2010 Guidelines Case Study #1 Mrs. DT 2010 Guidelines.

2010 Guidelines2010 Guidelines

Case Study #1Case Study #1Mrs. DTMrs. DT

2010 Guidelines


Case PresentationCase Presentation

• Age 59: nine years post-menopause with treated osteoporosis

• Has always enjoyed excellent health with no past medical or surgical history

• Comes in for her periodic health exam— concerned about calcium and cardiovascular risk


Physical ExaminationPhysical Examination

• Height = 154 cm (60.5 in.)

• Weight = 55.5 kg (122 lbs.)

• No significant changes in height, weight, posture, or gait from previous visits– Changes in height and weight can be signs

of vertebral fractures


MedicationsMedications

• Risedronate 35 mg weekly for past six years

• Calcium 600 mg + vitamin D 400 IU (single-tablet supplement)


History of Osteoporosis:History of Osteoporosis:T-scores and Treatment DecisionsT-scores and Treatment Decisions

Age BMD T-scores Action taken

53 Spine: -1.8Femoral neck: -2.4

Ruled out secondary causes of osteoporosisInitiated risedronate 35 mg weeklyEducated on importance of dietary calciumInitiated calcium 1500 mg dailyInitiated vitamin D 400 IU daily


Current Risk Factor AssessmentCurrent Risk Factor Assessment

• Non-smoker, no regular alcohol consumption• No previous history of fracture• No parental history of hip fracture• No history of systemic glucocorticoid use• No comorbidities• Diet rich in calcium (1200 mg daily from foods)• High caffeine intake


QuestionQuestion

• Were the diagnosis and treatment initiation in line with today's guideline recommendations?


Reflections on theReflections on theDecision-making ProcessDecision-making Process

• Previous diagnosis and treatment decisions were largely based on bone density T-scores

• 2010 osteoporosis guidelines advocate making decisions based on an assessment of overall 10-year fracture risk

• Tools endorsed: CAROC and FRAX

• Current recommendations for:– Calcium: 1200 mg from diet and supplement combined– Vitamin D: 800 – 2000 IU daily for age over 50


Should This Patient Have Been Receiving Should This Patient Have Been Receiving Treatment? FRAX 10-year Risk AssessmentTreatment? FRAX 10-year Risk Assessment

Age BMD FRAX-calculated 10-year risk

53 Spine: -1.8Femoral neck: -2.4

6.0% for major osteoporotic fracture


FRAX Calculation of Original RiskFRAX Calculation of Original Risk(Age 53 – Six Years Ago)(Age 53 – Six Years Ago)


Mrs. DT: Reflection on DiagnosisMrs. DT: Reflection on Diagnosis

• Six years ago, the diagnosis and therapy were appropriate, given the low BMD at the femoral neck (-2.4) and two minor risk factors (weight < 57kg, high caffeine intake)

• With today's tools (e.g., CAROC, FRAX), however, Mrs. DT would have been low risk – Treatment would not have been recommended

under the current system


QuestionQuestion

• Would you consider using a risk-assessment tool to check Mrs. DT's current level of risk on treatment?


Absolute Fracture Risk ToolsAbsolute Fracture Risk Tools

• Calculate risk for treatment-naïve patients only• Cannot be used to monitor response to therapy• Using CAROC or FRAX in a patient on therapy only

reflects the theoretical risk of a hypothetical patient who is treatment naïve and does not reflect the risk reduction associated with therapy

• One could use these tools to assess what the risk might

be for a woman like Mrs. DT who had never been treated


FRAX Calculation of Risk for a Woman Like FRAX Calculation of Risk for a Woman Like Mrs. DT, but Who Had Never Been TreatedMrs. DT, but Who Had Never Been Treated


QuestionQuestion

• What would you do in this case? • Would you continue or discontinue treatment

with risedronate?– Discuss the rationale for your decision


Mrs. DT: ConclusionsMrs. DT: Conclusions

• Diagnosis and treatment decisions should now be based on 10-year assessment of risk using a validated tool– Patients at low risk (10-year risk < 10%) should not be

receiving treatment

• Her current risk level is not known:– 10-year absolute risk tools were developed to assess patients

who are treatment naive

• Mrs. DT currently gets adequate calcium from her diet (~1200 mg daily)– Calcium supplementation should be stopped– Vitamin D supplementation should continue


Case 1 Case 1 – – Mrs. DT

Back-up MaterialBack-up MaterialAdditional slides that can be accessed from hyperlinks on case slides


Potential Risks of Calcium Potential Risks of Calcium SupplementationSupplementation

• High-dose calcium supplementation has been associated with– Renal calculi in older women

– Cardiovascular events in older women– Prostate cancer in older men

1. Bolland MJ, et al. J Clin Endocrinol Metab 2010; 95(3):1174-1181.2. Bolland MJ, et al. BMJ 2008; 336(7638):262-266.

3. Reid IR, et al. Osteoporos Int 2008; 19(8):1119-1123.Return to case


Importance of WeightImportance of Weight

• In men > 50 years and in postmenopausal women, the following are associated with low BMD and fractures– Low body weight (< 60 kg)– Major weight loss (> 10%

of weight at age 25)

1. Papaioannou A, et al. Osteoporos Int 2009; 20(5):703-715.2. Waugh EJ, et al. Osteoporos Int 2009; 20:1-21.

3. Cummings SR,et al. N Engl J Med 1995; 332(12):767-773.4. Papaioannou A, et al. Osteoporos Int 2005; 16(5):568-578.

5. Kanis J, et al. Osteoporos Int 1999; 9:45-54.6. Morin S, et al. Osteoporos Int 2009; 20(3):363-70.Return to case


Importance of Height LossImportance 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 spineX-ray

1. Siminoski K, et al. Osteoporos Int 2006; 17(2):290-296.2. Briot K, et al. CMAJ 2010; 182(6):558-562.

3. Moayyeri A, et al. J Bone Miner Res 2008; 23:425-432.4. Siminoski K, et al. Osteoporos Int 2005; 16(4):403-410.

5. Kaptoge S, et al. J Bone Miner Res 2004; 19:1982-1993.Return to case


First Line Therapies with Evidence for Fracture First Line Therapies with Evidence for Fracture Prevention in Postmenopausal Women* Prevention in Postmenopausal Women*

Type of Fracture

Antiresorptive therapyBone

formation therapy

Bisphosphonates

Denosumab RaloxifeneHormone therapy

(Estrogen)**Teriparatide

Alendronate RisedronateZoledronic

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.

Return to case


10-year Risk Assessment: CAROC10-year Risk Assessment: CAROC

• Semiquantitative method for estimating 10-year absolute risk of a major osteoporotic fracture* in postmenopausal women and men over age 50– Stratified into three zones (Low: < 10%, moderate,

high: > 20%)

• Basal risk category is obtained from age, sex, and T-score at the femoral neck

• Other fractures attributable to osteoporosis are not reflected; total osteoporotic fracture burden is underestimated

Siminoski K, et al. Can Assoc Radiol J 2005; 56(3):178-188.

* Combined risk for fractures of the proximal femur, vertebra [clinical], forearm, and proximal humerus


10-year Risk Assessment for Women 10-year Risk Assessment for Women (CAROC Basal Risk)(CAROC Basal Risk)

Papaioannou A, et al. CMAJ 2010 Oct 12. [Epub ahead of print].


10-year Risk Assessment for Women 10-year Risk Assessment for Women (CAROC Basal Risk)(CAROC Basal Risk)

Age Low Risk Moderate Risk High Risk

50 above -2.5 -2.5 to -3.8 below -3.8

55 above -2.5 -2.5 to -3.8 below -3.8

60 above -2.3 -2.3 to -3.7 below -3.7

65 above -1.9 -1.9 to -3.5 below -3.5

70 above -1.7 -1.7 to -3.2 below -3.2

75 above -1.2 -1.2 to -2.9 below -2.9

80 above -0.5 -0.5 to -2.6 below -2.6

85 above +0.1 +0.1 to -2.2 below -2.2



10-year Risk Assessment for Men 10-year Risk Assessment for Men (CAROC Basal Risk)(CAROC Basal Risk)



10-year Risk Assessment for Men 10-year Risk Assessment for Men (CAROC Basal Risk)(CAROC Basal Risk)


Age Low Risk Moderate Risk High Risk

50 above -2.5 -2.5 to -3.9 below -3.9

55 above -2.5 -2.5 to -3.9 below -3.9

60 above -2.5 -2.5 to -3.7 below -3.7

65 above -2.4 -2.4 to -3.7 below -3.7

70 above -2.3 -2.3 to -3.7 below -3.7

75 above -2.3 -2.3 to -3.8 below -3.8

80 above -2.1 -2.1 to -3.8 below -3.8

85 above -2.0 -2.0 to -3.8 below -3.8


Risk Assessment with CAROC: Risk Assessment with CAROC: Important Additional Risk FactorsImportant Additional Risk Factors

• Factors that increase CAROC basal risk by one category (i.e., from low to moderate or moderate to high)– Fragility fracture after age 40*1,2

– Recent prolonged systemic glucocorticoid use**2

1. Siminoski K, et al. Can Assoc Radiol J 2005; 56(3):178-188.2. Kanis JA, et al. J Bone Miner Res 2004; 19(6):893-899.Return to case

* Hip fracture, vertebral fracture, or multiple fracture events should be considered high risk** >3 months use in the prior year at a prednisone-equivalent dose ≥ 7.5 mg daily


Risk Assessment Using FRAXRisk Assessment Using FRAX

• Uses age, sex, BMD, and clinical risk factors to calculate 10-year fracture risk– BMD must be femoral neck

– FRAX also computes 10-year probability of hip fracture alone

• This system has been validated for use in Canada1

• There is an online FRAX calculator with detailed instructions at: www.shef.ac.uk/FRAX

1. Leslie WD, et al. Osteoporos Int; In press.

* composite of hip, vertebra, forearm, and humerus


FRAX Tool: Online CalculatorFRAX Tool: Online Calculator

www.shef.ac.uk/FRAX.


FRAX Clinical Risk FactorsFRAX Clinical Risk Factors

• Parental hip fracture• Prior fracture• Glucocorticoid use• Current smoking• High alcohol intake• Rheumatoid arthritis

Return to case


Recommended Vitamin D Recommended Vitamin D SupplementationSupplementation

GroupRecommended

Vitamin D Intake (D3)

Adults < 50 without osteoporosis or conditions affecting vitamin D absorption

400 – 1000 IU daily(10 mcg to 25 mcg

daily)

Adults > 50 or high risk for adverse outcomes from vitamin D insufficiency (e.g., recurrent fractures or osteoporosis and comorbid conditions that affect vitamin D absorption)

800 – 2000 IU daily(20 mcg to 50 mcg

daily)

Hanley DA, et al. CMAJ 2010; Jul 26. [epub before print].


Vitamin D: Optimal LevelsVitamin D: Optimal Levels

• To most consistently improve clinical outcomes such as fracture risk, an optimal serum level of 25-hydroxy vitamin D is probably > 75 nmol/L– For most Canadians,

supplementation is needed to achieve this level

Hanley DA, et al. CMAJ 2010; 182:E610-E618.


When to Measure Serum 25-OH-DWhen to Measure Serum 25-OH-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 standard-dose supplementation in osteoporosis

• Monitoring of routine supplement use and routine screening of otherwise healthy individuals are not necessary

Hanley DA, et al. CMAJ 2010; 182:E610-E618.Return to case


Recommended Calcium IntakeRecommended Calcium Intake

• From diet and supplementscombined: 1200 mg daily– Several different types of calcium

supplements are available

• Evidence shows a benefit ofcalcium on reduction of fracturerisk1

• Concerns about serious adverse effects with high-dose supplementation2-4

1. Tang BM, et al. Lancet 2007; 370(9588):657-666.2. Bolland MJ, et al. J Clin Endocrinol Metab 2010; 95(3):1174-1181.

3. Bolland MJ, et al. BMJ 2008; 336(7638):262-266.4 Reid IR, et al. Osteoporos Int 2008; 19(8):1119-1123.Return to case

2010 Guidelines Case Study #1 Mrs. DT 2010 Guidelines.

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