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Applying the 2010 Osteoporosis Canada Guidelines

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1 Applying the 2010 Osteoporosis Canada Guidelines
Teaching Slide Kit for Canadian Family Medicine Training Programs 1

2 Learning Objectives By the end of the session, participants will be better able to: Assess patients for risk of osteoporotic fracture and calculate their 10-year fracture risk Appreciate the consequences of osteoporotic fractures and be able to communicate this to patients Implement effective treatment and management plans to reduce risk of future fractures

3 Slide Kit Outline Background – Assessment and Management of Osteoporosis Case study – Applying the 2010 OC guidelines using Q & A format 3

4 To highlight that bone strength (similar to a bridge structure) is dependent not only on bone mass (quantity), but also the quality of the material property of the bone and how the microstructures are organized (the bone microarchitecture) 4

5 Osteoporosis “porous bone”
Skeletal disorder of comprised bone strength Low bone density (Quantity) Deterioration of bone microarchitecture (Quality) Most serious consequence is fragility fracture A fracture that occurs spontaneously or from minor trauma (such as a fall from standing height or less or at walking speed or less) Harvey N, et al. Chap 40, Primer on the Metabolic Bone Disease and Disorders of Mineral Metabolism, 8th Edition (2013) Kanis JA, et al. Osteoporos Int 2001; 12: Bessette L, et al. Osteoporos Int 2008; 19:79-86 5

6 Bone Strength Bone Mass Density Bone Architecture Bone Mineral/Matrix
Bone Turnover Reid I, Chap 41, Primer on the Metabolic Bone Disease and Disorders of Mineral Metabolism, 8th Edition (2013) 6 Courtesy of Dr. Sophie Jamal

7 Bone Mineral Density (BMD)
Assessed by DXA (Dual X-ray Absorptiometry) Correlates with fracture risk But captures only one component of fracture risk Needs to be incorporated into a fracture risk calculator (eg. CAROC or FRAX tools) WHO Classification of Osteoporosis based on bone density is a T-score ≤ -2.5 Lentle B, et al. CARJ 2011; 62: 7

8 Bone Density Reporting Criteria
Age Category Criteria* < 50 years Below expected range for age Z-score < -2.0 Within expected range for age Z-score > -2.0 > 50 years Severe (established) osteoporosis T-score < -2.5 with fragility fracture Osteoporosis T-score < -2.5 Low bone mass T-score -1.1 to -2.4 Normal T-score > -1.0 Currently, a diagnosis of osteoporosis is made in older women and men who have a BMD T-score 2.5 or more standard deviation below the normal BMD for young healthy white women,1 with BMD measurement made at the femoral neck from DXA as the reference standard.2 It is appropriate to consider a clinical diagnosis of osteoporosis in individuals who have sustained fragility fracture(s) even if BMD is not in the osteoporotic range, as the majority of fractures occur in those who have a T-score above -2.5. Prior to age 50, the WHO T-score system is not appropriate; age- and sex-matched Z-scores are preferred. For Z-scores, a value -2.0 or lower is considered below the expected range for age and a value above -2.0 considered within the expected range for age.3 Similarly, the models for fracture-risk prediction discussed below should not be applied to individuals younger than age 50. Risk assessment and treatment considerations in individuals less than age 50 with medical conditions that may have adverse skeletal consequences are complex, and often benefit from consultation with a specialist. References 1. Report of a WHO Study Group. Assessment of fracture risk and its application to screening for postmenopausal osteoporosis. World Health Organ Tech Rep Ser 1994; 843:1-129. 2. Kanis JA, McCloskey EV, Johansson H, et al. A reference standard for the description of osteoporosis. Bone 2008; 42(3): 3. Leslie WD, Adler RA, El-Hajj FG, et al. Application of the 1994 WHO Classification to Populations Other Than Postmenopausal Caucasian Women: The 2005 ISCD Official Positions. J Clin Densitom 2006; 9(1):22-30. Lentle B, et al. CARJ 2011; 62:

9 BMD alone cannot assess fracture risk
BMD vs. Osteoporotic Fracture Rates/Number Fracture rate per 1000 person-years 60 50 40 30 20 10 BMD distribution No. of Fractures 450 350 300 250 200 100 150 50 400 Fracture Rate No of Fractures 60% of women with fragility fractures have non-osteoporotic bone mineral density (T-score >-2.5) Population BMD demonstrates that a higher proportion of the population has a BMD in the mid range (-2.0 to -0.5) Fracture rate shows that there is higher rate of fracture in those with OP or a T-score <-2.5, however the absolute number of fractures shows that most fractures occur at BMD T-scores ranging from -2.5 to -0.5. Data demonstrates that BMD alone cannot be used to assess fracture risk. BMD T-scores >1.0 1.0 to 0.5 0.5 to 0.0 0.0 to –0.5 –0.5 to –1.0 –1.0 to –1.5 –1.5 to –2.0 –2.0 to –2.5 –2.5 to –3.0 –3.0 to –3.5 < –3.5 Adapted from Siris ES, et al: JAMA 2001; 286:

10 Common Sites for Fracture
Spine Hip Wrist Burge J, et al. J Bone Miner Res 2007; 22: 10

11 Incidence of Osteoporotic Fractures in Canadian Women
Osteoporosis fracture incidence is higher than the incidence of heart attack, stroke, and breast cancer in Canadian women 1. Leslie WD, et al. Osteoporos Int 2010; 21:1317‐1322; 2. Burge J, et al. J Bone Miner Res 2007;22: ; 3. Public Health Agency of Canada. 2009; 4. Canadian Cancer Society/National Cancer Institute of Canada. 2007 11

12 Consequences of Fractures
More fracture(s) Chronic pain Immobility Decreased quality of life Loss of independence Institutionalization Cost to healthcare Death Hodsman AB, et al. Arch Intern Med 2008; 168:2261‐2267 Papaioannou A, et al. Osteoporos Int. 2009; 20: Ioannidis G, et al. CMAJ 2009; 181:265‐271 12

13 Many people who have sustained a fragility fracture do NOT appreciate the link to osteoporosis
Bessette L, et al. Osteoporos Int 2008; 19:79-86 13

14 Who Needs Medication for Osteoporosis?
Men and women at HIGH fracture risk: Based on calculation of 10-year fracture risk using CAROC or FRAX tools Based on fragility fracture history regardless of BMD If had fragility fracture of the hip If had fragility fracture of the spine (2/3 are asymptomatic) If had ≥ 2 non-spine, non-hip fragility fractures If had 1 non-spine, non-hip fragility fracture AND prolonged glucocorticoid use in the previous year 14

15 Fracture Risk Assessment
Canadian CAROC Tool High risk (> 20%) > 1 non-vertebral fragility fracture Hip / vertebral fracture <10% 10-20% >20% Fragility fracture after age 40 Increases to the next risk category Prolonged corticosteroid therapy* * ≥ 3 months at prednisone-equivalent dose ≥7.5mg daily during preceding year Papaioannou A, et al. CMAJ 2010;182: * At least three months cumulative use during the preceding year at a prednisone-equivalent dose ≥ 7.5 mg daily 15

16 Example of Adjusting Basal Risk: Based on Additional Risk Factors
60-year-old woman Femoral neck T-score = -2.8 Based on age and T-score alone = moderate risk 0.0 -0.5 -1.0 -1.5 -2.0 -2.5 -3.0 -3.5 -4.0 50 55 60 65 70 75 80 85 Age (years) Femoral neck T-score LOW RISK (<10%) MODERATE RISK HIGH RISK (> 20%) History of fragility fracture or prolonged systemic glucocorticoid use would shift her to high risk The presence of either prolonged systemic glucocorticoid use or history of fragility fracture after age 40 substantially elevates fracture risk independent of the basal risk category (estimated from age, sex, and BMD) and their effect is operationalized by increasing the risk categorization to the next level: from low risk to moderate risk, or from moderate risk to high risk. When both factors are present (i.e., fragility fractures and prolonged systemic glucocorticoid use), the patient is considered to be at high fracture risk regardless of the BMD result. Reference Papaioannou A, Leslie WD, Morin S, et al Clinical Practice Guidelines for the Diagnosis and Management of Osteoporosis in Canada. CMAJ 2010 Oct 12. [Epub ahead of print]. Papaioannou A, et al. CMAJ 2010;182:

17 Fracture Risk Assessment
FRAX tool (by WHO) Computes 10-yr absolute risk for hip fracture or major osteoporotic fracture Gender, Age Bone density at femoral neck Fragility fracture Glucocorticoid use Low weight (BMI) Smoking, Excess Alcohol Parental hip fracture Rheumatoid arthritis or other secondary causes 17

18 FRAX tool: Online Calculator

19 Who Needs Medication? LOW: NO Treatment MODERATE:
Depends - other Risk factors HIGH: YES – need Rx 19

20 to Consider Treatment in the Moderate Risk Patient
Top 5 Reasons to Consider Treatment in the Moderate Risk Patient Vertebral fracture (on lateral spine X-ray) or wrist fracture in patient > 65 years or BMD T-score < -2.5 Rapid bone loss or lumbar spine T-score much lower than femoral neck T-score Falls (≥2 in the past year) Concurrent high risk disorder or medications: Glucocorticoids (long-term repeated use) Aromatase inhibitor therapy Hypogonadism/premature menopause Primary hyperparathyroidism Hyperthyroidism Rheumatoid arthritis Patient preference to be treated Consideration for vertebral fracture assessment and/or lateral spine X-ray is based on physical examinations: annual height, rib-to-pelvis distance, occiput-to-wall distance (kyphosis) Note that lateral spine X-ray must be used to identify vertebral fracture(s) as VFA is not widely available in Canada Rapid changes in BMD is not precisely defined, but would represent a significant drop in a patient’s BMD since last visit Lumbar spine T-score as lower than femoral neck is also not precisely defined: > 1 or 2 T-score standard deviations would be significant Disorders associated with osteoporosis and increased fracture risk1: Primary hyperparathyroidism Type I diabetes Osteogenesis imperfecta Untreated long-standing hyperthyroidism Hypogonadism/premature menopause (< 45 years) Cushing’s disease Chronic malnutrition or malabsorption Chronic liver disease Chronic obstructive pulmonary disease (COPD) Chronic inflammatory conditions (e.g., rheumatoid arthritis [RA], inflammatory bowel disease) Drugs associated with reduction in bone density: 2-7 Anticonvulsants Antipsychotic drugs Antiretroviral drugs Aromatase inhibitors Chemotherapeutic/transplant drugs (i.e. cyclosporine, tacrolimus, platinum compounds, cyclophosphamide, methotrexate) Furosemide Glucocorticoids Heparin (long-term) Hormonal/endocrine therapies - Gonadotropin-releasing hormone (GnRH) agonists, luteinizing hormone releasing hormone (LHRH) analogs, depomedroxyprogesterone, excessive thyroid supplementation Methotrexate Selective serotonin reuptake inhibitors Thyroxine (excessive) Proton Pump Inhibitors (PPI) - long-term PPI use has been associated with increased hip fracture risk, as PPIs potentially reduce absorption of calcium carbonate; ensure optimal calcium, vitamin D and nutritional supplementation in these patients, along with the lowest effective PPI dose; consider alternative calciums (ie, calcium citrate) and review periodically References: The Merck Manual online at Last full review/revision December Accessed June 27, 2013. Lee RH, et al. A review of the effect of anticonvulsant medications on bone mineral density and fracture risk. Am J Geriatr Pharmacother 2010;Feb 8(1):34-46. Crews MP, et al. Is antipsychotic treatment linked to low bone mineral density and osteoporosis? A review of the evidence and the clinical implications. Hum Psychopharmacol 2012;Jan 27(1):15-23. Papaioannou A, et al. CMAJ 2010;182: Mayer EL. Early and late long-term effects of adjuvant chemotherapy. Am Soc Clin Oncol Educ Book 2013:9-14. Drinka PJ, et al. Determinants of parathyroid hormone levels in nursing home residents. J Am Med Dir Assoc 2007;Jun 8(5): Targownik LE, et al. Use of proton pump inhibitors and risk of osteoporosis-related fractures. CMAJ 2008;179(4): Wu Q, et al. Selective serotonin reuptake inhibitor treatment and risk of fractures: a meta-analysis of cohort and case-control studies. Osteoporos Int 2012;Jan 23(1): Papaioannou A, et al. CMAJ 2010;182:

21 What are the BENEFITS of Medications?
Reduction of fracture risk by approximately 50% Stabilize or improve bone density HIGH risk patients benefit the most 21

22 What are the RISKS of Medications?
No medication is absolutely safe All drugs have side effects Safe means that benefits of drug therapy outweigh the risks for a person Rare concerning risks: Osteonecrosis of the Jaw (ONJ) Atypical Femur Fracture (AFF) 22

23 Osteoporosis Medication Choices
Anabolic Agent (Bone Forming) Anti-Resorptive (Inhibits Bone Loss) Bisphosphonates Alendronate (Fosamax) Risedronate (Actonel) Zoledronic Acid (Aclasta) Denosumab (Prolia) Raloxifene (Evista) Hormone Therapy (Estrogen) Teriparatide (FORTEO) Medications that we have currently available, in Canada, approved for the treatment of post-menopausal osteoporosis – these are first line medications recommended by OC 2010 Guidelines based on highest quality Grade A evidence from clinical trials. (Note that all bisphosphonate agents, denosumab and teriparatide have been approved for use in men > 50yrs old) 23

24 Bone Remodelling Cycle
Healthy Bone Resorption ≈ Formation Menopause Aging Disease Drugs Resorption > Formation Baron R. Primer on the Metabolic Bone Diseases and Disorders of Mineral Metabolism 6th ed . Adapted from 24

25 Drug Mechanism Denosumab RANK Ligand Inhibitor Raloxifene Estrogen
reduce RANK Ligand Teriparatide PTH Analog Bisphosphonates bind to bone Inhibit osteoclasts Adapted from 25

26 Case Study Questions & Answers

27 Case Objectives Identify indications for bone density testing
Upon completion of this case participants will be better able to: Identify indications for bone density testing Determine the 10-yr fracture risk for patients Order appropriate investigations for secondary causes of osteoporosis Implement effective management plans including pharmacotherapy for osteoporosis Discuss lifestyle, disease and medication factors that affect bone health 27

28 Case 67yo woman Recent wrist fracture after slipped and fell on ice
Past History: Sciatica, Acid reflux, hypothyroidism Medications: L-Thyroxine 0.125mg Omeprazole 20mg Methocarbamol prn, Ibuprofen prn Lorazepam 1mg at bedtime prn Supplements: Vitamin D 1000 IU daily Calcium carbonate 500mg twice a day Recent exacerbation of sciatica Discontinued hormone therapy (estrogen) 2 years ago

29 Question #1 What questions would you ask on history and look for on physical exam to assess her risk for osteoporosis?

30 History and Exam History: Exam: Prior fragility fractures
Prolonged steroid use Height loss > 6 cm historically Current smoking Excess alcohol ≥ 3 units per day Parental hip fracture Falls in past 12 months Other high risk conditions or medications Height loss (>2cm prospectively) Weight (BMI) Low <60 Kg Major loss (≥10% of weight since age 25) Kyphosis Occiput-to wall distance >5cm Rib to pelvis distance >2 FBs Balance and gait Get up and Go Test

31 Importance of Height Loss
Increased risk of vertebral fracture Historical height loss (> 6 cm)1,2 Measured height loss (> 2 cm)3-5 Significant height loss should be investigated by a lateral thoracic and lumbar spine X-ray that includes T4-L4 2/3 of vertebral fractures are asymptomatic Historical height loss (difference between the tallest recalled height and current measured height)1,2 and measured height loss (from two or more office visits)3-5 are associated with the presence of vertebral fractures. Prospective loss of > 2 cm over three years should be investigated by a lateral thoracic and lumbar spine X-ray. References 1. Siminoski K, Warshawski RS, Jen H, et al. The accuracy of historical height loss for the detection of vertebral fractures in postmenopausal women. Osteoporos Int 2006; 17(2): 2. Briot K, Legrand E, Pouchain D, et al. Accuracy of patient-reported height loss and risk factors for height loss among postmenopausal women. CMAJ 2010; 182(6): 3. Moayyeri A, Luben RN, Bingham SA, et al. Measured height loss predicts fractures in middle-aged and older men and women: the EPIC-Norfolk prospective population study. J Bone Miner Res 2008; 23: 4. Siminoski K, Adachi JG, Hanley DA, et al. Accuracy of height loss during prospective monitoring for detection of incident vertebral fractures. Osteoporos Int 2005; 16(4): 5. Kaptoge S, Armbrecht G, Felsenberg D, et al. When should the doctor order a spine X-ray? Identifying vertebral fractures for osteoporosis care: results from the European Prospective Osteoporosis Study (EPOS). J Bone Miner Res 2004; 19: 1. Siminoski K, et al. Osteoporos Int 2006; 17(2): 2. Briot K, et al. CMAJ 2010; 182(6): 3. Moayyeri A, et al. J Bone Miner Res 2008; 23: 4. Siminoski K, et al. Osteoporos Int 2005; 16(4): 5. Kaptoge S, et al. J Bone Miner Res 2004; 19:

32

33 Appropriate Measurement of Height
Use a wall-mounted stadiometer Instructions for subjects: Shoes off Heels, buttocks, and back against the upright board Face directly forward, head stable Record height after exhalation For the most accurate measurement of height, one should use a wall-mounted stadiometer. The patient should be measured without shoes, with the heels, buttocks, and back to an upright board. The subject’s head should face directly forward; the back of the head does not necessarily touch the vertical board. Instruct the patient to take a deep breath, hold it and stand straight. The observer can then apply bilateral pressure to the mastoid processes of the patient to hold the head in position. The patient is then asked to relax and exhale, at which point height can be recorded. Reference: Siminoski K, Jiang G, Adachi JD, et al. Accuracy of height loss during prospective monitoring for detection of incident vertebral fractures. Osteoporos Int 2005; 16(4): Siminoski K, et al. Osteoporos Int 2005; 16(4):

34 Additional Tests for Vertebral Fracture
Rationale Method Interpretation Rib-pelvis distance1 To identify lumbar fractures Measure the distance between the costal margin and the pelvic rim on the mid-axillary line < 2 fingerbreadths is associated with vertebral fractures Occiput-to-wall distance2,3 To help identify thoracic spine fractures Stand straight with heels and back against the wall > 5 cm raises suspicion of vertebral fracture The rationale for measuring rib/pelvis distance is to identify lumbar fractures. This is done by assessment of the distance between the costal margin and the pelvic rim (measured on the mid-axillary line). A measurement of < 2 fingerbreadths is associated with vertebral fractures.1 The occiput-to-wall distance is a tool used to help identify thoracic spine fractures. The measurement is made as the individual stands straight with heels and back against the wall. Vertebral fractures should be suspected if distance between the wall and the occiput is > 5 cm.2,3 References 1. Olszynski WP, Ioannidis G, Sebaldt RJ, et al. The association between iliocostal distance and the number of vertebral and non-vertebral fractures in women and men registered in the Canadian Database For Osteoporosis and Osteopenia (CANDOO). BMC Musculoskeletal Disorders 2002; 3:22. 2. Green AD, Colon-Emeric C, Bastian L, et al. Does this woman have osteoporosis? JAMA 2004; 292(23): 3. Siminoski K, Warshawski R, Jen H, Lee K. Accuracy of physical exam for detection of thoracic vertebral fractures. J Bone Miner Res 2001; 16(Suppl):S274. 1. Olszynski WP, et al. BMC Musculoskeletal Disorders 2002; 3:22. 2. Green AD, et al. JAMA 2004; 292(23): 3. Siminoski K, et al. J Bone Miner Res 2001; 16(Suppl):S274.

35 Rib-Pelvis and Occiput-to-Wall Distances
4 cm 3 FBs 8 cm 12 cm 2 FBs Height loss 3 cm

36 Back to the Case No prior fracture other than recent wrist fracture
No steroids No smoking, rare alcohol intake No parental hip fracture But mother had osteoporotic vertebral fractures 3 falls in the past year 2 cm prospective height loss (presently 171cm) Weight stable – 72 kg No kyphosis, normal pelvic-rib distance and wall-occiput distance Normal get up and go test

37 Question #2 Was her wrist fracture a fragility fracture?

38 Fragility Fracture Yes – fracture occurred with minimal trauma
Definition: Fracture that occurs spontaneously or after minor trauma such as a fall from standing height or less or walking speed or less EXCLUDING craniofacial, hand, ankle and foot fractures Kanis JA, et al. Osteoporos Int 2001; 12(5): Bessette L, et al. Osteoporos Int 2008; 19:79-86.

39 Question #3 Would you order a bone mineral density?
What are the indications for this test?

40 Indications for Baseline BMD
All men & women >65 years Post-menopausal women and men age with: body weight < 60 kg, major weight loss, parental hip fracture, current smoker or high alcohol intake History of fragility fracture (after age 40) Recent prolonged glucocorticoid use ≥ 3 months cumulative use in the past year of prednisone-equivalent dose ≥ 7.5mg daily Other high risk medication use Eg. aromatase inhibitors, anticonvulants, androgen-deprivation Conditions associated with bone loss or fracture Eg. Rheumatoid arthritis, primary hyperparathyroidism, malabsorption syndromes , untreated hyperthyroidism, Cushing’s syndrome

41 Back to the Case She meets indications for baseline BMD Age > 65yo
Fragility fracture

42 Case: Bone Mineral Density
L1-L4 T-score = -2.2

43 Case: Bone Mineral Density
Femoral Neck: T-score = -1.1 Total Hip T-score = -2.0

44 Question #4 Baseline Bone Mineral Density:
L-spine L1-L4 T-score = -3.7 Femoral neck T-score = -1.1 Total Hip T-score = -2.0 What is her absolute 10-yr fracture risk?

45 2010 CAROC Fracture Risk Tool
67-year-old woman femoral neck T-score = -1.1 Based on age & T-score alone = low risk However, had fragility fracture of wrist, thus move to moderate risk Papaioannou A, et al. CMAJ 2010;182:

46 FRAX tool: Online Calculator

47 Back to the Case Her 10-year fracture risk is Moderate (10-20% risk for fracture over the next 10 years) Despite her BMD diagnostic category being osteoporotic (T-score = -3.7 at lumbar spine), she is considered only at moderate risk

48 Question #5 Would you order any further investigations?
If so, which tests?

49 Question #5 Rule out secondary causes:
Calcium, Albumin, Cr, ALP, TSH, CBC 25OH vitamin D Other tests in selective cases (examples): SPEP (if vertebral fracture on xray) Celiac disease screen Lateral thoracolumbar xray (T4-L4) if: Moderate fracture risk based on CAROC or FRAX Prospective height loss > 2 cm Historic height loss > 6 cm Abnormal rib-pelvis or occiput-wall distance

50 Back to the Case Labwork all normal, including 25OHD = 87
Except TSH = 0.15 (low) Thoracolumbar x-ray: No vertebral fracture Degenerative disc disease

51 Question #6 If her spine xray showed an occult vertebral fracture, how would that change her fracture risk? Move to the HIGH risk category

52 Question #7 What recommendations would you make regarding nutrition and exercise as it pertains to bone health: Vitamin D intake Calcium intake Physical activity/exercise

53 Basic Bone Health Basic Bone Health
All patients should be encouraged to follow basic bone health, regardless of fracture risk Basic Bone Health Exercise Strength training 2x/week Balance training or Tai Chi daily ≥30 min aerobic physical activity daily Walking is not enough without strength or balancing training Encourage attention to posture, and exercises for back extensor muscles daily Calcium Total daily intake through diet and supplements should be 1200 mg Vitamin D Supplementation 400 to 1000 IU for adults under age 50 without osteoporosis or conditions affecting vitamin D absorption. 800 to 2000 IU for adults over 50 Individuals with osteoporosis should participate in exercises to increase muscle strength at least twice daily, and exercises to improve balance daily – the best evidence we have supports multicomponent exercise programs that combine strength, balance and aerobic training. In fact, programs that included only walking were not as effective for preventing falls, and did not have an effect on hip bone mineral density. All older adults should achieve at least 30 minutes a day of moderate to vigorous intensity aerobic physical activity, but those with spine fractures should aim for moderate, and not vigorous activity. To prevent spine fractures, she could perform exercises to improve back extensor muscle endurance, and pay attention to alignment during daily activities. Instead of telling her not to bend or twist, teach her how to do a hip hinge or step-to-turn. She can use these techniques to modify activities that involve flexion or twisting of the spine. Papaioannou A, et al. CMAJ 2010;182: Giangregorio LM, et al. Osteoporos Int 2014; 25: 53

54 Osteoporosis Exercise Guide
Consider functional capacity, history of activity, preferences and fracture risk in discussion of exercise type and duration. Exercise Frequency Examples/Comments Strength Training ≥ 2x/week Exercises for legs, arms, chest, shoulders, back Use body weight against gravity, bands, weights* 8-12 repetitions maximum per exercise Balance Training ~ 20mins daily Standing still: one-leg stand, semi-tandem stance, shift weight between heels and toes while standing Dynamic movements: Tai Chi, tandem walking, dancing Aerobic physical activity ≥ 5x/week (30min/day) Do bouts of 10 min or more Accumulate ≥ 30 min per day Moderate- or vigorous-intensity* Posture/ Back Extensor Training 5-10mins daily Lie face up on firm surface, knees bent, feet flat. Use pillow if head doesn’t reach floor. Do this 5-10 min/day Progress to supine lying with gentle head press, perform 3-5 seconds “holds” Spine Sparing Strategies During daily activities Modify activities that flex (bending forward) or twist the spine Teach the “hip hinge” and “step to turn” techniques To ensure your patients understand the importance of strength and balance exercises, suggest options for how to get started, like attending an exercise class that includes strength and balance training, or consulting a physio or kinesiologist for a home exercise program. Bonefit.ca has a locator to identify physiotherapists, kinesiologists and exercise instructors in various communities that are Bone Fit trained. The Y or other community support services may offer exercise classes or services locally. Some are free, so take advantage of these resources. Detailed information about the types of exercises she should do are available on videos, webinars, webpages and handouts from Osteoporosis Canada. *In presence of vertebral fracture, consult physiotherapist/kinesiologist if using weights. Emphasize moderate over vigorous intensity aerobic activity Locate a Bone Fit trained instructor: English: / French: or

55 Teach the patient to place her hands in the crease where her legs meet her torso, near the groin, and bend at the hips, over her hands, while sticking her bottom out and bending her knees. Teach patient to flex at hips and knees while bringing hips posterior to the base of support and maintaining head over the base of support, so they can modify activities that require forward bending.

56 Vitamin D: Optimal Levels
To consistently improve clinical outcomes such as fracture risk, an optimal serum level of hydroxy vitamin D is probably > 75 nmol/L For most Canadians, supplementation is needed to achieve this level The optimal level of serum 25OH-D for musculoskeletal benefits is estimated to be at least 75 nmol/L.6 Reference Hanley DA, Cranney A, Jones G, et al. Vitamin D in adult health and disease: a review and guideline statement from Osteoporosis Canada. CMAJ 2010; 182:E610-E618. Hanley DA, et al. CMAJ 2010; 182:E610-E618.

57 Serum 25-hydroxy vitamin D
When to Measure Serum 25-hydroxy vitamin D In situations where deficiency is suspected or where levels would affect response to therapy Individuals with impaired intestinal absorption Patients with osteoporosis requiring pharmacotherapy Should be checked no sooner than three months after commencing or changing an adequate supplementation dose Monitoring of routine supplement use and routine screening of otherwise healthy individuals are not necessary Serum 25-OH-D should only be measured in situations where deficiency is suspected, or would affect response to therapy; e.g., individuals with impaired intestinal absorption or in patients with osteoporosis requiring pharmacologic therapy. The half-life of 25-OH-D in the body is 15 – 20 days1 and the serum 25-OH-D response to standard-dose supplementation plateaus after three to four months.2 Therefore, serum 25-OH-D should be checked no sooner than three months after commencing standard-dose supplementation in patients who have osteoporosis. Monitoring of routine supplement use and routine testing of otherwise healthy individuals as a screening procedure are not necessary.3 References 1. Jones G. Pharmacokinetics of vitamin D toxicity. Am J Clin Nutr 2008; 88(2):582S-586S. 2. Heaney RP, Davies KM, Chen TC, et al. Human serum 25-hydroxycholecalciferol response to extended oral dosing with cholecalciferol. Am J Clin Nutr 2003; 77(1): 3. Hanley DA, Cranney A, Jones G, et al. Vitamin D in adult health and disease: a review and guideline statement from Osteoporosis Canada. CMAJ 2010; 182:E610-E618. Hanley DA, et al. CMAJ 2010; 182:E610-E618.

58 Question #8 When is pharmacotherapy indicated?
Does this patient warrant pharmacotherapy?

59 Who requires medication?
Based on 10-year Fracture Risk: LOW: NO Treatment MODERATE: Risk factors??? HIGH: YES – OP Rx

60 Question #8 Does she warrant pharmacotherapy?
Factors to consider in moderate risk patients: wrist fracture >age 65 or with T-score ≤ -2.5 spine T-score much lower vs femoral neck T-score rapid bone loss (eg. recent discontinuation of HRT) recurrent falls (≥ 2 falls in past 12 months) long-term or repeated systemic steroid use that does not meet conventional criteria other conditions or medications associated with osteoporosis or bone loss

61 Back to the Case Treatment may be reasonable for this patient:
wrist fracture >age 65 or with T-score ≤ -2.5 spine T-score much lower vs femoral neck T-score rapid bone loss (eg. recent discontinuation of estrogen hormone therapy) recurrent falls (≥ 2 falls in past 12 months)

62 Question #9 What are her treatment options?
Which one would you recommend?

63 Osteoporosis Medication Choices
Anabolic Agent (Bone Forming) Anti-Resorptive (Inhibits Bone Loss) Bisphosphonates Alendronate (Fosamax) Risedronate (Actonel) Zoledronic Acid (Aclasta) Denosumab (Prolia) Raloxifene (Evista) Hormone Therapy (Estrogen) Teriparatide (FORTEO) Medications that we have currently available, in Canada, approved for the treatment of post-menopausal osteoporosis – these are first line medications recommended by OC 2010 Guidelines based on highest quality Grade A evidence from clinical trials. (Note that all bisphosphonate agents, denosumab and teriparatide have been approved for use in men > 50yrs old) 63

64 First Line Therapies with Evidence for Fracture Prevention in Postmenopausal Women*
Type of Fracture Antiresorptive therapy Bone formation therapy Bisphosphonates Denosumab Raloxifene Hormone therapy (Estrogen)** Teriparatide Alendronat e Risedronate Zoledronic acid Vertebral Hip - Non- vertebral+ * For postmenopausal women,  indicates first line therapies and Grade A recommendation. For men requiring treatment, alendronate, risedronate, and zoledronic acid can be used as first line therapies for prevention of fractures [Grade D]. + In clinical trials, non-vertebral fractures are a composite endpoint including hip, femur, pelvis, tibia, humerus, radius, and clavicle. ** Hormone therapy (estrogen) can be used as first line therapy in women with menopausal symptoms. Papaioannou A, et al. CMAJ 2010;182:

65 Question #9 Which therapy would you recommend for this patient?
An oral bisphosphonate – longest experience sc denosumab or iv bisphosphonate if parenteral option preferred due to gastrointestinal issues or adherence concerns Raloxifene also acceptable but no hip fracture prevention HT (Estrogen) if has intolerable menopausal symptoms Teriparatide is another parenteral option and the only bone-forming agent available, however may not first choice in this case

66 Question #10 How would you counsel her on oral bisphosphonate therapy in terms of how to take the medication (technique), and the benefits versus risks?

67 Oral Bisphosphates: Administration Instructions (poor bioavailability)
Take in the AM on an empty stomach at least hour before breakfast / other medications Avoid for 2-3 hours: Dairy products / other Ca2+ foods Calcium supplements Multivitamin / mineral supplements Drink at least 250ml of plain water Do NOT lie down / Stay upright x 30min

68 Oral Bisphosphonates: Side Effects
monitor for heartburn/GERD Upper /Lower GI: local irritation to the mucosa muscle, bone, joint aches/pains MSK More likely with Risedronate 150mg/monthly 24-48hr onset, for ~3-4 days fever, muscle/joint aches, tiredness Can take Acetaminophen or Ibuprofen for symptom relief Acute-Phase reaction

69 Bisphosphonates – Rare Risks
Exposed bone in jaw > 8 weeks (with no radiotherapy history) 1 in 100,000 patient-years Unclear mechanism Risk factors: high dose iv bisphosphonate use in cancer patients, poor dental hygiene or infection, dental surgery Osteonecrosis of the Jaw (ONJ) Unusual fracture of femur with no or minimal trauma Associated with long-term bisphosphonate use 2 to 78 cases in 100,000 patient-years Monitor for prodrome of thigh/groin pain Atypical Femur Fractures (AFF) Brown JP, et al. CFP 2014; 60:

70 Atypical Femur Fracture (AFF)
Shane E, et al. JBMR 2014; 29:1- 24 70

71 Brown JP, et al. CFP 2014; 60:

72 Question #11 What other recommendations would you make to reduce her risk of falls and fractures?

73 Back to the Case Fall prevention strategies (home safety, occupational therapy assessment) Identify medications that may affect bone health and fall risk Reduce thyroxine dose (over-replaced, TSH was low) Try limit drugs that may cause drowsiness/imbalance (Methocarbamol, Lorazepam, Codeine) Reassess proton-pump inhibitor use (PPI) - consider alternative such as H2-blocker PPI shown to be associated with increased risk for osteoporotic fractures Targownik LE, et al. CMAJ 2008;179:

74 Medications and Risk of Falls
Medications taken for….. Sleep Mood/Behaviour Anxiety Depression Hypertension Allergies Pain Muscle spasms …may impair BALANCE, CO-ORDINATION, VISION; may cause DIZZINESS, DROWSINESS or HYPOTENSION; may  CONFUSION, FORGETFULNESS…

75 Multidisciplinary Approach

76 Question #12 Patient was started on Risedronate 35 mg once weekly.
What would you consider a positive response to therapy?

77 Question #12 What is considered a positive response to treatment?
No new fragility fractures Stable or improved bone density If deterioration in bone density or ongoing fractures – consider poor adherence to medication, unrecognized secondary cause, or treatment failure

78 Question #13 What strategies can improve adherence to medication and healthy bone lifestyle? Patient education of benefits versus risks Including the imposed risks with no treatment and potential effect on quality of life from fractures Expectations with positive response Address patient questions/concerns & preferences Individualized approach Informed and shared decision making Regular reassessments of fracture risk, benefit-to-risk ratio, and monitoring for side effects

79 Informed and Shared Decision Making
Individualize treatment based on patient and drug characteristics What is the patient’s 10-yr fracture risk? Do the benefits outweigh the risks? Patient preference based on pros versus cons Prior drug experience, response & side effects Convenience and adherence factors Cost/affordability 79

80 Summary Bone density testing in the appropriate clinical context
BMD assesses only bone quantity (Bone strength = bone quantity + bone quality) Must determine the 10-yr Fracture Risk High risk  Treatment recommended Moderate risk  Consider other factors to guide treatment Low risk No treatment Many treatment options with pros & cons Medications significantly reduce fracture risk Patient education important to improve adherence Optimize lifestyle factors and limit risks of falls

81 Useful References: Osteoporosis Canada website and slide kit:
WHO FRAX tool website: 2010 Clinical Practice Guidelines for the diagnosis and management of osteoporosis in Canada: Summary: Papaioannou A et al., CMAJ 2010:182: 1864

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