
AAFP and NOF
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
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.
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
Category
Normal
Low bone mass
(osteopenia)
Osteoporosis
T-score
-1.0 and above
-1.0 to -2.5
-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.
Web Version 3.4
http://www.shef.ac.uk/FRAX/. Accessed August 2014.
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
Limitations of FRAX
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)
Helps identify patients who need
treatment
Clinical judgment is required
Can be used to reassure low-risk
patients
Do patients with high FRAX scores
benefit from medication? (Unknown)
Watts NB, et al. J Bone Miner Res 2009;24:975-979.
Whom to Treat: NOF Guidelines 2014
Women ≥ 65 and men ≥ 70
(younger with risk factors)
DXA test
T-score ≤ -2.5 in the lumbar spine,
total hip, or femoral neck
or
Hip or spine fracture (clinical or radiographic)
T-score between -1.0 and -2.5
FRAX
10-y fracture risk
YES
Candidate for
TREATMENT
nof.org/hcp/resources/913. Accessed August 2014.
YES
≥ 3% for hip fracture
or
≥ 20% for major osteoporotic fractures
FDA-approved Medications
Osteoporosis
Drug
Estrogen
Calcitonin* (Miacalcin®, Fortical®)
Raloxifene (Evista®)
Ibandronate (Boniva®)
Postmenopausal
Prevent Treat
Glucocorticoidinduced
Prevent
Male
Treat






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.






Evidence for Fracture Reduction
Drug
Vertebral Nonvertebral
Fracture
Fracture
Hip
Fracture
Calcitonin

Raloxifene

Ibandronate

Alendronate
Risedronate






Zoledronic acid
Denosumab






Teriparatide


Diab DL, Watts NB. Endocrinol Metab Clin North Am. 2013;42(2):305-317.
Choosing an Antiresorptive Agent
“broad spectrum” antifracture efficacy
Efficacy (alendronate, risedronate, zoledronate,
denosumab)
Route of
oral (fasting or with food) or parenteral
administration
Frequency of daily, weekly, monthly, quarterly, twice yearly,
administration once yearly
Side
depends on agent and patient
effects/tolerability
Non-skeletal effects breast cancer reduction (raloxifene)
Cost/insurance generic oral; drugs “administered by health
coverage professional” covered by Medicare Part B
Factors That May Reduce Adherence
Etiology
Patient-related
Possible Factors
•
•
•
•
•
•
Medication-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
Cost
Dosing regimen/frequency
Side effects
Safety misconceptions
Monitoring
• 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
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
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.
Management Rates After Fracture
•
•
•
•
Retrospective cohort study
2000-2009
88,571 women; 41,984 men
Management within 1 year of frailty fracture:
Women
Men
DXA
19.0%
10.2%
Treatment
18.6%
9.6%
Balasubramanian A, et al.J Bone Joint Surg Am. 2014;96(7):e52.
Patients Initiating Treatment
Within 1 Year of Fracture (%)
Treatment Rates Are Decreasing
Women
Men
Year
Balasubramanian A, et al.J Bone Joint Surg Am. 2014;96(7):e52.
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
• CBC
• Calcium, kidney tests, liver
tests, and phosphorus
• 25-OH vitamin D
• 24 hour urine calcium
• Testosterone (in men)
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
Where Are We Now?
The Good News
Improved awareness
Excellent diagnostic tools
available
The Bad News
Under-recognition of patients at risk
for fracture
Decreasing access to DXA
FRAX is a quantitative risk
assessment
Poor patient understanding of
risk/benefit
Increasing patient concerns
about side effects
Safe and effective
individualized treatment
Fewer patients on therapy
Better understanding of
pathogenesis
Poor adherence
Federal initiatives to
improve care
Ross S, et al. Value Health. 2011;14(4):571-581.
Reynolds K, et al. Osteoporos Int. 2013; 24(9):2509-2517.
•
•
30% of patients don’t pick up new
bisphosphonate prescriptions
Risk of fracture increased 30–40%
What Can I Do
as a PCP?
Practical Steps
Patient Dialog
• Risk/benefit discussion
• Shared decision making
Decision Aids
• Electronic records
• Checklist for risk
• Handouts/ Web sites
Engage the Care Team
• Counseling, follow-up
• ID high-risk patients
Manage Nonadherence
• Identify individual barriers
• Address barriers
Summary
What is
osteoporosis?
Decreased bone strength predisposing to an
increased risk of fracture
Why should
you care?
Whom to test
and how?
Common, significant cost, morbidity and
mortality
DXA for all women by age 65, higher risk
women earlier; FRAX is a useful tool
Individuals at high risk of fracture; approved
agents are safe and effective; treatment
decisions must be individualized
Whom to treat
and how?
Case Workshop: Small Group Exercise
Everyone should have a packet
We’re going to use the green sheet for this exercise.
Resources
for you to
keep
1.
2.
3.
4.
5.
Pretest
Case
Worksheet
Posttest
I will present part of a case
Your small group will have 4 minutes to discuss it
After 4 minutes, I’ll present the next part of the case
You will have 4 minutes to discuss next steps
Finally, we will review the case for 10 minutes
Evaluation
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
• Social
Emily: Patient History 2
−
−
−
−
−
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
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.
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
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 4 0 0
Minutes
Seconds
EMILY DISCUSSION # 1
What are Emily’s risk
factors for future
fracture?
______________________
______________________
What tests would you
order?
______________________
______________________
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
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? _____________
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
0 4 0 0
Minutes
Seconds
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
Group Review of Case
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
Online Tools and Resources
• www.osteoCME.org
– Free online CME
– PQRSwizard®
• www.nof.org
– Bone Health Basics
– Patient resources, support
– NOF Clinician’s Guide 2014
• FRAX Tool
– www.shef.ac.uk/FRAX/
• AAFP guidelines
– Sweet MG, et al. Am
Fam Physician.
2009;79(3):193-200.
• ACP treatment guidelines
– Qaseem A, et al. Ann Intern Med.
2008;149(6):404-415.
• Fracture Liaison Services
– NBHA resource center: www.nbha.org
Please Leave Blue And Green Handouts
on your Chair or Hand to Meeting Staff
at the Door or Registration Desk
Keep the white page
(page 1)
Case
Worksheet
Pretest
Evaluation
Resources
for you to
keep
Posttest
Please visit
www.OsteoCME.org
for more education
Questions or
Comments?
For more education
and resources please
visit
www.osteoCME.org

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