- Emily has multiple risk factors for future fracture, including her recent wrist fracture, menopause, smoking history, and lack of exercise.
- The groups would order a DXA scan to assess her bone mineral density and potentially FRAX to further evaluate her fracture risk.
- Additional labs such as calcium, vitamin D, and a CBC may provide more information.
1. Michael J. Econs, M.D.
Professor of Medicine
Indiana University School of Medicine
Indianapolis, IN 46202
Update on Management of Osteoporosis
2. 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.
3. 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
4. Agenda
20 minutes Slide lecture
20 minutes Case exercise in small groups
10 minutes Discussion
Resources
for you to
keep
Pretest Case
Worksheet
Posttest Evaluation
Tear off
now to
take home
Please
complete the
quick pretest
NOW
For the
small group
exercise later
Complete these
when the activity
is over
When we’re done, leave on your seat or pass to staff
Activity Packets
Everyone should have a packet
5. 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
6. 2000 NIH Consensus Development Conference
Definition of Osteoporosis
Normal Bone
Osteoporotic Bone
• A skeletal disorder characterized by
– Compromised bone strength predisposing to
– An increased risk of fracture
• Bone strength reflects the integration of
two main features:
– Bone density
– Bone quality
7. 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
8. Osteoporosis in Perspective
53 M
36 M
48 M
0
10
20
30
40
50
60
Low Bone
Mass +/or
Osteoporosis
Uncontrolled
HT
Uncontrolled
LDL
Americans
with
Risk
Factors,
in
Millions
9. Identified Treatment Gap
NCQA HEDIS
HEDIS Measure % Compliance*
Beta-blocker persistence
after a heart attack
88.5%
Breast cancer screening 67.5%
Colorectal cancer screening 58.4%
Osteoporosis management for women
after a fracture
25.0%
NCQA The State of Health Care Quality 2013.
https://www.ncqa.org/ReportCards/HealthPlans/StateofHealthCareQuality.aspx. Accessed August 2014.
*2012 Medicare Rates
10. Patient Care Goals
• Identify patients at risk of fractures
• Reduce incidence of fractures
• Maintain quality of life
– Activity
– Independence
– Health
11. National Osteoporosis Foundation
2014 Guidelines
• Universal (risk, diet, vitamin D,
exercise, smoking, monitoring)
• Diagnosis (BMD, vertebral imaging,
causes of secondary osteoporosis)
• Monitoring (BMD)
• Treatment (initiation criteria, options,
duration)
Major clinical recommendations
http://www. http://nof.org/hcp/resources/913. Accessed August 2014.
12. 2014 Universal Recommendations
http://www.nof.org/hcp/practice/tools. Accessed August 2014.
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
13. Who Should Have a Bone Density Test?
AAFP and NOF
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.
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
14. 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 T-score
Normal -1.0 and above
Low bone mass
(osteopenia)
-1.0 to -2.5
Osteoporosis -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.
17. 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
Helps identify patients who need
treatment
Can be used to reassure low-risk
patients
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)
Clinical judgment is required
Do patients with high FRAX scores
benefit from medication? (Unknown)
Limitations of FRAX
Watts NB, et al. J Bone Miner Res 2009;24:975-979.
18. Whom to Treat: NOF Guidelines 2014
Women ≥ 65 and men ≥ 70
(younger with risk factors)
T-score between -1.0 and -2.5
T-score ≤ -2.5 in the lumbar spine,
total hip, or femoral neck
or
Hip or spine fracture (clinical or radiographic)
DXA test
≥ 3% for hip fracture
or
≥ 20% for major osteoporotic fractures
FRAX
10-y fracture risk
Candidate for
TREATMENT
YES
YES
nof.org/hcp/resources/913. Accessed August 2014.
21. Choosing an Antiresorptive Agent
Efficacy
“broad spectrum” antifracture efficacy
(alendronate, risedronate, zoledronate,
denosumab)
Route of
administration
oral (fasting or with food) or parenteral
Frequency of
administration
daily, weekly, monthly, quarterly, twice yearly,
once yearly
Side
effects/tolerability
depends on agent and patient
Non-skeletal effects breast cancer reduction (raloxifene)
Cost/insurance
coverage
generic oral; drugs “administered by health
professional” covered by Medicare Part B
22. Factors That May Reduce Adherence
Etiology Possible Factors
Patient-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
Medication-related • Cost
• Dosing regimen/frequency
• Side effects
• Safety misconceptions
23. • 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
Monitoring
24. 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
25. 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.
26. Management Rates After Fracture
Women Men
DXA 19.0% 10.2%
Treatment 18.6% 9.6%
• Retrospective cohort study
• 2000-2009
• 88,571 women; 41,984 men
• Management within 1 year of frailty fracture:
Balasubramanian A, et al.J Bone Joint Surg Am. 2014;96(7):e52.
27. Treatment Rates Are Decreasing
Patients
Initiating
Treatment
Within
1
Year
of
Fracture
(%)
Balasubramanian A, et al.J Bone Joint Surg Am. 2014;96(7):e52.
Year
Women Men
28. 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
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
• CBC
• Calcium, kidney tests, liver
tests, and phosphorus
• 25-OH vitamin D
• 24 hour urine calcium
• Testosterone (in men)
29. Where Are We Now?
Improved awareness
Excellent diagnostic tools
available
FRAX is a quantitative risk
assessment
Safe and effective
individualized treatment
Better understanding of
pathogenesis
Federal initiatives to
improve care
The Good News
Under-recognition of patients at risk
for fracture
Decreasing access to DXA
Poor patient understanding of
risk/benefit
Increasing patient concerns
about side effects
Fewer patients on therapy
Poor adherence
• 30% of patients don’t pick up new
bisphosphonate prescriptions
• Risk of fracture increased 30–40%
Ross S, et al. Value Health. 2011;14(4):571-581.
Reynolds K, et al. Osteoporos Int. 2013; 24(9):2509-2517.
The Bad News
30. 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
31. Summary
What is
osteoporosis?
Decreased bone strength predisposing to an
increased risk of fracture
Why should
you care?
Common, significant cost, morbidity and
mortality
Whom to test
and how?
DXA for all women by age 65, higher risk
women earlier; FRAX is a useful tool
Whom to treat
and how?
Individuals at high risk of fracture; approved
agents are safe and effective; treatment
decisions must be individualized
32. Case Workshop: Small Group Exercise
Everyone should have a packet
We’re going to use the green sheet for this exercise.
1. I will present part of a case
2. Your small group will have 4 minutes to discuss it
3. After 4 minutes, I’ll present the next part of the case
4. You will have 4 minutes to discuss next steps
5. Finally, we will review the case for 10 minutes
Resources
for you to
keep
Pretest Case
Worksheet
Posttest Evaluation
33. 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
34. Emily: Patient History 2
• Social
− 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
35. 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.
36. 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
37. 0
4
0Minutes Seconds
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
EMILY DISCUSSION # 1
What are Emily’s risk
factors for future
fracture?
______________________
______________________
What tests would you
order?
______________________
______________________
38. 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
39. 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? _____________
40. 0
4
0Minutes Seconds
0
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
41. 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
42. 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
Group Review of Case
43. Online Tools and Resources
• www.osteoCME.org
– Free online CME
– PQRSwizard®
• FRAX Tool
– www.shef.ac.uk/FRAX/
• AAFP guidelines
– Sweet MG, et al. Am
Fam Physician.
2009;79(3):193-200.
• www.nof.org
– Bone Health Basics
– Patient resources, support
– NOF Clinician’s Guide 2014
• ACP treatment guidelines
– Qaseem A, et al. Ann Intern Med.
2008;149(6):404-415.
• Fracture Liaison Services
– NBHA resource center: www.nbha.org
44. Please Leave Blue And Green Handouts
on your Chair or Hand to Meeting Staff
at the Door or Registration Desk
Please visit
www.OsteoCME.org
for more education
Resources
for you to
keep
Pretest
Case
Worksheet
Posttest
Evaluation
Keep the white page
(page 1)