Who cares about fractures! is more important. October 3, 2014 CSIM Workshop Brian Wirzba, MD, FRCPC, FACP Clinical Professor Grey Nuns Hospital

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$Isn t Osteoporosis just a T Score less than 2.5?? Who cares about fractures! is more important.$

1 Isn t Osteoporosis just a T Score less than 2.5?? Who cares about fractures! is more important. Why do I need to know this? October 3, 2014 CSIM Workshop Brian Wirzba, MD, FRCPC, FACP Clinical Professor Grey Nuns Hospital

2 Declaration of Conflict of Interest I, Brian Wirzba, declare that in the last 3 years: o I have received manufacturer funding from the following companies*: o None o I have done consulting work for the following companies*: o Amgen & Eli Lilly o I have done speaking engagements for the following companies*: o Amgen o I or my family hold individual shares in the following companies*: o None * Pharmaceutical or medical/dental equipment

3 What if o You recognized a new condition that: o Shortened life spans and detrimentally affected quality of life o Became more common as people got older o You had a treatment that reduced the rate of the new condition by 50% along with its associated morbidity & mortality o Would you think it was important?? o Would you treat it???

You had a treatment that reduced the rate of the new condition by 50% along with

4 What if o You recognized a new condition that: o Shortened life spans and detrimentally affected quality of life o Became more common as people got older o You had a treatment that reduced the rate of the new condition by 50% along with its associated morbidity & mortality o Would you think it was important?? o Would you treat it???

5 What About Low Bone Density?? You have a patient with an LDL of 2.6. Will you start them on a statin? You have a patient with a T-score of Will you start them on a bisphosphonate? So why do we talk about T-scores so much?

6 WHO Definition Normal Distribution of BMD for y.o. women Percent of Population Osteoporosis T score WHO, Guidelines for Preclinical Evaluation and Clinical Trials in Osteoporosis, 1998

7 T scores Statistical diagnosis Normal Distribution of BMD for y.o. women Percent of Population >99 Osteoporosis Osteopenia T score WHO, Guidelines for Preclinical Evaluation and Clinical Trials in Osteoporosis, 1998

8 T scores Statistical diagnosis Normal Distribution of BMD for 30 40, 40 50, 50 60, 60 70, y.o. women Percent of Population >99 Osteoporosis Osteopenia T score WHO, Guidelines for Preclinical Evaluation and Clinical Trials in Osteoporosis, 1998

9 Why isn t BMD enough?

10 NIH Consensus Definition Osteoporosis is a skeletal disorder characterized by compromised bone strength predisposing a person to an increased risk of fracture. Bone strength primarily reflects the integration of bone density and bone quality. NIH Consensus Development Panel, JAMA 2001;285:785

11 It Can Get Complicated! F. Cosman et al, Osteoporos Int 2014;25:2359

12 The goal is NOT to cure low bone density but rather to PREVENT FRACTURES

13 Why care about fractures when there is so much more IM s need to deal with? Quit worrying about your health. It ll go away. Sir William Osler

14 US Women Incidence Rates (2005) 2,000,000 Annual Incidence 1,500,000 1,000, , ,456, ,000 other sites 327,000 wrist 103,000 pelvic 223,000 hip 389,000 vertebral Osteoporotic fractures 345,000 Heart attack 373,000 Stroke 269,730 Breast cancer Burge R et al, J Bone Miner Res 2007;22:465 Jemal A et al, CA Cancer J Clin 2005;55:10 Rosamond W et al, Circulation 2007;115:e69

15 2007/2008 Prevalence Rates O Donnell & Canadian Chronic Disease Surveillance System, Arch Osteoporos 2013;8:143

16 Fractures and Mortality Morin et al., Osteoporos Int 2011;22:2439

17 Fracture Burden and Mortality Kado et al., Arch Intern Med 1999;159:1215

Loss of Independence 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 11.3 18 21.6 14.3 15.5 10.

19 Loss of Independence 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% At Discharge At 6 month At 12 month Deceased Transfer Rehab Hosp LTC Community Osteoporos Int 2001;12:271

Fractures Cost Money 2007/2008 Canada 29874 Acute Care Admissions for Stroke 49220 Acute Care Admissions for MI

2007/2008 Canada Total & Acute Cost doubled (in 2010 $ s) Population over 50 doubled LTC Care and Drug costs

20 Fractures Cost Money 2007/2008 Canada Acute Care Admissions for Stroke Acute Care Admissions for MI 1993 vs. 2007/2008 Canada Total & Acute Cost doubled (in 2010 $ s) Population over 50 doubled LTC Care and Drug costs also increased /2008 Canada Acute Care Admissions Hospitalized Days $2.3B Basic Care Costs $3.9B Basic Care plus LTC Costs 3.1M Missed work days in y.o. Tarride et al., Osteoporos Int 2012;23:2591

22 Great Wave off Kanagawa by Katsushika Hokusai ( 葛飾北斎 )

23 Insert any number of slides from DB/PC/RC trials that show current first line drugs increase Bone Density

24 Insert any number of slides from DB/PC/RC trials that show current first line drugs reduce fractures 40 60%

25 When was the last time you saw a patient with hip fracture? What intervention would reduce their risk of dying by ¼ over 3 years?

HORIZON RFT Results MORTALITY Cumulative Incidence (%) 18 16 14 12 10 8 6 4 2 0 Placebo (n = 1062) ZOL 5 mg (n = 1065) 28%* 13.3 9.6% ARR 3.

26 HORIZON RFT Results MORTALITY Cumulative Incidence (%) Placebo (n = 1062) ZOL 5 mg (n = 1065) 28%* % ARR 3.7% NNT No. at Risk Month ZOL 5 mg Placebo Brian Wirzba, MD. FRCP(C) Lyles, et al., NEJM 2007;347:1799

If you treated 100 patients with a therapy that reduces risk 40% Fracture Risk Fractures that Occur Prevented Fractures What about other things we do?

5 NNT 125 for all HTN to prevent death Treating patients with KNOWN CAD with ASA: NNT 50 to prevent more CVD NNT 77 to prevent non fatal MI 30 18 12 8 40 NNT 333

27 If you treated 100 patients with a therapy that reduces risk 40% Fracture Risk Fractures that Occur Prevented Fractures What about other things we do? NNT 10Treating HTN with meds: NNH 12 if mild hypertension with no significant benefit 20 NNT 67 for all HTN 12to prevent stroke NNT 125 for all HTN to prevent death Treating patients with KNOWN CAD with ASA: NNT 50 to prevent more CVD NNT 77 to prevent non fatal MI NNT 333 to prevent 24 death 16 6 Treating patients with KNOWN CAD with statins: 50 NNT 39 to prevent 30nonfatal MI 20 5 NNT 83 to prevent death NNH 10 for myalgias and?50 for DM development

28 Treatment Reduces Mortality (in trials) Grey & Bolland, Osteoporos Int 2013;24:1

29 Treatment Reduces Mortality (in Edmonton) Beaupre et al., Osteoporos Int 2011;22:983

30 Treatment Reduces Mortality Center et al., J Clin Endocrinol Metab 2011;96:1006

31 Treating High Risk is Cost Effective

32 In ALL trials the greater the risk, the greater the benefit. Yield in low risk populations is LOW.

33 Next step with 60 y.o. female with vertebral wedge fracture 70 y.o. female with low trauma femoral neck fracture Chami et al., BMC Family Practice 2006;7:7

35 Canadian OP Care Gap 100% 80% 60% 80% 40% 20% 15% 0% Fragility Fracture Heart Attack Bessette et al., Osteoporos Int 2008;19:79 Austin PC, et al. CMAJ. 2008;179:895

36 Why the gap?? Austin PC, et al. CMAJ. 2008;179:895

37 Trends with CV Meds Post MI CMAJ 2008;179:901 9

38 Your patient has an LDL of 2.6 Would you start lipid lowering therapy??

40 Risk of Major Osteoporotic Fracture 40 T 1.0 SD T 2.0 SD T 2.5 SD T 3.0 SD T 4.0 SD No BMD / ( )Fx No BMD / (+)Fx 35 10yr Fracture Rate Age Female 70kg, 5 8

44 Using FRAX Risk Group Overall Risk Treatment Low <10% Lifestyle Moderate 10 20% High >20% Lifestyle +/ Medication Lifestyle plus Medication

45 How accurate is FRAX Canada? Fraser et al, Osteoporos Int 2011;22:829

46 What about treatment side effects?

47 Osteonecrosis of the Jaw R Mandible ONJ following tooth extraction in patient on ZOL for metastatic Breast Ca Ann Intern Med 2006;144:753

48 Osteonecrosis of the Jaw 1 10 in py in Osteoporosis patients Palatal torus ONJ in patient on ALN for Osteoporosis Ann Intern Med 2006;144:753

49 Atypical Femoral Fractures in py in Osteoporosis patients Between lesser trochanter and supracondylar flare Major feature (need 4 of 5) Minimal (or no) trauma Fracture line originates at lateral cortex and is initially transverse Noncomminuted or only minimally so Medial spike if complete Localized periosteal or endosteal thickening Minor feature (extra s) Increased cortical thickness of the femur Prodromal Sx of pain (unilateral/bilateral) Bilateral fractures (complete/incomplete) Delayed fracture healing Shane, et al., J Bone Min Res 2014;29:1

50 Incidence of Hip Fractures (US) X Men O Women BPs decrease risk by 1/2 Absolute Risk remains HIGH BPs increase risk by Absolute Risk remains v. low Nieves et al, Osteoporos Int 2010;21:399

51 Atypical Femoral Fractures

52 Let s get a reality check

53 1000 Average Jane

54 1000 Average Jane 30% Risk

55 1000 Average Jane 50% RR

$1/1000 Over 3 years of treatment: 150 fractures still occur 150 fractures are$

56 1000 Average Jane /1000 Over 3 years of treatment: 150 fractures still occur 150 fractures are prevented 15 typical hip # s prevented Atypical Fractures

57 What is the real risk!!

58 1000 Average Jane 30% Risk

59 1000 Average Jane 15% Rx Rate

$5 fractures are prevented (vs.$ $150) 278 fractures still occur (vs.$ 25 typical hip # s prevented (vs.

60 1000 Average Jane 50% RR Over 3 years of treatment: 150 patients get treated 850 patients don t get treated 22.5 fractures are prevented (vs. 150) 278 fractures still occur (vs. 150) 2.25 typical hip # s prevented (vs. 15) 27.8 typical hip # s still occur (vs. 15) Atypical Fractures (vs )

61 Health is merely the slowest possible rate at which one can die Unknown

Fracture=Bone Attack:

Fracture=Bone Attack: Linking Hip Fractures to Osteoporosis Care Angela M. Cheung, MD, PhD, FRCPC Professor of Medicine, University of Toronto Potential Conflicts of Interests Industry Grants (to UHN)