2008

Symposia Series 2

Radisson Hotel at Opryland Nashville, Tennessee May 31, 2008

1

Osteoporosis Update: Prevention, Diagnosis, and Treatment

Mary D. Knudtson, DNSc, NP Clinical Professor Department of Family Medicine University of California, Irvine Irvine, California

Faculty Disclosure
Dr Knudtson: consultant/speakers bureau:

Procter & Gamble

How confident are you addressing modifiable risk factors for osteoporosis with your patients?

1. Very confident 2. Somewhat confident 3. Not at all confident

Use your keypad to vote now!

62%

32%

6%

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 pharmacologic management

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] Bone density = grams of mineral/area, volume Bone 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

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 osteoporosisrelated fracture Asian Americans with osteoporosis have same fracture risk as white persons
*Estimates based on 2000 census data. 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.

Which of the following best characterizes the burden of osteoporosis?

1. Osteoporotic fractures are more common than MI, stroke, and breast cancer combined 2. Only MIs are more prevalent than osteoporotic fractures 3. Incidence of osteoporotic fractures is equal to that of MIs 4. None of the above
72%

20% 6% 2%
3 4

Use your keypad to vote now!

MI = myocardial infarction. 8
1 2

Osteoporotic Fractures Are More Common Than MI, Stroke, and Breast Cancer Combined
2,000,000

Annual incidence of Common Diseases

1,500,000*
1,500,000 250,000 hip 250,000 forearm 250,000 other sites 500,000 750,000 vertebral 0

1,000,000

513,000 228,000** 184,300

Osteoporotic Fractures

MI

Stroke

Breast Cancer

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

Which of the following is a common cause of secondary osteoporosis?

1. Proton pump inhibitors (PPIs) 2. Treatment for ulcerative colitis 3. Glucocorticoids 4. TNF- receptor blockers and IL-1 receptor antagonists for the treatment of rheumatoid arthritis
10%
Use your keypad to vote now!
1

81%

5%
2 3

4%
4

10

Factors Contributing to Secondary Osteoporosis

Lifestyle Low calcium intake, high caffeine intake, excessive alcohol consumption, smoking, immobilization Hyperthyroid, hyperparathyroid, adrenal insufficiency, Cushings syndrome, diabetes Androgen insensitivity, anorexia/bulimia, athletic amenorrhea, hyperprolactinemia, panhypopituitarism Gastrectomy, GI bypass, celiac disease, malabsorption, inflammatory bowel disease Hemophilia, rheumatic and autoimmune conditions, sickle cell, thalassemia, lymphoma, myeloma Alcoholism, amyloidosis, CHF, epilepsy, ESRD, MS, prior fracture as adult, epilepsy, depression Glucocorticoids, anticoagulants, anticonvulsants, aromatase inhibitors, cyclosporine, lithium, cancer chemotherapy, depomedroxyprogesterone

Endocrine disorders
Hypogonadal states GI disorders Hematologic diseases Miscellaneous conditions Medications

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.

11

Glucocorticoid Use and Fracture Risk

6

Relative Risk of Fracture Compared With Control

4
3 2

All nonvertebral Forearm Hip Vertebral

2.59 1.55 1.17 1.1 0.99 1.77 1.36 1.04 1.64 2.27

5.18

1.19

1
0 n=

2192 531 236 191

2486 526 494 440

1665 273 328 400

Low Dose (<2.5 mg/d)

Medium Dose (2.5-7.5 mg/d)

High Dose (>7.5 mg/d)

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

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Pathophysiology of Osteoporosis
Bone Remodeling
Resting Bone
Activation Resorption

Osteoclasts

Bone
Reversal Formation

Osteoblasts

Bone Osteoid
13

Bone Mineralization

Pathophysiology of Osteoporosis

Early menopausal bone loss

Calcium/ vitamin D deficiency Other factors

Inadequate peak bone mass

Decrease in bone mass/bone quality

Low bone mass/ impaired bone quality

Fractures

Trauma

14

Changes in Trabecular Architecture

20 years Decrease in trabecular thickness, more

50 years

pronounced for non load-bearing horizontal trabeculae Decrease in connections between horizontal trabeculae Decrease in trabecular strength and increased susceptibility to fracture

80 years

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

15

Location of Cortical and Trabecular Bone

Trabecular Bone 20% of skeletal mass 80% of bone turnover Cortical Bone 80% of skeletal mass 20% of bone turnover
Thoracic and Lumbar Spine 75% trabecular 25% cortical

Distal Radius

25% trabecular 75% cortical

Femoral Neck

25% trabecular 75% cortical

Hip: Intertrochanteric Region

50% trabecular 50% cortical

Favus MJ, ed. Primer on the Metabolic Bone Disease and Disorders of the Mineral Metabolism. 4th ed. Philadelphia, Pa: Lippincott Williams and Wilkins; 1999:30-32.

16

Fracture Patterns By Age

4000

Vertebrae

Annual Fracture Incidence /100,000

3000

Hip

2000

1000

Colles'

0 35
Riggs B. N Engl J Med 1986;314:1676.

45

Age (years)

55

65

75

85+

17

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.

18

Which of the following is true with regard to vitamin D and bone health?
1. Oral vitamin D reduces the risk of hip fractures by 26% 2. Oral vitamin D has no benefit in preventing falls in osteoporotic patients 3. Only vitamin D absorbed through the skin is effective in preventing osteoporosis 4. Vitamin D supplementation has no effect on nonvertebral fractures

88%

7%
Use your keypad to vote now!
1 2

2%
3

3%
4

19

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 sources Milk, salmon, canned tuna, sardines, eggs, liver, sunlight
Bischoff-Ferrari HA , et al. JAMA. 2005;293:2257-2264.

20

National Osteoporosis Foundation Clinical Recommendations 2008

National Osteoporosis Foundation Clinical Recommendations

February 2008 are based on the newly developed WHO 10year 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 bone mineral 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.

21

Risk Factors Used to Calculate WHO 10-Year Fracture Risk

Femoral neck T-score Age Sex Low BMI Steroid exposure Family history of hip

Secondary osteoporosis
Previous low-trauma

fracture

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.

22

10-Year Fracture Risk: Age and BMD

For a given BMD, risk increases with age
20 Hip Fracture Risk 15 10
60
Age 80

(% /10 Years)

70

5
50

0 -3
-2.5 -2 -1.5 -1 BMD T-Score -0.5 0 0.5 1

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

23

Clinical Evaluation of Risk Factors for Osteoporosis

Medical history

factors Signs and symptoms Physical examination Height assessment (with stadiometer) BMD testing Laboratory tests

Risk

24

Central Dual Energy X-Ray Absorptiometry (DEXA): Test of Choice for Diagnosing Osteoporosis
Benefits

accurate and precise Profiles all skeletal areas Requires little time Emits low dose of radiation Limitations AP spine measurement affected by vascular calcifications and spinal osteoarthritis Trabecular and cortical bone measured together
AP = anteroposterior.
25

Highly

Who Should Have a Bone Density Test?

Patient Category Women 65 years of age US PSTF Yes NOF Yes AACE Yes ISCD Yes

Women 60 64 with risk factor

All women 65 with risk factor All women with a fragility fracture

Yes

Yes
Yes Yes Yes

Yes
Yes Yes Yes Yes

Yes
Yes Yes Yes Yes Yes

Diseases/conditions/drugs causing osteoporosis Anyone receiving treatment for osteoporosis Anyone considering therapy for osteoporosis

Yes

Men aged 70 years

All men with a fragility fracture

Yes
Yes

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

26

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.

27

Which of the following applies to the WHO/NOF criteria for diagnosis of osteoporosis?

1. T-score > -1.0 2. T-score between -1 and -2.3 3. T-score is not a WHO/NOF criterion for diagnosing osteoporosis 4. T-score -2.5
15% 6%
Use your keypad to vote now!
1 2 3

77%

2%
4

28

WHO/NOF Criteria for Diagnosis of Bone Status

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

*Measured in T-scores. T-score indicates the number of standard deviations below or above the average peak bone mass in young adults.
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.

29

Fracture Rates Correlate With T-Scores: National Osteoporosis Risk Assessment (NORA) Study
Data From More Than 163,000 Women

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

30

Fracture Rate/100 Person-Years

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-year hip 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: www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 22, 2008.

31

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.

32

Randomized, controlled trials with the bisphosphonate alendronate demonstrated reductions in risk of hip fracture at month 18 by:

1. 2. 3. 4.

<10% 15%-25% 30%-40% >60%

46% 41%

12% 1%
Use your keypad to vote now!
1 2 3 4

33

Effects of Alendronate on Cumulative Incidence of Symptomatic Vertebral and Hip Fractures (FIT 1 and 2 Trials)
5

Vertebral
Cumulative Incidence

Hip -63%
PBO P <.014 ALN

Cumulative Incidence

4 3 2 1 0 0 6

-59%
PBO P <.001 ALN

*
12

*
18

* *
24 30

* *
0 0 6 12 18 24

* *
30 36

36

Months

Months

*P <.05
ALN = alendronate; FIT = Fracture Intervention Trial; PBO = placebo.
Black DM, et al. J Clin Endocrinol Metab. 2000;85:4118-4124. 34

34

Risedronate Reduces Risk of Vertebral Fracture in High-Risk Subjects in 1 Year

14 68% 62% 62%
(44%, 75%) P <.001 (36%, 77%) P <.001 (51%, 80%) P <.001

60%
(33%, 77%) P <.001

Placebo Risedronate 5 mg

Percent of Subjects With New Vertebral Fractures

12 10 8 6

48%
(7%, 71%) P = .029

4
2 0 Overall Aged 70 Years 2 Prevalent Fractures Low FN BMD Low LS BMD

FN = femoral neck; LS = lumbar spine.

Watts NB, et al. J Clin Endocrinol Metab. 2003;88:542-549.

35

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.

36

Zoledronic Acid Reduced Cumulative 3-Year Risk of Hip Fractures (Strata I + II)
3

Cumulative Incidence (%)

Placebo (n = 3861) Zoledronic acid (n = 3875)

41%*

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

Time to First Hip Fracture (months)

*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.

37

Womens Health Initiative: Effects of HRT in Women Aged 50-79

6700 Women With 5.2 Years of Follow-up
Difference (%) vs Placebo
Intestinal cancer Vertebral fracture

Disadvantages

Thromb. venous

Cardiovascular diseases

Stroke

Breast cancer

Advantages

Manson JE, at al. N Engl J Med. 2003;349:523-534. 38

38

Hip fracture

MORE: Increase in BMD With Long-term Raloxifene Treatment

BMD Lumbar Spine
Placebo (n = 1512)
3 3 2

BMD Femoral Neck

Raloxifene 60 mg (n = 1490)

Mean % Change From Baseline

1
0 -1

1
0 -1

-2
0 12 24 36

-2
0 12 24 36

Months
P <.001 for all comparisons.
MORE = Multiple Outcomes of Raloxifene Evaluation.
Ettinger B, et al. JAMA. 1999;282:637-645.

Months

39

39

MORE: Reduction in New Vertebral Fractures Among Women Who Completed the Study
% of Patients With Incident Vertebral Fracture
25 20
Placebo Raloxifene hydrochloride 60 mg/d Raloxifene hydrochloride 120 mg/d
RR 0.5 (95% CI, 0.4-0.6) RR 0.5 (95% CI, 0.6-0.9)

15 10
5 0

N = 6828
RR = relative risk.
Ettinger B, et al. JAMA. 1999;282:637-645.
40

40

Calcitonin Nasal Spray: PROOF Study (Analysis at 5 Years)

Reduction in % of New Vertebral Fractures vs Placebo
0 10 20 30 40 50 60 70 100 IU 18% (NS) 200 IU 33% (P = .03) 400 IU 23% (NS)
20

25

No. of Hip Fractures Per Group

15

10

80
90 100

2 (NS)

4 (NS)

7 (NS)

Placebo 100 IU

200 IU

400 IU

N = 511
Chesnut CH III, et al. Am J Med. 2000;109:267-276.

NS = nonsignificant

IU = international units; PROOF = Prevent Recurrence of Osteoporotic Fractures.

41

41

Effect of Parathyroid Hormone on BMD Over 18 Months

1637 Postmenopausal Women With Prior Vertebral Fracture
14
Lumbar spine Femoral neck

Change From Baseline in BMD (%)

12 10 8 6 4 2 0 -2

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

PTH 20 g

42

42

Summary: FDA-Approved Osteoporosis Therapies

PMO Generic Name Estrogens Alendronate Risedronate Ibandronate Brand Name Various Fosamax Actonel Boniva Prevention X X X X X X X X X X X X X X PMO Treatment GIO Prevention GIO Treatment
Men

Weekly Dosing

Zoledronic acid
Raloxifene Calcitonin Teriparatide

Zometa
Evista Miacalcin Forteo X

X
X X X X

PMO = postmenopausal.
National Osteoporosis Foundation. Clinicians Guide to Prevention and Treatment of Osteoporosis. Available at: www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 22, 2008. 43

43

What percent of patients will stop their medications within 6-12 months of initiation? 1. <10% 2. 10%-15% 3. 20%-30% 4. 40%-50%
58%

38%

1%
Use your keypad to vote now!
1

3%
2 3 4

44

Adherence and Persistence

20%-30% of patients taking oral osteoporosis

medications suspend their medications within 6-12 months of initiation due to Side effects Lack of knowledge Reluctance to take regular medications

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

45

FLEX Study: Persistence

FLEX
Compared

effects of discontinuing alendronate treatment after 5 years vs continuing treatment for 10 years Women 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.

46

Osteonecrosis of Jaw
Osteonecrosis of jaw Potential complication of bisphosphonate Rare

occur after dental extraction Most cases occur in cancer patients Most cases associated with high-dose IV bisphosphonate treatment in metastatic cancer patients

60%

47

Case Study

48

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 years No HRT Medications: mesalamine for ulcerative colitis No known drug allergies Family history: mother had a hip fracture at age 76 years
49

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. 50

Should this patient have a DEXA scan?

1. No, she is <65 years of age 2. Yes, she is 5 years postmenopausal 3. Yes, she has multiple risk factors for osteoporosis
0% 2%
2

98%

Use your keypad to vote now!

51

Risk Factors for Osteoporotic Fracture

Major (RR 2)

Moderate (RR 1-2)

Aged >70 years Menopause aged <45 years Hypogonadism Fragility fracture Hip fracture in parents Glucocorticoids Malabsorption High bone turnover Anorexia nervosa BMI <18 kg/m2 Immobilization Chronic renal failure Transplantation

Estrogen deficiency Calcium intake <500 mg/d Primary hyperparathyroidism Rheumatoid arthritis Ankylosing spondylitis Anticonvulsants Hyperthyroidism Diabetes mellitus Smoking Alcohol in excess

Brown JP, et al. CMAJ. 2002;167(10 suppl):S1-S34.

52

DEXA scan indicates T-score -1.9 lumbar spine; T-score -.9 femoral neck. Does this patient have osteoporosis?

1. Yes 2. No 3. Not enough information

59%

34%

7%
Use your keypad to vote now!
1 2 3

53

WHO/NOF Criteria for Classification of Bone Status

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

*T-score = number of standard deviations below or above the average peak bone mass in
young adults.
National Osteoporosis Foundation. Clinicians Guide to Prevention and Treatment of Osteoporosis. Available at: www.nof.org/professionals/Clinicians_Guide.htm. Accessed April 22, 2008.

54

What treatment should be recommended for this patient?

1. Ca+ 1200-1500 mg/d 2. Ca+ 1200-1500 mg/d + 800 IU vitamin D 3. All of the above plus smoking cessation and consider adding a bisphosphonate

93%

0%
Use your keypad to vote now!
1

7%
2 3

55

National Institutes of Health Recommendations for Calcium Intake

Age
(years)

Calcium Intake
(mg/d)

1-3 4-8 9-18 19-50 >51 >65

500 800 1300 1000 1200 1500

NIH. Dietary Supplement Fact Sheet: Calcium. 2005. Available at:http://ods.od.nih.gov/factsheets/calcium.asp. Accessed April 17, 2008. 56

56

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

57

Antiresorptive Therapy With 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 men Approved 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.

58

Antiresorptive Therapy With 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.

59

Antiresorptive Therapy With Ibandronate in Osteoporosis

BONE study

~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.

Efficacy:

60

Q&A

61

PCE Takeaways

62

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 encourage persistence with medication in the management of osteoporosis
63

How confident are you now in discussing the various modifiable risk factors for osteoporosis with your patients? 1. Very confident 2. Somewhat confident 3. Not at all confident
89%

10% 1%
Use your keypad to vote now!
1 2 3

64

2008

Symposia Series 2

Radisson Hotel at Opryland Nashville, Tennessee May 31, 2008

65