OSTEOPOROSIS: AN OPPORTUNITY OR OBLIGATION Debra L. Sietsema, PhD, RN Director, Bone Health Clinical Operations October 5, 2016 OTA NP/PA Course 1
Osteoporosis Definition A skeletal disorder characterized by compromised bone strength predisposing a person to an increased risk of fracture Normal Bone Osteoporotic Bone NIH Consensus Development Panel on Osteoporosis. JAMA. 2001;285:785-795 2
WHO Classification 3
Fragility Fracture Resulting from a: Fall from a standing height Spontaneous fracture Establishes osteoporosis diagnosis regardless of DXA results Siris, et al. The clinical diagnosis of osteoporosis. Ost Int. 2014; 25:1439-1443. 4
Shifting the Osteoporosis Paradigm: Bone Strength Bone Density abmd = g/cm 2 vbmd = g/cm 3 Bone Quality Bone Strength Mineralization Bone remodeling Damage accumulation Trabecular connectivity Architecture NIH Consensus Development Panel on Osteoporosis. JAMA. 2001;285:785-795. 5
What s the problem? 6
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Prevalence of Osteoporosis and Low Bone Mass Americans Age 50 and Above Affected by Osteoporosis/Low Bone Mass, 2010 to 2030 (projected) 80 Osteoporosis Prevalence of Osteoporosis and Low Bone Mass 54 million of 99 million Americans age 50+ (2010) 17% of the ENTIRE U.S. POPULATION (2010) Millions 70 60 50 40 30 20 10 Wright NC, et al. JBMR doi:10.1002/jbmr2269 0 2010 2030 +27% change from 2010 to 2030 Low Bone Mass Osteoporosis 8
Hospitalization Burden for Osteoporotic Fractures and Other Serious Diseases in Older US Women Figure 1. Percent of hospitalizations* for osteoporotic fractures and other serious diseases combined, 2000 2011 *Principal diagnosis codes were used to define the outcomes. Singer AJ, et al. Osteoporosis International. 25(4) suppl:503-522;2014. Singer AJ, et al. Mayo Clinic Proceedings 2015 90, 53-62 9
Incidence Rates for Vertebral, Wrist, and Hip Fractures in Women After Age 50 40 Vertebral 30 Annual Incidence per 1000 Women 20 10 Wrist Hip 0 50 60 70 80 Age (Years) Wasnich RD. In: Favus MJ, ed. Primer on the Metabolic Bone Diseases and Disorders of Mineral Metabolism. 4th ed. Philadelphia, PA: Lippincott; 1999:257-259. 10
Incidence Rates for Vertebral, Wrist, and Hip Fractures in Women After Age 50 40 Vertebral Annual Incidence per 1000 Women 30 20 10 0 Youngest Baby Boomers Largest Baby Boomer Group Wrist Hip 50 60 70 80 Age (Years) Oldest Baby Boomers Wasnich RD. In: Favus MJ, ed. Primer on the Metabolic Bone Diseases and Disorders of Mineral Metabolism. 4th ed. Philadelphia, PA: Lippincott; 1999:257-259. 2015 11
Incidence Rates for Vertebral, Wrist, and Hip Fractures in Women After Age 50 40 Annual Incidence per 1000 Women 30 20 10 2030 Youngest Baby Boomers Wrist Largest Baby Boomer Group Vertebral Hip Oldest Baby Boomers 50 60 70 80 Age (Years) Wasnich RD. In: Favus MJ, ed. Primer on the Metabolic Bone Diseases and Disorders of Mineral Metabolism. 4th ed. Philadelphia, PA: Lippincott; 1999:257-259. 12
Distal Radial Fractures The lifetime risk of sustaining a distal radial fracture is about 16% for white women. By age 70, about 20% of women have had at least one distal radial fracture. 13
Vertebral fractures 35 to 50% of all women over fifty have at least one vertebral fracture. Between 30-65% are undiagnosed 1 3X risk 3 9X risk Siris, et al. Enhanced prediction of fracture risk combining vertebral fracture status and BMD. Ost Int. 2007;18:761-770. 14
Proximal Femoral Fractures A 50-year-old white woman is estimated to have a 17.5% lifetime risk of fracture of the proximal femur. 15
Proximal Femoral Fractures Incidence increases each decade for all populations. Highest incidence is found among men and women ages 80 or older. 16
1 out of 2 Women will have an osteoporotic fracture 17
1 in 4 Men will have an osteoporotic fx More likely to have an osteoporotic fracture than to get prostate cancer 80,000 men have a hip fracture annually Men are more likely to die within a year after hip fracture 18
Importance to Orthopedics Unique opportunity sentinel event Reduce subsequent fractures Enhance fracture healing Comprehensive, excellent care 19
Osteoporotic Disasters 20
Osteoporotic Disasters 21
Osteoporotic Disasters 22
Osteoporotic Disasters 23
Osteoporotic Disasters 24
Osteoporotic Disasters 25
Osteoporotic Disasters 26
Advances to Treat these Fractures Locking technology Cephalomedullary nails Ceramics Osteobiologics 27
Identified Treatment Gap - NCQA HEDIS Measure % Compliance Beta-blocker after a heart attack 91.4% Breast cancer screening 82.7% Colorectal cancer screening 73.8% Osteoporosis management after a fracture 20.7% NCQA Medical Evaluation 2013- HMO Statistics 28
Optimal Management of Care Diagnosis of fragility fracture General fracture management Rehabilitation Secondary prevention: Prevent subsequent fx Identify, assess, treat, & evaluate underlying disease Teach & counsel re: condition & lifestyle behaviors Coordinated, comprehensive manner Ganda. Models of care. Ost Int. 2012 29
Fragility Fracture? Injury Pattern Mechanism of injury Low trauma Fall from a standing ht or less Fx that occurred during activity Did others involved fx? Risk Assessment Risk factors for: 1 & 2 osteoporosis Fracture Fall No symptoms of low bone mass until fracture. May be 1 st indication of osteoporosis! 30
Physical Findings Clinical Presentation indicating increased fracture risk Impaired ambulation Muscle weakness Impaired balance Reduced vision Macular Degeneration Glaucoma Bifocals Orthostatic hypotension Clinical presentation indicating signs of prior fractures Loss of height Kyphosis Chest deformity Protuberant abdomen Rib-pelvis overlap 31
Key Risk Factors for Fractures (RR 2) Age BMD Prior fragility fx Family hx of fragility fx Kanis. Ost Int. 2005; 16 32
Causes of Secondary Osteoporosis Endocrine Disorders affecting bone metabolism Menopause < age 45 Hypercalcuria with or without renal stones Hypogonadism Hyperparathyroidism Hyperthyroidism Cushing s syndrome Diabetes (types 1 and 2) Acromegaly Osteogenesis Imperfecta 33
Causes of Secondary Osteoporosis Drugs affecting bone quality Excess/length of time on glucocorticoids Excess thyroid hormones Anticoagulants (heparin) GnRH agonists Anticonvulsants Aromatase inhibitors Thiazolidinediones Opiates Cyclosporine Chemotherapy Alcohol Loop diuretics PPI long term use 34
Secondary Causes of Osteoporosis GI Tract Disorders Malabsorption Gastrectomy Inflammatory bowel disease Celiac disease Intestinal bypass surgery Primary biliary cirrhosis Pancreatic insufficiency Hepatitis B, C Bone Marrow Based Disorders Multiple myeloma Hemolytic anemia, hemoglobinopathies Myelo-and lymphoproliferative disorders Skeletal metastases (diffuse or localized) Gaucher s disease Mastocytosis 35
Secondary Causes of Osteoporosis Inflammatory Disorders RA SLE Ankylosing spondylitis Polymalgia rheumatica Vasculitis Other Propensity to fall Immobilization COPD Chronic renal failure AIDS/HIV Organ transplantation Anorexia / Bulemia Malignancy 36
Other Significant Risk Factors Vitamin D insufficiency History of missed menses/estrogen deficiency Smoking Excessive alcohol intake Sedentary lifestyle Environmental risks for fall Collagen deficiency Hypermobility / flexibility 37
Clinical Approach to Managing Osteoporosis Assessment Detailed osteoporosis risk factor hx r/t fx & falls Physical exam Diagnostic studies 10-year probability of fx (FRAX) Ultimate Goal Prevent fractures Plan Mutual plan 38
Clinical Approach to Managing Osteoporosis Implement Nonmedical interventions Modify risk factors PT/OT Psychosocial support Supplements Prescriptive therapies Evaluate Lifestyle changes Rx Compliance Diagnostic studies Vertebral imaging Fracture occurrence 39
Suggested Laboratory Tests Complete blood count Serum chemistry studies Serum 25-hydroxyvitamin D ipth Bone turnover markers CTX & P1NP TSH Testosterone 1, 25 Vitamin D 24 hr urine for calcium Phosphorus Watts NB, et al. AACE Medical Guidelines for Clinical Practice for the diagnosis and treatment of postmenopausal osteoporosis Endocr Pract. 2010;16(suppl 3):1-37. Cosman, et al. Clinician s guide to prevention and treatment of osteoporosis. Ost Int. 2015; 26:2045-2047. 40
Other Laboratory Tests Lab Test Erythrocyte sedimentation rate Urinary cortisol or other tests Serum protein electrophoresis (SPEP) and light chains Tissue transglutaminase antibodies Purpose Malignancy or inflammatory disease Adrenal hypersecretion Myeloma Celiac disease 41
Pharmacological Treatment Guidelines Postmenopausal women and men age 50 and older presenting with one of the following: Fracture T-Score - A vertebral or hip fracture - T-score -2.5 at the femoral neck, total hip, or lumbar spine by DXA FRAX - 10-year probability of a major fracture 20% - 10-year probability of a hip fracture 3% Cosman, et al. Clinician s guide to prevention and treatment of osteoporosis. Ost Int. 2015; 26:2045-2047. 42
Treatment Guidelines: Post-menopausal Women And Men 50 Assess Risk Factors and Measure BMD if Patient Has Risk Factors T-score between -1.0 and -2.5 Hip or Vertebral Fractures or T-score -2.5 (Spine, Femoral Neck or Total Hip) FRAX 10-year Probability of Hip Fracture 3% or Probability of All Major Fractures 20% www.shef.ac.uk/frax 43
Medications for Osteoporosis Inhibit Bone Resorption Bisphosphonates Alendronate (Fosamax) Risedronate (Actonel, Atelvia) Ibandronate (Boniva) Zolendronate (Reclast) Monoclonal antibody Denosumab (Prolia) SERM Raloxifene (Evista) Other Estrogen (various) Calcitonin(Miacalcin, Fortical) Stimulate Bone Formation Anabolic Teriparatide (Forteo) 44
FDA Approved Medications: Evidence for Fracture Reduction Medication BMD Vertebral Fx Nonvertebral Fx Hip Fx Alendronate X X * X Risedronate XX X X * Ibandronate XX X No effect No effect Zoledronic acid XX X X X Denosumab XXX X X X Raloxifene X X No effect X Teriparatide XXX X X X * Evidence for effect, but not FDA approved indication 45
Challenges of Osteoporosis Rx Success = absence of fracture $$$ Other costs of treatment: Nuisance of taking another medication Reminder of illness/condition Worry about consequences of therapy Adverse effects of treatment 46
Atypical Femoral Fractures With every 50 hip fractures prevented with bisphosphonates, 500/1000 women will suffer a fracture without treatment 1 atypical femoral fracture may result. Out of 1,000 people on bisphosphonates for 5 years, < 1 will have an atypical fx (.16/1000) & < 1 will have osteonecrosis of the jaw (.01/1000).
Adherence & Persistence Patient Pain & Disability Teachable Moment Begin regimen early Purposes Enhance fracture healing Prevent subsequent fractures Treatment Team Fracture liaison service (FLS) Recognizable face Consistent message Coordinated or Separate appointments Education, counseling and guidance Assure follow-up 48
Treatment: Summary Safe and effective therapies are available Anti-remodeling (antiresorptive) agents Prevent bone loss and preserve architecture Reduce the risk of vertebral fractures (all agents) Alendronate, risedronate, zoledronic acid and denosumab reduce the risk of nonvertebral and hip fractures Bone building (anabolic) agent: (teriparatide) Increases bone density and size Improves quality of bone Reduces the risk of vertebral and nonvertebral fractures New Drugs: Abaloparatide (anticipated Q2 2017): anabolic Romosozumab (anticipated late 2017): antisclerostin antibody Patient factors determine the most appropriate drug to use 49
Treatment: Summary, continued BMD Change Doesn t Fully Predict the Reduction in Fracture Risk Fracture Risk Anti-remodeling treatment decreases fracture risk more rapidly and to a larger extent than one would predict from the relatively small changes in BMD Fracture protection can be observed in the absence of a significant change in BMD Fracture protection persists even when the BMD reaches a plateau BMD stability does not mean nonresponse 50
Treatment: Summary, continued The fracture risk is determined by the complex interactions among bone mineral density (BMD), bone quality, and trauma Contemporary pharmacologic treatments will typically reduce vertebral fracture risk by 30%-70%, with smaller reductions in non-vertebral fracture risk No pharmacologic treatment is likely to reduce fracture risk to zero, in part because of the inability to eliminate trauma There are a number of promising pharmacologic agents with most of the emphasis to be placed on the development of novel anabolic agents 51
Integrate Own The Bone Program: Ten Important Measures to Achieve Success NUTRITION COUNSELING* 1. Calcium supplementation 2. Vitamin D supplementation PHYSICAL ACTIVITY COUNSELING* 3. Exercise, especially weight-bearing and muscle strengthening 4. Fall prevention education LIFESTYLE COUNSELING* 5. Smoking cessation 6. Limiting excessive alcohol intake PHARMACOLOGY* 7. Pharmacology for the treatment of osteoporosis TESTING* 8. DXA to test bone mineral density COMMUNICATION 9. Physician referral letter 10. Follow-up notes and educational materials provided to patient *Unless contraindicated. Measures listed here are consistent with recommendations from the National Osteoporosis Foundation, the Centers for Medicare & Medicaid Services, the Joint Commission, the World Health Organization, and the American Medical Association. 52
Rewards of Osteoporosis Treatment Reduction in the risk of fracture Reduction in pain and disability Preservation of independence Reduction in height loss Positive effect on mortality (?) Positive effect of being proactive Positive effect on BMD Decrease in subsequent fractures Unique benefit to community 53
Bone Health Across the Lifespan 54
Keep Life in Motion! 55
Questions? 56