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

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2010 Guidelines

Case Study #1Mrs. DT


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Case 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


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Physical 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


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Medications

  • Risedronate 35 mg weekly for past six years

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


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History of Osteoporosis:T-scores and Treatment Decisions


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Current 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


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Question

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


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Reflections on theDecision-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


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


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


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Mrs. 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


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Question

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


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Absolute 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



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Question Had Never Been Treated

  • What would you do in this case?

  • Would you continue or discontinue treatment with risedronate?

    • Discuss the rationale for your decision


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Mrs. DT: Conclusions Had Never Been Treated

  • 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


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Back-up Material Had Never Been Treated

Additional slides that can be accessed from hyperlinks on case slides

Case 1 – Mrs. DT


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Potential Risks of Calcium Had Never Been TreatedSupplementation

  • High-dose calcium supplementation has been associated with

    • Renalcalculi 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.

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Importance of Weight Had Never Been Treated

  • 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.

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Importance of Height Loss Had Never Been Treated

  • 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.

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First Line Therapies with Evidence for Fracture Had Never Been TreatedPrevention in Postmenopausal Women*

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* 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.


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10-year Risk Assessment: CAROC Had Never Been Treated

  • 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

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

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


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10-year Risk Assessment for Women (CAROC Basal Risk) Had Never Been Treated

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


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10-year Risk Assessment for Women (CAROC Basal Risk) Had Never Been Treated

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


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10-year Risk Assessment for Men (CAROC Basal Risk) Had Never Been Treated

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


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10-year Risk Assessment for Men (CAROC Basal Risk) Had Never Been Treated

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


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Risk Assessment with CAROC: Had Never Been TreatedImportant 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

* 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

  • 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.

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Risk Assessment Using FRAX Had Never Been Treated

  • 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

  • * composite of hip, vertebra, forearm, and humerus

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


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FRAX Tool: Online Calculator Had Never Been Treated

  • www.shef.ac.uk/FRAX.


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FRAX Clinical Risk Factors Had Never Been Treated

  • Parental hip fracture

  • Prior fracture

  • Glucocorticoid use

  • Current smoking

  • High alcohol intake

  • Rheumatoid arthritis

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Recommended Vitamin D Supplementation Had Never Been Treated

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


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Vitamin D: Optimal Levels Had Never Been Treated

  • 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.


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When to Measure Serum 25-OH-D Had Never Been Treated

  • 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

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


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Recommended Calcium Intake Had Never Been Treated

  • From diet and supplementscombined: 1200 mg daily

    • Several different types of calciumsupplements 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.

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