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