Transcript Improving the Identification and Management of Osteoporosis

Educational Content Developed by
ASBMR and the Faculty Listed Below
Stuart L. Silverman, MD, FACP, FACR (Chair)
Medical Director
Cedars-Sinai Bone Center of Excellence
Los Angeles, California
Michael McClung, MD, FACP, FACE
Director
Oregon Osteoporosis Center
Portland, Oregon
Cheryl L. Lambing, MD, FAAFP
Clinical Professor
University of California, Los Angeles
Los Angeles, California
Ethel S. Siris, MD
Madeline C. Stabile Professor
of Clinical Medicine
Columbia University
New York, New York
E. Michael Lewiecki, MD, FACP, FACE
Clinical Assistant Professor of Medicine
University of New Mexico School of Medicine
Albuquerque, New Mexico
Nelson B. Watts, MD, FACP, MACE
Director
Mercy Health Osteoporosis and
Bone Health Services
Cincinnati, Ohio
Osteoporosis Education for the PCP?
Osteoporosis is
under-recognized
Fractures are not
recognized as sentinel
events
PCPs are critical for
screening, diagnosis, and
treatment
Osteoporosis is
under-treated
ASBMR and
The France
Foundation
Curriculum for PCPs
AAFP chapter meetings
www.osteocme.org
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 provided within this
initiative, including patient education tools and systemsbased approaches to facilitate improving the assessment and
care being provided to patients with osteoporosis
Postmenopausal Osteoporosis in the
Primary Care Setting
•
•
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What is osteoporosis?
Why you should care?
Whom to test and how?
Whom to treat and how?
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 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
48 M
50
40
34 M
36 M
Low Bone Mass
Uncontrolled HT
30
20
10
0
Uncontrolled LDL
Osteoporosis in Perspective
Lifetime risk at age 50
Women
60%
50%
50%
Men
40%
30%
30%
25%
20%
12%
10%
20%
20%
17%
15%
0%
Fracture
Breast Cancer
10%
5%
0%
Fracture
Prostate Cancer
Identified Treatment Gap
NCQA HEDIS
HEDIS Measure
% Compliance*
Beta-blocker persistence after a heart attack
81.3%
Breast cancer screening
70.5%
Colorectal cancer screening
62.4%
Osteoporosis management after a fracture
22.8%
*2011 HMO Rates
NCQA State of Healthcare 2012 - HMO Statistics (Commercial or Medicare data from 2011).
http://www.ncqa.org/Portals/0/State%20of%20Health%20Care/2012/SOHC%20Report%20Web.pdf.
Accessed February 2013.
National Osteoporosis Foundation
2013 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.nof.org/hcp/practice/tools. Accessed March 2013.
Who Should Have a Bone Density Test?
AAFP1 and NOF2
Women age 65 and older and
men age 70 and older
Younger 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
1. Sweet MG, et al. Am Fam Physician. 2009;79(3):193-200.
2. National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis.
www.nof.org. Accessed February 2013.
Reimbursement for DXA
Final Rule
Since 2006, Medicare covers bone
densitometry for five indications
1. Estrogen-deficient women at clinical risk for osteoporosis
2. Patients with vertebral abnormalities
3. Patients receiving long-term glucocorticoids (prednisone ≥ 5
mg/d or equivalent for 3+ months)
4. Patients with primary hyperparathyroidism
5. Patients being monitored to assess the response to an
approved drug
Federal Register. 2006;71(231):67783-67784.
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)
Between -1.0 to -2.5
Osteoporosis
-2.5 and below
Whom to Treat: NOF Guidelines 2013
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)
YES
Candidate for
TREATMENT
YES
http://www.nof.org/hcp/practice/tools. Accessed March 2013.
T-score between -1.0 and -2.5
and increased fracture risk
FRAX
10-y fracture risk
≥ 3% for hip fracture
or
≥ 20% for major osteoporotic fractures
Web Version 3.4
Clinical 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
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
Clinical judgment is required
Do patients with high FRAX scores benefit from medication?
(Unknown)
Watts NB, et al. J Bone Miner Res 2009;24:975-979.
Patient Care Goals
• Identify patients at risk of fractures
• Reduce incidence of fractures
• Maintain quality of life
– Activity
– Independence
– Health
Universal Recommendations for Bone Health
• 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, supplemented if
necessary (age ≥50)
• Regular weight-bearing and muscle-strengthening exercise
• Fall prevention evaluation and training
http://www.nof.org/hcp/practice/tools. Accessed March 2013.
FDA-approved Medications
Osteoporosis
Drug
Estrogen
Calcitonin* (Miacalcin®, Fortical®)
Raloxifene (Evista®)
Ibandronate (Boniva®)
Postmenopausal
Prevent
Treat
Glucocorticoid
-induced
Prevent
Male
Treat
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Alendronate (Fosamax®)
Risedronate (Actonel®, Atelvia®)
Risedronate (Atelvia®)
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Zoledronate (Reclast®)
Denosumab (Prolia™)
Teriparatide (Forteo®)
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Evidence for Fracture Reduction
Drug
Vertebral
Fracture
Nonvertebral
Fracture
Hip
Fracture
Calcitonin

Raloxifene

Ibandronate

Alendronate
Risedronate
Zoledronic acid
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Denosumab
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Teriparatide
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Adapted from Murad MH, et al. J Clin Endocrinol Metab. 2012;97(6):1871-1880.
Clinical Benefit of Bisphosphonates
• Relative risk reduction for fractures
• Postmenopausal women with osteoporosis
• 3 years bisphosphonate treatment
Vertebrae
Khosla S, et al. J Clin Endocrinol Metab. 2012;97(7):2272-2282.
Hip
Bisphosphonates
Side Effects/Safety Concerns
•
•
•
•
Oral formulations may cause esophageal irritation
Can cause acute phase response (IV and high-dose oral)
Contraindicated in patients with hypocalcemia
Limited to patients with good kidney function (GFR > 30 or
35 mL/min)
• Musculoskeletal pain?
• Osteonecrosis of the jaw?
• Atypical femur fractures?
How Long Should
Bisphosphonate Treatment Last?
• Bisphosphonates have a long residence time in bone
– Does long-term treatment create safety concerns that limit
the duration of treatment?
– Given the long retention in bone, with release and possibly
recycling of drug, does cumulative exposure lead to a
reservoir in bone, so that after therapy is stopped, sufficient
drug will be released to exert a continuing benefit?
Porras AG, et al. Clin Pharmacokinet. 1999;36(5):315-328.
Watts NB, et al. J Clin Endocrinol Metab. 2010;95(4):1555-1565.
Long-term Experience with Alendronate
Fit Long-term Extension (FLEX) Study
• 5-year extension to 5 year alendronate trial
• Alendronate patients re-randomized
– Continue alendronate (n = 662)
– Switch to placebo (n = 437)
• Results
– Clinical vertebral fractures were reduced by 55% overall in
continuation group
– Nonvertebral fractures were reduced by 50% in continuing
women with T-scores -2.5 or below at the start of FLEX
Schwartz AV, et al. J Bone Miner Res. 2010;25:976-982.
Clinical Vertebral Fractures
in the FLEX Study
Cumulative Incidence
of Fractures (%)
6
5.3%
ALN 5 years  Placebo 5 years
Alendronate 10 years
5
4
RR  55%
P = 0.013
3
2.4%
2
1
0
0
1
2
3
4
5
417
650
414
646
Years Since FIT
ALN/PLB 437
ALN/ALN 662
428
659
Black DM, et al. JAMA. 2006;296:2927-2938.
429
657
421
654
How Long to Treat with Bisphosphonates?
• 5–10 years appears to be safe for most patients
• Assess for risk:
Lower Risk
Higher Risk
Drug Holiday
After 3-5 years
Drug Holiday
After 10 years
Watts NB and Diab D. J Clin Endocrinol Metab. 2010;95(4):1555-1565.
Denosumab
• Human monoclonal antibody to RANKL
• Decreases osteoclast number and function
• Reduces risk of spine, hip and nonvertebral fractures
• For osteoporosis, SQ dosing every 6 months
• No dose adjustment for decreased kidney function
• Effect is reversible within 6–12 months of stopping
Cummings SR, et al; FREEDOM Trial. N Engl J Med. 2009;361(8):756-765.
Jiang X, et al. Menopause. 2013;20(2):117-119.
Differences Among Antiresorptive Agents
“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
Teriparatide
•
•
•
•
Recombinant human PTH (rhPTH [1-34])
Mechanism of action different from other agents (anabolic)
Daily SC injection
Indicated for patients at high risk for fracture
– Postmenopausal women with osteoporosis
– Men with primary or hypogonadal osteoporosis
– Men and women with osteoporosis associated with sustained
systemic glucocorticoid therapy
• Treatment limited to 2 years, follow with antiresorptive
agent
Forteo PI. http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021318s012lbl.pdf. Accessed Feb 2013.
Han SL, Wan SL. Int J Clin Pract. 2012;66:199-209.
Monitoring
• Monitor 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 the fracture successfully
treated but do NOT receive subsequent medical
assessment and treatment to prevent the next
fracture
Where Are We Now?
The Good News
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
Where Are We Now?
The Bad 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 fill 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 Apr 18. [Epub ahead of print].
Patient Dialog
What Can I Do
as a PCP?
Practical Steps
• Risk/benefit
communication
Decision
Aids
• Shared decision
making
• Electronic med records
• Checklist for risk
• Handouts
• Web resources
Engage the Care Team
• Counseling, follow-up
• ID high-risk patients
Manage Nonadherence
• Identify individual barriers
• Address barriers
Fall Prevention
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Improve lighting
Remove loose rugs
Add grab bars near bathtubs, toilets and stairways
Formal home safety evaluation
Physical therapy for core strength and balance
Eliminate medications that can affect alertness and
balance
• Assistive device evaluation and training
Sweet MG, et al. Am Fam Physician. 2009;79(3):193-200.
What Can I Do as a PCP?
Performance Improvement Activities (PI-CME)
ONLINE PERFORMANCE
IMPROVEMENT MODULES (PIMs)
Stage A:
ASSESS
Stage B:
APPLY
• Measure current
practice patterns
• Show what you are
doing compared to
quality measures and to
your peers
• Complete educational
activities
• Apply new learnings in
practice
Stage C:
• Complete follow-up
EVALUATE
practice pattern
assessments
• See how your practice
has changed
REWARDS TO YOU, THE PHYSICIAN
1.
2.
Quality measures are more
regularly acknowledged. A PIM will
help you stay up to date on the
measures
Earn MOC (Maintenance of
Certification) points
 MOC is REQUIRED for recertification
3.
4.
5.
Practice improvements
System improvements for your
clinic
Better patient outcomes
Performance Improvement CME
MOC Part IV Approved
American Board of Family Medicine (ABFM)
https://achsos.community360.net
https://achsos.community360.net/default.aspx. Accessed April 2013.
Performance Improvement CME
MOC Part IV Approved
American Board of Internal Medicine (ABIM)
www.pi-iq.com/osteoporosis2
Update on Management of Osteoporosis
What is
osteoporosis?
Why should
you care?
Whom to test
and how?
Decreased bone strength predisposing to an
increased risk of fracture
Common, significant cost, morbidity and
mortality
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
Online Tools and Resources
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•
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•
www.osteoCME.org
FRAX
AAFP guidelines
NOF Clinician’s Guide 2013
ACP treatment guidelines 2008
NBHA resource center for Fracture Liaison Services
www.osteoCME.org