6--PCE Nashville Osteoporosis Knudtson

7/29/2019 6--PCE Nashville Osteoporosis Knudtson

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Osteoporosis Update:

Prevention, Diagnosis,

and TreatmentMary D. Knudtson, DNSc, NP

Clinical Professor

Department of Family MedicineUniversity of California, Irvine

Irvine, California


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Faculty Disclosure

Dr Knudtson: consultant/speakers bureau:

Procter & Gamble


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How confident are you addressing

modifiable risk factors for osteoporosis

with your patients?

1 2 3

32%

6%

62%

Use your keypad to vote now!

1. Very confident

2. Somewhat

confident

3. Not at all confident


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Learning Objectives

Assess the risk factors associated with osteoporosis

Manage osteoporosis in the context of comorbidities

Evaluate nonpharmacologic preventive approaches

as well as the efficacy and safety of pharmacologicmanagement


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Bone density=grams of mineral/area, volumeBone quality=architecture, turnover, damage

accumulation, mineralization

Bone strength =density + quality

SD = standard deviation; WHO = World Health Organization.

National Osteoporosis Foundation. Clinicians Guide to Prevention and Treatment of Osteoporosis. Available at:

www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 22, 2008; NIH Consensus Statement. 2000;17:1-45

Osteoporosis Defined

Osteoporosis, primary or secondary, is characterized

by compromised bone strength predisposing to an

increased risk of fracture

Osteoporosis = bone mineral density (BMD) 2.5 SD

below young normal mean at hip or spine [WHO]
http://www.nof.org/professionals/Clinicians_Guide.htmhttp://www.nof.org/professionals/Clinicians_Guide.htmhttp://www.who.int/chp/topics/Osteoporosis.pdf.%20Accessed%20041008


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Prevalence of Osteoporosis*

Osteoporosis is a major health threat in the United States 10 million Americans have osteoporosis, 34 million are at risk Osteoporosis disproportionately affects Caucasian and Asian

women; other races/ethnicities are also significantly affected Under-recognized problem in men

In men, involvement of all races and ethnicities is significant

In the United States, women and men aged 50 years 55% have low bone mass 8 million women and 2 million men have osteoporosis 1 of 2 white women, 1 of 5 men will suffer an osteoporosis-

related fracture Asian Americans with osteoporosis have same fracture

risk as white persons

Ebeling PR. N Engl J Med. 2008;358:1474-1482; National Osteoporosis Foundation. Clinicians Guide to

Prevention and Treatment of Osteoporosis. Available at: www.nof.org/professionals/Clinicians_Guide.htm.

Accessed April 22, 2008.

*Estimates based on 2000 census data.
http://www.nof.org/professionals/Clinicians_Guide.htmhttp://www.nof.org/professionals/Clinicians_Guide.htm


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Which of the following best characterizes

the burden of osteoporosis?

1 2 3 4

72%

2%

20%

6%


MI = myocardial infarction.

1. Osteoporotic fractures aremore common than MI,stroke, and breast cancercombined

2. Only MIs are more prevalent

than osteoporotic fractures3. Incidence of osteoporotic

fractures is equal to thatof MIs

4. None of the above


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American Cancer Society. Cancer Facts and Figures: 2003. Available at:

www.cancer.org/downloads/STT/CAFF2003PWSecured.pdf. Accessed April 15, 2008; American Heart Association.

Heart and Stroke Statistics: 2003 Update. Available at:

www.americanheart.org/downloadable/heart/10590179711482003HDSStatsBookREV7-03.pdf. Accessed April 15, 2008;

Riggs BL, Melton LJ III. Bone. 1995;17(5 Suppl):505S-511S.

*Annual incidence all ages; annual estimate women 29+; **annual estimate women 30+.

Osteoporotic Fractures Are More Common Than

MI, Stroke, and Breast Cancer Combined

1,500,000*

0

500,000

1,000,000

1,500,000

2,000,000

Osteoporotic

Fractures

513,000

MI

228,000**

Stroke

184,300

Breast Cancer

750,000vertebral

250,000other sites

250,000forearm

250,000hip

Annualincidence

ofComm

onDiseases
http://www.cancer.org/downloads/STT/CAFF2003PWSecured.pdfhttp://www.americanheart.org/downloadable/heart/10590179711482003HDSStatsBookREV7-03.pdf.%20Accessed%20April%2015http://www.americanheart.org/downloadable/heart/10590179711482003HDSStatsBookREV7-03.pdf.%20Accessed%20April%2015http://www.americanheart.org/downloadable/heart/10590179711482003HDSStatsBookREV7-03.pdf.%20Accessed%20April%2015http://www.americanheart.org/downloadable/heart/10590179711482003HDSStatsBookREV7-03.pdf.%20Accessed%20April%2015http://www.cancer.org/downloads/STT/CAFF2003PWSecured.pdf


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Which of the following is a common cause

of secondary osteoporosis?

1 2 3 4

10%4%

81%

5%Use your keypad to vote now!

1. Proton pump inhibitors(PPIs)

2. Treatment for ulcerativecolitis

3. Glucocorticoids4. TNF- receptor blockers

and IL-1 receptorantagonists for the treatmentof rheumatoid arthritis


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Factors Contributing to Secondary

Osteoporosis

LifestyleLow calcium intake, high caffeine intake, excessive alcohol

consumption, smoking, immobilization

Endocrine disorders Hyperthyroid, hyperparathyroid, adrenal insufficiency,Cushings syndrome, diabetes

Hypogonadal states Androgen insensitivity, anorexia/bulimia, athleticamenorrhea, hyperprolactinemia, panhypopituitarism

GI disorders Gastrectomy, GI bypass, celiac disease, malabsorption,

inflammatory bowel disease

Hematologic diseases Hemophilia, rheumatic and autoimmune conditions, sickle

cell, thalassemia, lymphoma, myeloma

Miscellaneous conditions Alcoholism, amyloidosis, CHF, epilepsy, ESRD, MS, prior

fracture as adult, epilepsy, depression

Medications Glucocorticoids, anticoagulants, anticonvulsants, aromatase

inhibitors, cyclosporine, lithium, cancer chemotherapy,

depomedroxyprogesterone

CHF = congestive heart failure; ESRD = end-stage renal disease; GI = gastrointestinal; MS = multiple sclerosis.AACE Osteoporosis Task Force. Endocr Prac. 2001;7:293-312; National Osteoporosis Foundation. Clinicians Guide to Prevention

and Treatment of Osteoporosis. Available at: www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 30, 2008.


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Glucocorticoid Use and Fracture Risk

1.171.36

1.64

1.1 1.04 1.190.99

1.77

2.27

1.55

2.59

5.18

0

1

2

3

4

5

6

Low Dose Medium Dose High Dose

All nonvertebral

Forearm

Hip

Vertebral

n = 2192 531 236 191 2486 526 494 440 1665 273 328 400

RelativeRisk

ofFracture

ComparedW

ithControl

Van Staa TP, et al. J Bone Miner Res. 2000;15:993-1000.

(7.5 mg/d)


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Pathophysiology of Osteoporosis

Osteoid Mineralization

Bone

RestingActivationResorption

BoneOsteoclasts

Bone Remodeling

ReversalFormation

BoneBone

Osteoblasts


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Pathophysiology of Osteoporosis

Trauma

Low bonemass/

impairedbone

quality

Inadequatepeak bone

mass

Earlymenopausal

bone loss

Decreasein bone

mass/bone

quality

Calcium/vitamin Ddeficiency

Otherfactors

Fractures


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20 years

50 years

80 years

Changes in Trabecular Architecture

Decrease in trabecular thickness, more

pronounced for non load-bearing

horizontal trabeculae

Decrease in connections between

horizontal trabeculae Decrease in trabecular strength and

increased susceptibility to fracture

Mosekilde L. Calcified Tissue Inter. 1993;53(Suppl 1):S121-S126.


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Fracture Patterns By Age

Riggs B. N Engl J Med1986;314:1676.

Age (years)

AnnualFrac

ture

Incidence/10

0,0

00

0

1000

2000

3000

4000

35 45 55 65 75 85+

Vertebrae

Hip

Colles'


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Behavioral/Lifestyle Measures

to Prevent Osteoporosis

Adequate intake of dietary calcium, vitamin D,

and protein throughout life

Regular physical activity; load-bearing exercise

Minimal alcohol intake Stop smoking

Take measures to prevent falls

Use of hip protectors by patients prone to falling

Ebeling PR. N Engl J Med. 2008;358:1474-1482; National Osteoporosis Foundation. Clinicians Guide to Prevention and

Treatment of Osteoporosis. Available at: www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 22, 2008.


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Which of the following is true with regard

to vitamin D and bone health?

1 2 3 4

88%

3%2%7%


1. Oral vitamin D reduces the riskof hip fractures by 26%

2. Oral vitamin D has no benefitin preventing falls in osteoporoticpatients

3. Only vitamin D absorbed throughthe skin is effective in preventingosteoporosis

4. Vitamin D supplementationhas no effect on nonvertebralfractures


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Vitamin D Protects Against

Osteoporosis

Oral vitamin D supplementation 700-800 IU/d

reduces risk of

Hip fracture by 26%

Nonvertebral fracture by 23% Falls by 22% ( muscle strength, better balance)

Optimal fracture prevention achieved with

25-hydroxyvitamin D mean serum level 100 nmol/L

Best sourcesMilk, salmon, canned tuna, sardines,

eggs, liver, sunlight

Bischoff-Ferrari HA , et al. JAMA. 2005;293:2257-2264.


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National Osteoporosis Foundation Clinical

Recommendations 2008

National Osteoporosis Foundation Clinical Recommendations

February 2008 are based on the newly developed WHO 10-

year fracture risk model (FRAX) adapted to different

population groups

The FRAX algorithm Estimates the likelihood of a person breaking a bone due

to osteoporosis during the next 10 years

Provides a useful way to ensure that people at risk of

fracture receive treatment

Takes into account 9 clinical risk factors in addition to bonemineral density

Available online at http://www.shef.ac.uk/FRAX

National Osteoporosis Foundation. Clinicians Guide to Prevention and Treatment of Osteoporosis.

Available at: www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 22, 2008.
http://www.shef.ac.uk/FRAXhttp://www.nof.org/professionals/Clinicians_Guide.htmhttp://www.nof.org/professionals/Clinicians_Guide.htmhttp://www.shef.ac.uk/FRAX


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Risk Factors Used to Calculate

WHO 10-Year Fracture Risk

Femoral neck T-score

Age

Sex

Secondary osteoporosis Previous low-trauma

fracture

Low BMI

Steroid exposure

Family history of hip

fracture Current cigarette smoking

Alcohol intake >2 units/day*

*1 unit = 8 g alcohol ~ pt beer ~ 1 glass wine.

BMI = body mass index.Kanis JA, et al. Bone. 2002;30:251-258; Kanis JA, et al. Osteoporos Int. 2005;16:581-589; National Osteoporosis

Foundation. Clinicians Guide to Prevention and Treatment of Osteoporosis. Available at:

www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 22, 2008.


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10-Year Fracture Risk: Age and BMD

For a given BMD, risk increases with age

Kanis JA, et al. Osteoporos Int. 2001;12:989-995.

HipFractureR

isk

(%/10Years

)

-3

60

70

80

Age

0

5

10

15

20

50

BMD T-Score

-2.5 -2 -1.5 -1 -0.5 0 0.5 1


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Clinical Evaluation of

Risk Factors for Osteoporosis

Medical history

Risk factors

Signs and symptoms

Physical examination

Height assessment (with stadiometer)

BMD testing

Laboratory tests


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Central Dual Energy X-Ray Absorptiometry

(DEXA): Test of Choice for Diagnosing Osteoporosis

Benefits

Highly accurate and precise

Profiles all skeletal areas

Requires little time

Emits low dose of radiation

Limitations

AP spine measurement affected by vascularcalcifications and spinal osteoarthritis

Trabecular and cortical bone measured together

AP = anteroposterior.


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Who Should Have a Bone Density

Test?

YesAll men with a fragility fracture

YesMen aged 70 yearsYesYesAnyone considering therapy for osteoporosis

YesYesAnyone receiving treatment for osteoporosis

YesYesYesDiseases/conditions/drugs causing osteoporosis

YesYesYesAll women with a fragility fracture

YesYesYesAll women 65 with risk factorYesYesYesYesWomen 60 64 with risk factor

YesYesYesYesWomen 65 years of age

ISCDAACENOFUSPSTFPatient Category

USPTF. Ann Intern Med 2002 137:526-8; Leib, E. S., et al. J Clin Densitom 1998 7:1-6; Endocr Pract 7:293-312


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T-Score

Number of SDs above or below sex-matched mean reference

value of young adults

T-score = (BMD patient BMD young normal reference)

SD young normal reference

Comparison to peak bone mass Peak adult bone mass follows a normal distribution

(bell curve). Low bone mass on initial DEXA does not

necessarily mean bone loss. Person may be at low end

of bell curve

Used for adult diagnosis Each SD decrease = doubling of fracture risk

NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Treatment. JAMA.

2000;285:785-795.


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Which of the following applies to the

WHO/NOF criteria for diagnosis of osteoporosis?

1 2 3 4

6%

77%

2%

15%


1. T-score > -1.02. T-score between

-1 and -2.3

3. T-score is not a

WHO/NOF criterionfor diagnosingosteoporosis

4. T-score -2.5


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*Measured in T-scores. T-score indicates the number of standard deviations below or above the

average peak bone mass in young adults.

WHO/NOF Criteria for Diagnosis

of Bone Status

Ebeling PR. N Engl J Med. 2008;358:1474-1482; National Osteoporosis Foundation. Clinicians Guide to Prevention

and Treatment of Osteoporosis. Available at: www.nof.org/professionals/Clinicians_Guide.htm.


Diagnostic Criteria* Classification

T-score > -1.0

T-score -1.0 to -2.5

T-score -2.5 T-score -2.5 +

fracture(s)

Normal

Osteopenia

Osteoporosis Severe or established

osteoporosis

Fracture Rates Correlate With T Scores:


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FractureRate/100

Person-Years

Siris ES, et al. JAMA. 2001;286:2815-2822.

Fracture Rates Correlate With T-Scores:National Osteoporosis Risk Assessment(NORA) Study

Data From More Than 163,000 Women


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National Osteoporosis Foundation:

Treatment Recommendations

Postmenopausal women and men aged >50 years

with either of the following

Low bone mass (T-score -1 to -2.5, osteopenia)

at femoral neck, total hip, or spine and 10-yearhip fracture risk >3%

10-year all major osteoporosis-related

fracture risk >20% based on US-adapted

WHO FRAX model

National Osteoporosis Foundation. Clinicians Guide to Prevention and Treatment of Osteoporosis. Available at:



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ACR Recommendations:

Bisphosphonate Use in GIO

Prevention of bone loss in patients initiating

long-term (3 months) glucocorticoid therapy

Patients with low BMD (T-score 1) receiving

long-term glucocorticoid therapy Patients receiving long-term glucocorticoid therapy

who cannot tolerate HRT or had fractures during HRT

ACR = American College of Rheumatology; GIO = glucocorticoid-induced osteoporosis;

HRT = hormone replacement therapy.American College of Rheumatology Ad Hoc Committee on Glucocorticoid-Induced Osteoporosis.

Arthritis Rheum. 2001;44:1496-1503.


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Randomized, controlled trials with the bisphosphonate

alendronate demonstrated reductions in risk of hip fracture

at month 18 by:

1 2 3 4

1%

41%

46%

12%


1. 60%

Effects of Alendronate on Cumulative Incidence


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Effects of Alendronate on Cumulative Incidenceof Symptomatic Vertebral and Hip Fractures(FIT 1 and 2 Trials)

ALN = alendronate; FIT = Fracture Intervention Trial; PBO = placebo.Black DM, et al. J Clin Endocrinol Metab. 2000;85:4118-4124.

*P


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Risedronate Reduces Risk of Vertebral

Fracture in High-Risk Subjects in 1 Year

PlaceboRisedronate 5 mg

0

2

4

6

8

10

12

14

Overall 2 PrevalentFractures

68%(51%, 80%)

P


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Zoledronic Acid

HORIZON study

3-year study to decrease fracture risk in

postmenopausal women with osteoporosis

Pivotal Fracture Trial (PFT)3-year study to decrease fracture risk in

postmenopausal women with osteoporosis

Efficacy 70% vertebral fractures, 40% hip

fractures, 25% nonvertebral fractures

Black DM, et al. N Engl J Med. 2007;356:1809-1822.


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*P= .0024, relative risk reduction vs placebo (95% CI)

CI = confidence interval.Adapted from Black DM, et al. N Engl J Med. 2007;356:1809-1822.

Zoledronic Acid Reduced Cumulative

3-Year Risk of Hip Fractures (Strata I + II)

1

2

3

0

Placebo (n = 3861)

Zoledronic acid (n = 3875)

Time to First Hip Fracture (months)

0 3 6 9 12 15 18 21 24 27 30 33 36

41%*

CumulativeIn

cidence(%)


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Womens Health Initiative:

Effects of HRT in Women Aged 50-79

6700 Women With 5.2 Years of Follow-up

Di

fference(%)vs

Placebo

Advantages

Disadvantages

Manson JE, at al. N Engl J Med. 2003;349:523-534.

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Cardiovascular

diseases

S

troke

Thromb.v

enous

Breastc

ancer

Intestinalcancer

Vertebralfracture

Hipfract

ure

MORE I i BMD Wi h


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Mean%Change

FromBaseline

MORE: Increase in BMD With

Long-term Raloxifene Treatment

Ettinger B, et al. JAMA. 1999;282:637-645.

3

2

1

0

-1

-2

BMD Femoral Neck

0 12 36

Months24

3

2

1

0

-1

-2

BMD Lumbar Spine

0 12 36

Months24

Placebo (n = 1512) Raloxifene 60 mg (n = 1490)

39

MORE = Multiple Outcomes of Raloxifene Evaluation.

P


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MORE: Reduction in New Vertebral Fractures

Among Women Who Completed the Study

N = 6828

RR = relative risk.Ettinger B, et al. JAMA. 1999;282:637-645.

Placebo

Raloxifene hydrochloride 60 mg/d

Raloxifene hydrochloride 120 mg/d

RR 0.5 (95% CI, 0.4-0.6)25

20

15

10

5

0%

ofPatientsWithIncident

VertebralFracture

RR 0.5 (95% CI, 0.6-0.9)

40

C l it i N l S


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Calcitonin Nasal Spray:

PROOF Study (Analysis at 5 Years)

Reduction in % of New VertebralFractures vs Placebo

N = 511

100 IU18%

(NS)200 IU33%

(P = .03)

400 IU

23%(NS)

100

0

90

80

70

60

50

40

30

20

10

No. of Hip Fractures PerGroup

NS = nonsignificant

2(NS)

4(NS)

7(NS)8

0

5

10

15

20

25

Placebo 100 IU 200 IU 400 IU

IU = international units; PROOF = Prevent Recurrence of Osteoporotic Fractures.Chesnut CH III, et al.Am J Med. 2000;109:267-276.

41

Eff t f P th id H BMD


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Effect of Parathyroid Hormone on BMD

Over 18 Months

1637 Postmenopausal Women With Prior Vertebral Fracture

PTH = parathyroid hormone.Neer RM, et al. N Engl J Med. 2001;344:1434-1441.

ChangeFromBa

seline

inBMD(%)

-2

0

2

4

6

8

10

14

12

Placebo PTH 20 g

Lumbar spine

Femoral neck

42

S FDA A d


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Summary: FDA-Approved

Osteoporosis Therapies

PMO PMO GIO GIO Men

Generic

Name

Brand

Name Prevention Treatment Prevention Treatment

Weekly

Dosing

Estrogens Various X

Alendronate Fosamax X X X X X

Risedronate Actonel X X X X X X

Ibandronate Boniva X X

Zoledronic

acid

Zometa X

Raloxifene Evista X X

Calcitonin Miacalcin X

Teriparatide Forteo X X

PMO = postmenopausal.National Osteoporosis Foundation. Clinicians Guide to Prevention and Treatment of Osteoporosis. Available at:


43


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What percent of patients will stop their

medications within 6-12 months of initiation?

1 2 3 4

1%

38%

58%

3%


1.


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Adherence and Persistence

20%-30% of patients taking oral osteoporosis

medications suspend their medications within

6-12 months of initiation due to

Side effectsLack of knowledge

Reluctance to take regular medications

Papaioannou A. Drugs Aging. 2007;24:37-55.


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FLEX Study: Persistence

FLEX

Compared effects of discontinuing alendronate

treatment after 5 years vs continuing treatment

for 10 yearsWomen who discontinued treatment after 5 years

experienced a moderate decline in BMD,

increase in biochemical markers, no higher

fracture risk except clinical vertebral fractures

FLEX = Fracture Intervention Trial Long-Term Extension.Black DM, et al. JAMA. 2006;296:2927-2938.


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Osteonecrosis of Jaw

Osteonecrosis of jaw

Potential complication of bisphosphonate

Rare

60% occur after dental extractionMost cases occur in cancer patients

Most cases associated with high-dose IV

bisphosphonate treatment in metastatic

cancer patients


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Case Study


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Postmenopausal Asian Woman

With Possible Osteoporosis

At annual physical examination for

57-year-old Asian woman

Height: 5 ft 2 in; weight: 101 lb; BMI: 18.5 kg/m2

Postmenopausal for 5 yearsNo HRT

Medications: mesalamine for ulcerative colitis

No known drug allergies

Family history: mother had a hip fracture

at age 76 years


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Postmenopausal Asian Woman

With Possible Osteoporosis

Medical history: GERD, used PPIs daily

for 5 years; ulcerative colitis, uses mesalamine;

has used systemic steroids orally 3 or 4 times

for limited periods of time

Diet: balanced, except does not include dairy

(lactose intolerant)

Exercise: walks 20 minutes a day

Smokes pack a day

GERD = gastroesophageal reflux disease.


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Should this patient have a DEXA scan?

Use your keypad to vote now! 1 2 3

0%

98%

2%

1. No, she is


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Risk Factors for Osteoporotic Fracture

Aged >70 years

Menopause aged


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DEXA scan indicates T score 1.9

lumbar spine; T-score -.9 femoral neck.

Does this patient have osteoporosis?

1 2 3

34%

7%

59%


1.Yes

2.No

3.Not enoughinformation

WHO/NOF Criteria for Classification


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WHO/NOF Criteria for Classification

of Bone Status

National Osteoporosis Foundation. Clinicians Guide to Prevention and Treatment of Osteoporosis.

Available at: www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 22, 2008.

*T-score = number of standard deviations below or above the average peak bone mass inyoung adults.

Diagnostic criteria*

T-score > -1

T-score between -1 and -2.5

T-score -2.5

T-score -2.5 + fragility

fracture(s)

Classification

Normal

Osteopenia

Osteoporosis

Severe or established

osteoporosis

Wh t t t t h ld b


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What treatment should be

recommended for this patient?

1 2 3

0%

93%

7%


1. Ca+ 1200-1500 mg/d

2. Ca+ 1200-1500 mg/d +

800 IU vitamin D

3. All of the above plus

smoking cessationand consider adding

a bisphosphonate

National Institutes of Health


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National Institutes of Health

Recommendations for Calcium Intake

NIH. Dietary Supplement Fact Sheet: Calcium. 2005. Available at:http://ods.od.nih.gov/factsheets/calcium.asp.


Age(years)

Calcium Intake(mg/d)

1-3

4-89-18

19-50

>51

>65

500

8001300

1000

1200

1500

56

Nonpharmacologic Approaches


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Nonpharmacologic Approaches

to Postmenopausal Osteoporosis

Adequate intake of dietary calcium, vitamin D,

and protein

Regular physical activity

Minimize alcohol intake Stop smoking

Minimize risk of falls

Recommend hip protectors for those prone to falls

Antiresorptive Therapy With


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Alendronate in Osteoporosis

Clinical trials indicate increased bone mass over 3 to 4 years

Reduces incidence of fractures in spine, hip, and wrist

by 47%-51%

Prevention or treatment PMO

Approved treatment menApproved treatment GIO

Fracture efficacy (FIT and FOSIT trials)

Year 1 nonvertebral fracture reduction: 47%

Year 3 vertebral fracture reduction: 47% Year 3 hip fracture reduction: 51%

FOSIT = Fossa Intervention Trial.

Black DM, et al. J Clin Endocrinol Metab. 2000;85:4118-4124; Pols HA, et al. Osteoporos Int. 1999;9:461-468.



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Risedronate in Osteoporosis

Increased bone mass spine, hip; reduced risk fractures

40%-65% in a 3- to 5-year period

Prevention or treatment of PMO

Approved prevention or treatment of GIO

Approved in treatment for men Dose: 5 mg/d or 35 mg every week or 75 mg 2 consecutive

days a month

Fracture efficacy (VERT and HIP trials)

Year 3 vertebral fracture reduction: 41%-49%

Year 1 vertebral fracture reduction: 65% Year 3 hip fracture reduction: 40%-60%

HIP = Hip Intervention Program; VERT = Vertebral Efficacy With Risedronate Therapy.

Deal CL. Cleve Clin J Med. 2002;69:964,968-970,973-976; Harris ST, et al. JAMA. 1999;282:1344-1352;

Reginster J, et al. Osteoporos Int. 2000;11:83-91.



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Ibandronate in Osteoporosis

BONE study

Efficacy: ~50% reduction in vertebral fractures

by year 3

Bisphosphonate for PMO Dosing

150 mg once a month, MOBILE study

3 mg IV once every 3 months, DIVA study

BONE = Bone, Osteogenesis, Nonsteroidal Anti-Inflammatory Drug ; DIVA = Dosing IntraVenous

Administration; MOBILE = Monthly Oral iBandronate In LadiEs.Miller PJ. J Bone Miner Res. 2005;1315.


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Q & A


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PCE Takeaways


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PCE Takeaways

Osteoporosis is a preventable diseasenot a

condition of aging

Technology for accurate bone density measurement

is available

Women and men at risk can be identified

Safe and effective pharmacologic treatments

are available

Patient education is critical to encouragepersistence with medication in the management

of osteoporosis

How confident are you now in


64/65

64

y

discussing the various modifiable risk

factors for osteoporosis with your patients?

1 2 3

89%

1%

10%


1. Very confident2. Somewhat confident

3. Not at all confident


65/65

Radisson Hotel at Opryland

Nashville, Tennessee

May 31, 2008

SymposiaSeries 22008

Documents

6--PCE Nashville Osteoporosis Knudtson