One Year Follow-up - Amazon Web Services

advertisement
Captured Fracture:
Management
Christine Simonelli, MD
Director, Osteoporosis Services
HealthEast Clinics, St. Paul, MN
Assoc Clin Prof University of MN, Mpls, MN
Rationale For Post-Fracture
Attention To Osteoporosis

Almost one of every two Caucasian women
will experience an osteoporotic fracture at
some point in her lifetime1

In the USA ~ 1.5 million fractures per year
are attributable to osteoporosis




700,000 vertebral fractures
250,000 forearm (Colles’) fractures
250,000 hip fractures
300,000 fractures of other limb sites1
1. Riggs B, Melton LJ III. The worldwide problem of osteoporosis: insights afforded by
epidemiology. Bone. 1995;17(suppl 5):S505–S511.
Treatment Gap
• Currently no accepted protocol for adults
hospitalized with a fragility fracture
• Why hospitals should assess fracture patients for
osteoporosis:
•
•
•
•
Improve quality of care for high risk patients
Window of opportunity
JCAHO accreditation
HEDIS and NCQA
Skeletal Fragility: Fractures Predict
Fractures
Ross PD et al. Calcif Tissue Int 1993;5:S135
Wasnich R. Am J Med. 1993;95(Suppl 5A):6S-10S.
Bone Turnover and Calcium
Metabolism in Patient With A Hip FX
• BMD decreases by 4-5% at the uninjured
hip in the first year following hip fracture
• Approximately 5-fold bone loss
• 2.4% loss of LS BMD following hip fracture
• Bone quality/osteomalacia
• Subclinical vitamin D deficiency and secondary
hyperparathyroidism is very common
• Decrease in bone formation
• Under-carboxylated osteocalcin
Treatment Gap
• Currently no universally accepted protocol for
adults hospitalized with a fragility fracture
• Why hospitals should assess fracture patients for
osteoporosis:
•
•
•
•
Improve quality of care for high risk patients
Window of opportunity
JCAHO accreditation
HEDIS and NCQA
Diagnosis and Treatment of Fracture
Patients: June 1996-Dec 1997
• Pilot of PM women hospitalized with lowimpact fracture
• Admission/discharge calcium, vitamin D,
osteoporosis medication
• One-year telephone F/U
•
•
•
•
Calcium, Vitamin D, multivitamin
Osteoporosis medication use
BMD testing
QOL and functional measures
Baseline Data
• 301 females ≥45 yrs. consented, and 227
available for 1 year follow-up
• 89% at least age 70
• 71% with hip fracture, 7% VCF, 5%
forearm fracture
• 45% with prior fracture likely to be fragility
fracture as an adult
Simonelli C, Chen Y, Morancey J, et al. J Gen Int Med 2003,Vol.18;17-22
Admission/D/C Care of Patients
Admitted With Low-Impact Fracture
‡
(Calcium ≥1000mg/d)
*NS from Adm
‡ More likely to be diagnosed if prior fx p=0.008
One-year Follow-up: Patients
Admitted With Low-Impact Fracture
N=227
D/C
p<.001
1 yr. F/U
p=NS
Estrogen 24; alendronate 12;
calcitonin 14; combination 8
Simonelli C, Morancey J, et al. J Gen Int Med 2003,Vol.18;17-22
Quality of Life Measures at One Year
What Might Be Ideal Secondary
Prevention Following Fragility FX?
• Adequate nutrition
• Calcium, vitamin D, protein intake
• Laboratory evaluation*
• Fall risk management/protection
• BMD testing
• Osteoporosis medication therapy
• Consider life expectancy
• Consider mobility, level of risk
• Co-morbidities
Proposed an Education Intervention
• Partnered with Orthopedic Collaborative
Practice
• Internal Medicine
• Family Practice
• HealthEast Hospital Administration
Post-fracture: Education Intervention
N=186, June 1999-Dec 2002, N=186
• Education of care providers
• Physicians
• Nurses, physical therapists, social workers
• Geriatric nurse practitioner
• Education to patient and family
• Chart documentation
• System approved recommendations
• Placed on chart with copy to primary MD
Post-fracture Recommendations
• Calcium intake ≥1200 mg/day, including diet
• Vitamin D supplement ≥ 1000IU/day
• Avoidance of tobacco products and
excessive alcohol
• Home safety and fall prevention
• Candidacy for hip protectors
• Further laboratory evaluation and additional
treatment if considered appropriate
• List of BMD testing sites
Percent
Comparison of Pilot With Education
Intervention: OP Awareness and Ca use
‡
*p=.01
‡p<.001
‡
‡
Percent Responding
Comparison of Pilot With Education
Intervention: Osteoporosis Medication
Pilot vs. Education = NS for all pairs
What Are The Barriers To Care?
• Surveyed physicians
• 75 primary care MDs and 35 orthopaedic
surgeons
• 31% response rate
Simonelli C, Killeen K, Swanson,L, Scheltema K. Mayo Clinic Proc, 2002
Percent Responding
Who is Responsible For Addressing
OP Risk in The FX Patient?
Simonelli C, Killeen K, Swanson,L, et al. Mayo Clinic Proc, 2002
What Are Factors Limiting Treatment
of OP in The Fracture Patient?
Physicians Report Being More Likely
To Treat:
How Should We Increase Number of
Fracture Patients Treated For OP?
100
100
Primary Care
Ortho
80
70
60
50
40
22
20
22
13
13
0
0
Include OP
mnagement in
ortho orders
NP see all patients
Refer for
evaluation after D/
C
Increase MD
awareness
In Our System We Had A Problem
• Primary care MDs
• Want to be in charge
• Believe they are taking care of the problem
• Data suggests it’s not getting done
• Orthopaedists
• Willing to identify the patients
• Want osteoporosis care provided by
someone else
Where Do We Go From Here?
Post-fracture Intervention Models
• Primary care physician-generated referral for
osteoporosis evaluation and treatment in hospital
• ‘Automatic’ referral for osteoporosis evaluation and
management after discharge to PCC or osteo center
• Orthopaedic physician-generated referral for nurse
practitioner evaluation/recommendation while patient
hospitalized
Post-fracture Working Group (HealthEast Osteoporosis Care, Mayo Clinic,
Northwestern University), J Bone Joint Surg, 2003
Post-fracture Intervention Models
• Primary care physician-generated referral for
osteoporosis evaluation and treatment in hospital
 ‘Automatic’ referral for osteoporosis evaluation and
management after discharge to PCC or osteo center
• Orthopaedic physician-generated referral for nurse
practitioner evaluation/recommendation while patient
hospitalized
Post-fracture Working Group (HealthEast Osteoporosis Care, Mayo Clinic,
Northwestern University), J Bone Joint Surg, 2003
Physician Referral in Hospital
• UPSIDE:
• All patients seen, laboratory testing done and
opportunity to start therapy if deemed appropriate
• DOWNSIDE:
• Requires cooperation of primary physicians to
generate referral
• Need team of physicians willing to do referrals
• Billing issues related to global fees, etc.
• Time consuming for consulting physicians
• Will need follow-up of lab tests after discharge
• May not have sufficient data to start therapy
Referral to “Osteoporosis Clinic”
For Evaluation After Discharge
• UPSIDE:
• Patient is scheduled for DXA and clinic visit
• Lab tests can be done in advance of visit and
treatment started after labs reviewed
• Takes primary physician and orthopaedist out of
the loop (good-news/bad news)
• DOWNSIDE:
•
•
•
•
Territorial issues in some settings
Works best in a tertiary referral system
Need place to refer
‘No’ care unless follow-up appointment kept
Use of NP For Limited Consultation
On Fracture Patients
• UPSIDE
• Generated by orthopaedist (option on admitting orders)
• NP orders nutritional support, certain lab tests and may
suggest specific therapy options
• Recommends additional lab tests, BMD testing, etc.
• DOWNSIDE
• Requires skilled orthopaedic/geriatric NP and MD backup
• Unable to perform certain lab tests in hospital
• Follow-up dependent on cooperation of primary MD
• Limited nurse practitioner billing
• Requires support of hospital
Post-fracture: Phase III (Aug 2001-Jan
2003 N= 86 women and men)
• Orthopaedist requests osteoporosis consult
• Nurse practitioner consultation
• Chart review, PE including MME and Functional
Status
• Patient/family education materials
• Makes recommendations regarding:
• BMD testing after discharge
• Fall prevention, hip protectors, etc
Characteristics of Study Populations
Education
N= 184
Education and
Consult N=83
% Prior FX
76
49
54*
58
% Hip FX
53
95*
% ≥70 yrs
68
75
Prior BMD
9
21*
% Female
*p<.01
All statistics done using logistic regression correcting for
differences in baseline values
Phase III: Effectiveness of Nurse
Practitioner Consultation At Discharge
Baseline Data
Education
NP Consult
100
100
80
70
61
60
49
40
40
30
28
26
20
17 14
17
0
OP in chart
CA >1000mg
0
Vit D >400IU
OP med
‡
*p<.001
p<.003
p<.001
p<.002
Phase III: Effectiveness of Nurse
Practitioner : One Year Follow-up
80% Bisphosphonate
16% Calcitonin
4% Raloxifene
*
‡*
*P<.02, baseline vs. educ. or consult
‡ P =0.02, Consult vs education, correcting for age
p=NS
Patients Who Were More Likely To
Be Treated After NP Consult
•
•
•
•
•
Those under 80*
Those with prior fracture*
Those with BMD testing‡
More females received treatment and
more hip fracture patients vs. non-hip
fracture patients (NS)
86% of those started on medication in
hospital were still on RX at one year
*p<.01
‡p<.001
Phase III: Impact of Nurse Practitioner
Consultation In-hospital
• Improved
• Osteoporosis awareness
• % of patients supplemented with calcium and
vitamin D
• Use of osteoporosis medication RX
• Diagnosed high incidence of metabolic
abnormality
• Stimulated primary care physicians to assume
more active role in osteoporosis care
Current HealthEast Post Fracture:
Standard of Care
• Includes orthopaedist-generated consult to
osteoporosis service on discharge for all
hip fracture patients
• Other patients with low impact fractures
also referred
• All fracture patients given 50,000IU vitamin
D2 on admission
Why Referral on Discharge?
• Hospital concern about ordering additional
lab tests during admission
• Some lab tests may not be accurate while
hospitalized
• Known high incidence of various metabolic
abnormalities favors consult visit with lab
testing and then decision on proper
treatment.
NOF Guidelines for Initiating
Pharmacologic Therapy
Initiate pharmacologic therapy in men and
postmenopausal women* in presence of:
Fracture
T-score
FRAX®
Assessment
(T-score between
–1.0 and –2.5)
» A vertebral or hip fracture
» T-score ≤ –2.5 at femoral neck or
spine†
» WHO 10-year probability of any
major osteoporotic fracture ≥ 20%
» WHO 10-year probability of a hip
fracture ≥ 3%
FRAX® is a registered trademark of Professor J.A. Kanis. University of Sheffield.
National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. 2008.
Post-Fracture Management
• By definition, patient has osteoporosis
• Can get DXA to determine severity
• Half of all fractures occur in patients with BMD
not in osteoporosis range
• Evaluate for contributing factors
• Initiate calcium and vitamin D
supplementation
• Consider physical therapy, fall prevention
Decision to treat does not require BMD
but advisable if available!
Bone Turnover and Calcium
Metabolism in Patient With A Hip FX
• BMD decreases by 4-5% at the uninjured
hip in the first year following hip fracture
• Approximately 5-fold increased bone loss
• 2.4% loss of LS BMD following hip fracture
• Bone quality/osteomalacia
• Subclinical vitamin D deficiency and secondary
hyperparathyroidism is very common
• Decrease in bone formation
• Under-carboxylated osteocalcin
Laboratory Assessment
• Consider the following:
• Complete blood cell count (need indication other than osteoporosis)
• Renal/liver function
• Serum chemistries including calcium and alkaline phosphatase
• PTH panel
• 25(OH) vitamin D
• 24-hour urine for calcium
• Gonadal function (in men)
• sPEP,
• Individualize need for:
• TTG, 24-hour urine cortisol, fluoride level, TSH, free T4
Vondracek, SF and Hansenm LB. Am J Health Syst Pharm. 2004;61:1801-1811.
US Department of Health and Human Services, Office of the Surgeon General. Prevention and
Treatment in Bone Health and Osteoporosis: a Report by the Surgeon General. Rockville, MD. 2004;186-253.
Abnormal Laboratory Values: Secondary
Contributing Factors To Osteoporosis
• Testing included: Alk. Phos., Ca, Phos, PTH, 25OH Vitamin D, sPEP in 81 pts.
• 89% (72 of 81) with some abnormality
• 80% with abnormally low vitamin D level
• 62% (N=50) with vitamin D levels <20ng/mL
• Of these, 8 patients with unmeasurable level
• 13% with elevated PTH
• 13% with abnormal sPEP
Simonelli, et al, JBMR, 2004
Percent
Prevalence of Vitamin D Inadequacy
by Age Group
100
90
80
70
60
50
40
30
20
10
0
Age 50-79
(n=29)
Age 80+
(n=49)
N =78
<9
<15
<20
<25
<30
Cutoff points for Serum-25 OHD (ng/mL)
Management of Future Fracture Risk
Following Low-impact Fracture
• Fall risk
• Osteoporosis risk
• Historical risk factors/height measure
• Bone mineral density
• Metabolic evaluation
• Management/treatment
• Nutritional supplements
• Prescription medication
First LineTreatment Options Post
Fracture
• *Anabolic therapy
• Teriparatide
• Anti-catabolic therapy
•
•
•
•
Alendronate
Risedronate
Zolendronic Acid
Denosumab
*Available data indicate there is likely an important role for teriparatide in promoting fracture healing in
selected patients, but more clinical trial data are needed. Expert Opin Biol Ther. 2015 Jan;15(1):119-29.
doi: 10.1517/14712598.2015.977249. Epub 2014 Nov 3.
The effect of parathyroid hormone and teriparatide on fracture healing. Campbell EJ, Campbell GM,
Hanley DA.
Has The Treatment Gap Narrowed?
Effect of OP Treatment on Hip Fracture
Patients
• 520 patients
• OP treatment post hip fracture was predictor
of:
• functional recovery,(p values <.05),
• re-fracture rate (p 0.028)
• quality of live (p values <0.05).
• In this study OP treatment did not affect postfracture mortality rates.
Makridis, et al. The Effect of Osteoporotic Treatment on the Functional Outcome, refracture rate, quality of life and mortality In patient with hip fractures: Prospective functional
and clinical outcome study on 520 patients. Injury 2014 Dec11.031.
Osteoporosis in Fracture Patients:
Tomorrow’s Challenges
• Recognize the fracture patient as patient at
highest risk and most likely to benefit from
therapy
• Recognize importance of ‘secondary’ OP
• Recognize and treat vitamin D deficiency in elderly
• Improve physician acceptance of bone density
testing and drug therapy following acute FX
Download