Captured Fracture: ManagementChristine Simonelli, MDDirector, 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

Ross PD et al. Calcif Tissue Int 1993;5:S135

Wasnich R. Am J Med. 1993;95(Suppl 5A):6S-10S.

Skeletal Fragility: Fractures Predict Fractures

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

Karlsson M, Nilsson JA, et al. Bone 1996; 18:19-22Garnero P, et al. EPIDOS Prospective Study. JBMR 1996; 11:1531-8

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 low-impact 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

Per

cent

‡ More likely to be diagnosed if prior fx p=0.008

‡

*NS from Adm

(Calcium ≥1000mg/d)

One-year Follow-up: Patients Admitted With Low-Impact

FractureN=227

Per

cent

Estrogen 24; alendronate 12; calcitonin 14; combination 8

p<.001 p=NS

D/C 1 yr. F/U

Simonelli C, Morancey J, et al. J Gen Int Med 2003,Vol.18;17-22

Quality of Life Measures at One Year

Per

cent

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

Follow-up telephone contact at 6 months and one year

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

Comparison of Pilot With Education Intervention: OP

Awareness and Ca use

Per

cent

‡p<.001 *p=.01

‡‡‡

Comparison of Pilot With Education Intervention: Osteoporosis Medication

Per

cent

Res

pond

ing

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

Who is Responsible For Addressing OP Risk in The FX Patient?

Per

cent

Res

pond

ing

Simonelli C, Killeen K, Swanson,L, et al. Mayo Clinic Proc, 2002

What Are Factors Limiting Treatment of OP in The Fracture

Patient?

Per

cent

Res

pond

ing

Physicians Report Being More Likely To Treat:

Per

cent

Res

pond

ing

How Should We Increase Number of Fracture Patients Treated For

OP?

Per

cent

Res

pond

ing

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

EducationN= 184

Education and Consult N=83

% Female 76 54*% Prior FX 49 58

% Hip FX 53 95*

% ≥70 yrs 68 75

Prior BMD 9 21*

All statistics done using logistic regression correcting for differences in baseline values

*p<.01

Phase III: Effectiveness of Nurse Practitioner Consultation At

Discharge

OP in chart CA >1000mg Vit D >400IU OP med0

20

40

60

80

100

26

17

0

17

40

49

28

14

100

70

61

30

Per

cent

*p<.001 p<.003 p<.001 p<.002

‡

Baseline DataEducation NP Consult

Phase III: Effectiveness of Nurse Practitioner : One Year Follow-up

Per

cent

*P<.02, baseline vs. educ. or consult p=NS‡ P =0.02, Consult vs education, correcting for age

80% Bisphosphonate16% Calcitonin4% Raloxifene

* ‡*

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

Fracture » A vertebral or hip fracture

T-score » T-score ≤ –2.5 at femoral neck or spine†

FRAX® Assessment(T-score between –1.0 and –2.5)

» WHO 10-year probability of any major osteoporotic fracture ≥ 20%

» WHO 10-year probability of a hip fracture ≥ 3%

Initiate pharmacologic therapy in men and postmenopausal women* in presence of:

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

Karlsson M, Nilsson JA, et al. Bone 1996; 18:19-22Garnero P, et al. EPIDOS Prospective Study. JBMR 1996; 11:1531-8

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 andTreatment 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, 25-

OH 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

Prevalence of Vitamin D Inadequacy by Age Group

N =78

Pe

rce

nt

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 post-fracture mortality rates.

Makridis, et al. The Effect of Osteoporotic Treatment on the Functional Outcome, re-fracture rate, quality of life and mortality In patient with hip fractures: Prospective functional and clinical outcome study on 520 patients. Injury 2014 Dec11.031.

• 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

Osteoporosis in Fracture Patients: Tomorrow’s Challenges