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Objectives. Osteoporosis a major public health threat. Bone-Up on Osteoporosis Update 2011

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Bone-Up on Osteoporosis—

Update 2011

3/30/11

Kristine Olson, MS, APN, FNP-BC

Nurse Practitioner Mercer Bucks Hematology

Oncology

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Objectives

Review risk factors and screening for osteoporosis.

Describe the impact of osteoporotic fractures on patients and society.

Explain prevention and non- pharmacologic treatment of osteoporosis.

Describe pharmacologic treatment of osteoporosis.

Osteoporosis—a major public health threat

Estimated 52.4 million Americans at risk (all #s are estimates)

12 million w/osteoporosis

40.4 million w/low bone mass

Equals 55% of those age 50+

80 % w/dx are women (9.1 million)

20% w/dx are men (2.8 million)

All ethnic groups have significant risk

(2)

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Osteoporosis Prevalence Race and Ethnicity

20% non-Hispanic Caucasian &

Asian women > age 50 have osteoporosis

52% low bone mass

10% Hispanic women > age 50

49% low bone mass

5% non-Hispanic black women >

age 50

35 % low bone mass

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Osteoporosis Prevalence Race and Ethnicity—Men

7% non-Hispanic Caucasian &

Asian men > age 50

35% low bone mass

3% Hispanic men > age 50

23% low bone mass

4% non-Hispanic black men > age 50

19% low bone mass

National Osteoporosis Foundation

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Osteoporotic Fracture Incidence

In 2005, osteoporosis responsible for >2 million fractures

~297,000 hip fractures

~547,000 vertebral fractures

~397,000 wrist fractures

~765,000 fractures at other sites

Burge R, et al. Incidence and Economic Burden of Osteoporosis-Related Fractures in the United States 2005-2025. JBMR. 2007; 22:465-475.

(3)

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Significance of

Osteoporosis in Women

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Cost of Osteoporosis

Osteoporotic fractures account for

~$17 billion in direct medical costs

Projected to be over $25 million by 2025

>400,000 hospital admissions

~2.5 million “physician” visits

>180,000 nursing home admissions

Osteoporosis—NIH Definition

A skeletal disorder characterized by compromised bone strength predisposing to an increased risk of fracture.

Bone strength = Bone quality including bone density, architecture and bone turnover

NIH Consensus Conference, 2000

(4)

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What is Osteoporosis

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Micrograph: Normal vs. Osteoporotic Bone

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Vertebral Compression

Fractures

(5)

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2004 Surgeon General’s Report—Key Points

Many Americans are at significant risk for bone loss and osteoporosis.

Great improvements have been made in the bone health of Americans.

More can be done by applying what is known about early prevention, assessment, diagnosis and treatment.

US Dept of Health and Human Services, Bone Health and Osteoporosis: A Report of the Surgeon General, Office of the Surgeon General, 2004

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2004 Surgeon General’s Report

Studies showed a failure to diagnose and treat osteoporosis, even in elderly patients who have suffered a fracture.

A gap between what is known and its application in the community remains large and needs to be closed.

Risk Factors

Low bone density (osteopenia)

Age

Hx prior fracture

Parental hx of hip fx

Race

Small frame

Low estrogen or testosterone

Lifestyle factors

Low calcium intake, low activity, low BMI

Vitamin D insufficiency

Excess caffeine,

> 3EtOH/day, tobacco, NaCl

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Risk Factors—

Secondary Osteoporosis

Genetic factors

Parental hx, cystic fibrosis, Marfan

Endocrine disorders

Hypogonadal states

GI disorders .

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Risk Factors—Secondary Osteoporosis

Hematologic disorders

Rheumatic & autoimmune diseases

Miscellaneous conditions

alcoholism, COPD, ESRD, CHF, etc.

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Medications Associated with Decreased Bone Mass in Adults

Anticoagulants (heparin)

Anticonvulsants

Aromatase inhibitors

Barbiturates

Cancer drugs

Cyclosporin A

Glucocorticoids—oral & high-dose inhaled

(7)

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Medications Associated with Decreased Bone Mass in Adults

Gonadotropin-releasing hormone agonists

Lithium

Depot medroxyprogesterone acetate

Probable:

PPIs (proton pump inhibitors)

SSRIs (selective serotonin reuptake inhibitors)

TZDs (thiazolidinediones)

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Glucocorticoid-Induced Osteoporosis

Most common form of 2ndary osteoporosis

Long-term use oral > 5 mg prednisone/day for 3 mo.

High dose inhaled steroids

> 800 mcg/24 h

ACR recommends calcium 1000-1500 mg/day, Vit D 800 IU/day,

bisphosphonate if BMD T-score <-1.0

Caution w/premenopausal women

Risk Factors for Falls

Environmental

Medical

Neuro & musculoskeletal

(8)

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Bone Mineral Density Testing

DXA (DEXA) of hip & spine preferred method

Peripheral machines check BMD at forearm, heel or finger

Use x-ray or U/S

Hip BMD is single best predictor of hip fx risk

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Defining osteoporosis by BMD

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WHO Osteoporosis

Guidelines

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Pharmacologic Treatment

Antiresorptive Medications

Bisphosphonates

Calcitonin

Estrogen

Estrogen agonists/antagonists

Bone forming (anabolic) Medications

Parathyroid hormone—teriparatide

New: human monoclonal AB to RANK- ligand—denosumab (Prolia)

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Bone Remodeling

Preventive maintenance

Osteoclasts remove old bone

Osteoblasts replace new bone

Imbalance of the 2 processes

Peak bone mass reached at ages 18—25

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Compact (Cortical) Bone &

Cancellous (Trabecular) Bone

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Bisphosphonates

Alendronate—oral

Fosamax, Fosamax Plus D

Ibandronate—oral

Boniva

Risedronate—oral

Actonel

Actonel with Calcium

Atelvia

Zoledronic acid—IV

Reclast

(11)

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Alendronate

Fosamax or Fosamax Plus D, generic

FDA approved for prevention & tx of postmenopausal osteoporosis

Men w/osteoporosis

Men & women taking glucocorticoid

Prevention = 5 mg daily or 35 mg weekly

Treatment = 10 mg daily or 70 mg weekly

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Ibandronate: Boniva

FDA approved for tx of postmenopausal osteoporosis

Oral forms also approved for prevention: 2.5 mg tab daily or 150 mg Q mo.

3 mg IV Q 3 mo.

Reduces incidence of vertebral fx by 50% over 3 years

Risedronate: Actonel

Actonel or Actonel with Calcium

FDA-approved for prevention & tx of postmenopausal osteoporosis, also men

& women on glucocorticoids

Approved for men w/ osteoporosis

Multiple dose forms:

5 mg daily tabs, 35 mg Q wk, 35 mg Q wk w/6 tabs of 500 mg CaCO3, 75 mg 2 days/mo., 150 mg Q mo.

Reduces verteb fx 41-49%, non-verteb 36% over 3 yrs., in pt. w/prior v. fx

(12)

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Zoledronic acid: Reclast

IV: 5 mg over at least 15 min. Q yr

FDA-approved for tx of postmenopausal osteoporosis

Approved for prevention of new fx in pt w/recent low-trauma hip fx

Reduces incidence of verteb fx 70%, non-verteb fx 25% over 3 yrs

Consider pre-tx w/acetaminophen

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Side Effects of Bisphosphonates

GI problems

Esoph inflam

Difficulty swallowing

Gastric ulcer

Bone/joint/muscle pain

Very rare jaw osteonecrosis

A fib--Zometa

Visual disturbances

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Administration of Bisphosphonates

PO forms poorly absorbed

Empty stomach, 8 oz. H2O only

Except delayed release risedronate

Atelvia 35 mg once weekly after breakfast

Then NPO 30+ min. except 60+ min. w/

Boniva

Sit/stand 30 to 60 min. + after

Check creatinine

(13)

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Calcitonin

Miacalcin or Fortical

FDA-approved for tx of

osteoporosis in women at least 5 yrs postmenopausal

Nasal spray 200 IU daily, or SQ

Effect of fx risk not stated in Rx Info

Considered safe.. rhinitis, rare epistaxis

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Estrogen/Hormone Therapy

Multiple brands/formulations

FDA-approved for prevention of osteoporosis, relief of vasomotor symptoms & vulvovag atrophy in menopause

WHI: 5 yrs of HT (Prempro) reduced risk verteb fx 34%, other 23%

WHI: increase risk MI, stroke, breast Ca, PE, DVT in 5 yrs of HT

ET arm, no inc. breast Ca in 7 yrs

Estrogen

Agonist/Antagonist

Raloxifene: Evista (SERM) 60mg PO daily

FDA-approved for prevention &

treatment osteoporosis in post- menopausal women

Reduces risk of verteb fx 30% in pt w/prior v fx, 55% in pt w/o over 3 yrs

Indicated for reducing risk of invasive breast Ca in postmenop w/osteoporosis

Increased risk DVT, no dec. CHD, + hot flashes

(14)

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Parathyroid Hormone

PTH (1-34), teriparatide, Forteo

FDA-approved for tx of

osteoporosis in postmenopausal women at high risk for fx.

Men w/primary or hypogonadal osteoporosis w/high fx risk

Anabolic (bone-building)

20 micrograms SQ daily, max 2 yrs

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Parathyroid Hormone:

Forteo

Increased osteosarcoma in rats

Therefore, contraindicated/black box warning:

Paget’s disease of bone, alk phos

Prior XRT of skeleton

Bone mets

Hypercalcemia

Skeletal malignancy

Follow w/ bisphosphonate

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Denosumab (Prolia)

Antiresorptive with different pathway than bisphosphonates

Human monoclonal antibody

Inhibits osteoclast formation & function by binding to RANK ligand

SubQ injection: 60 mg/mL given Q 6 months

Indicated for postmenopausal women w/high risk for fx

Or intolerant of other rx

(15)

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Calcium & Vitamin D

All adults require at least 1200 mg calcium/day via food and

supplements

People over age 50 average 600 to 700 mg Ca++ daily!

NOF advises 800 to 1000 IU Vit. D daily to = serum 24(OH)D of 30 ng/mL or higher

Vit D3, cholecalciferol, preferred

FRAX Tool

WHO Fracture Risk Assessment Tool:

www.NOF.org

www.shef.ac.uk/FRAX

Plug in 12 questions: Age, sex, weight, height, previous fx, parent hip fx, current smoking, glucocorticoid use, RA, secondary osteoporosis, EtOH 3 or + units/d, femoral neck BMD, type of DXA

Calculates 10 yr probability of hip fx & 10 yr probability major osteoporotic fx (vertebral, hip, forearm or humerus) Economic model

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FRAX Tool—1 of US versions

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Summary

Osteoporosis affects millions of Americans, #s will increase

Costs, in $ and morbidity & mortality, are very high

$17 billion in 2005

About 400K hosp admissions

24% of hip fx pts die in yr after fx

Prevention and treatment can be effective! …also falls prevention!

Don’t forget lifestyle counseling

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Thank You!

Questions?

References

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