OSTEOPOROSIS: AN OPPORTUNITY OR OBLIGATION · 2018-05-08 · In: Favus MJ, ed. Primer on the Metabolic Bone Diseases and Disorders of Mineral Metabolism . 4th ed. Philadelphia, PA:

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© The CORE Institute. All rights reserved.

OSTEOPOROSIS: AN OPPORTUNITY OR OBLIGATION

Debra L. Sietsema, PhD, RN Director, Bone Health Clinical Operations

October 5, 2016 OTA NP/PA Course

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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

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WHO Classification

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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.

Presenter

Presentation Notes

Location of injuries

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Shifting the Osteoporosis Paradigm: Bone Strength

Bone Density

Bone Quality

Bone Strength

•Mineralization •Bone remodeling •Damage accumulation •Trabecular connectivity •Architecture

aBMD = g/cm2

vBMD = g/cm3

NIH Consensus Development Panel on Osteoporosis. JAMA. 2001;285:785-795.

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What’s the problem?

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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)

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2010 2030

Low Bone MassOsteoporosis

Mill

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54 million of 99 million Americans age 50+ (2010)

+27% change from 2010 to 2030

17% of the ENTIRE U.S. POPULATION (2010)

Osteoporosis Prevalence of Osteoporosis and Low Bone Mass

• Wright NC, et al. JBMR doi:10.1002/jbmr2269

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Figure 1. Percent of hospitalizations* for osteoporotic fractures and other serious diseases combined, 2000–2011

*Principal diagnosis codes were used to define the outcomes.

Hospitalization Burden for Osteoporotic Fractures and Other Serious Diseases in Older US Women

Singer AJ, et al. Osteoporosis International. 25(4) suppl:503-522;2014. Singer AJ, et al. Mayo Clinic Proceedings 2015 90, 53-62

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Presentation Notes

During the 12-year study period, there were 4.9 million hospitalizations for osteoporotic fractures (2.6 million for hip fractures, 70,025 for forearm fractures, 888,845 for spinal fractures, 407,544 for pelvic fractures, 295,565 for distal femur fractures, 173,925 for wrist fractures, and 421,164 for humerus fractures), 2.9 million for MI, 3.0 million for stroke, and 0.7 million for breast cancer. Osteoporotic fractures accounted for more than 40% of the hospitalizations in these 4 outcomes combined. When we restricted the analysis to women 75 years and older, osteoporotic fractures accounted for nearly 50% of the hospitalizations. The total number of hospitalizations for osteoporotic fractures increased over the 12-year study period, whereas these decreased for MI, stroke, and breast cancer. The increase in the number of hospitalizations was seen for fractures occurring at all anatomic locations except the hip.

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© The CORE Institute. All rights reserved. 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.

50 60 70 80

Vertebral

Hip

Wrist

Age (Years)

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Incidence Rates for Vertebral, Wrist, and Hip Fractures in Women After Age 50

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Presenter

Presentation Notes

The incidence of all osteoporotic fractures increases with age.1 Shortly after menopause, the incidence of wrist fracture begins to increase and continues to do so until the age of 65, when it plateaus. The incidence of hip fracture increases more slowly with age until later in life, after age 80, when the incidence begins to increase exponentially. Vertebral fracture, the most common fracture, occurs earlier after menopause than hip fracture, and continues to rise with age. Approximately 1.5 million osteoporotic fractures occur in the United States annually, comprised of 250,000 wrist fractures, 300,000 hip fractures, 700,000 vertebral fractures, and 250,000 fractures at other sites.2 Thus, most osteoporotic fractures are vertebral fractures. Wasnich RD: Primer on the Metabolic Bone Diseases and Metabolism. 4th edition, 1999 America’s Bone Health: The State of Osteoporosis and Low Bone Mass in � Our Nation. Washington, DC: National Osteoporosis Foundation; 2002: 1-12

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© The CORE Institute. All rights reserved. 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.

50 60 70 80

Vertebral

Hip

Wrist

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omen

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0 Old

est B

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Boom

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2015

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Presentation Notes


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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.

50 60 70 80

Vertebral

Hip

Wrist

Age (Years)

Annu

al In

cide

nce

per

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0 W

omen

40

30

20

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Old

est B

aby

Boom

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Larg

est B

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Boom

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roup

Youn

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2030

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Presentation Notes


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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.

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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.

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Proximal Femoral Fractures

A 50-year-old white woman is estimated to have a 17.5% lifetime risk of fracture of the proximal femur.

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Proximal Femoral Fractures

Incidence increases each decade for all populations. Highest incidence is found among men and women ages 80 or older.

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1 out of 2 Women will have an osteoporotic fracture

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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

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Importance to Orthopedics

Unique opportunity – sentinel event Reduce subsequent fractures Enhance fracture healing Comprehensive, excellent care

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Osteoporotic Disasters

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Advances to Treat these Fractures

Locking technology Cephalomedullary nails Ceramics Osteobiologics

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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

Identified Treatment Gap - NCQA

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Presentation Notes

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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

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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 1st indication of osteoporosis!

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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

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Key Risk Factors for Fractures (RR ≥ 2)

Age BMD Prior fragility fx Family hx of fragility fx

Kanis. Ost Int. 2005; 16

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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

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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

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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

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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

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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

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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

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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

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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.

Presenter

Presentation Notes

Main Points Before initiating drug therapy, the American Association of Clinical Endocrinologists (AACE) recommends several laboratory tests to rule out secondary bone loss All patients with osteoporosis may have the following tests1,2: Serum chemistry studies (ie, calcium, phosphorus, total protein, albumin, liver enzymes, alkaline phosphatase, creatinine, and electrolytes) Serum 25-hydroxyvitamin D level Parathyroid hormone (PTH) for possible primary or secondary hyperparathyroidism References Watts NB, Bilezikian JP, Camacho PM, et al. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the diagnosis and treatment of postmenopausal osteoporosis. Endocr Pract. 2010;16(suppl 3):1-37. National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Washington, DC: National Osteoporosis Foundation; 2013.

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Other Laboratory Tests

Lab Test Purpose Erythrocyte sedimentation rate

Malignancy or inflammatory disease

Urinary cortisol or other tests

Adrenal hypersecretion

Serum protein electrophoresis (SPEP) and light chains

Myeloma

Tissue transglutaminase antibodies

Celiac disease

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Pharmacological Treatment Guidelines

Postmenopausal women and men age 50 and older presenting with one of the following:

Fracture - A vertebral or hip fracture T-Score - 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.

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Assess Risk Factors and Measure BMD if Patient Has Risk Factors

T-score between -1.0 and -2.5

FRAX

10-year Probability of Hip Fracture ≥ 3%

or

Probability of All Major Fractures ≥ 20%

Hip or Vertebral Fractures

or

T-score ≤ -2.5 (Spine, Femoral Neck or Total Hip)

Treatment Guidelines: Post-menopausal Women And Men ≥50

www.shef.ac.uk/FRAX

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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)

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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

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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

Presenter

Presentation Notes

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Atypical Femoral Fractures With every 50 hip fractures prevented with bisphosphonates,

1 atypical femoral fracture may result. 500/1000 women will suffer a fracture without treatment

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).

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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

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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

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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”

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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

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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.

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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

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Presentation Notes

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Bone Health Across the Lifespan

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Keep Life in Motion!

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Questions?

Documents

OSTEOPOROSIS: AN OPPORTUNITY OR OBLIGATION · 2018-05-08 · In: Favus MJ, ed. Primer on the Metabolic Bone Diseases and Disorders of Mineral Metabolism . 4th ed. Philadelphia, PA: