Osteoporosis amgen meeting

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Osteoporosis amgen meeting

  1. 1. Conquering Challenges in Osteoporosis Management & Treatment Dr Larry Dian Division Of Geriatric Medicine, U.B.C. 1
  2. 2. Faculty/Presenter Disclosure » Faculty: DR Larry Dian » Relationships with commercial interests: – Grants/Research Support: Amgen, Lilly – Speakers Bureau/Honoraria: Novartis, Pfizer, Merck, Warner Chilcott – Consulting Fees: Merck. 3
  3. 3. Disclosure of Commercial Support » This program has received financial support from Amgen Canada in the form of an educational grant » This program has received in-kind support from Amgen Canada in the form of material production and logistical support » Potential for conflict(s) of interest: – Dr Larry Dian has received an honoraria funding from Amgen Merck, Warner Chilcott, Eli Lilly, Novartis, whose product(s) are being discussed in this program] – Amgen developed and distributes denosumab ® a product that will be discussed in this program: denosumab (Prolia) 4
  4. 4. Mitigating Potential Bias » Bias has be mitigated by the following: – All program content was developed and peer-reviewed by an independent physicians steering group – All clinical recommendations are based on clinical guidelines and peer-reviewed evidence – The program has been to developed to improve PMO patient outcomes by increased screening and appropriate monitoring of patients at risk for fracture based on national needs assessment criteria – Industry has not been involved in the development of the program 5
  5. 5. Audience Question » Do you feel confident assessing fracture risk in women with post-menopausal osteoporosis (PMO)? A. Very confident B. Confident C. Somewhat Confident D. Not Confident 6
  6. 6. Learning Objectives Upon completion of this session, participants will be able to implement strategies and action steps to: Effectively identify patients at high risk for fracture Implement PMO management plans Use evidenced based medicine to optimize treatment for patients with PMO Overcome challenges in PMO management 7
  7. 7. Agenda Burden of Osteoporosis 5 minutes Identifying Patients at High Risk for Fracture 10 minutes Optimizing Treatment for PMO Patients 20 minutes Challenges in Managing Patients on Treatment 15 minutes Clinical Pearls & Question & Answer 10 minutes 8
  8. 8. Audience Question » Which of the following is most common in women over 50 years of age in Canada? A. Heart Attack B. Breast Cancer C. Stroke D. Osteoporotic Fracture 9
  9. 9. Burden of Osteoporosis 10
  10. 10. Prevalence of Fractures in Canada » Fractures from osteoporosis in Canadian women are more common than heart attack, stroke and breast cancer combined1 Annual incidence of common diseases 200,000 153,400 150,000 80,000 40,000 41,500 Other 38,900 Vertebral 32,700 Wrist 49,220 29,874 30,000 Hip* 0 22,700 10,300 Pelvis Osteoporotic Heart fractures1,2 Attack3 Stroke3 Breast Cancer4 *Canadian †Other hip fractures from (1); Non-hip fracture data extrapolated from (2). represents non-osteoporotic fractures sites (humerus, clavicle, hands/fingers, patella, tibia, fibula). 2 1. Leslie WD, et al. Osteoporos Int . 2010; 21:1317‐1322; 2. Burge J, et al. J Bone Miner Res. 2007;22:465-475; 3. Canadian Institute for Health Information (2009) Health Indicators. ; 4. Canadian Cancer Society. 2009. 11
  11. 11. Why is this Important to Family Physicians? Osteoporosis is managed primarily by Family Practice in Canada • Based on Canadian prescriptions of osteoporosis therapies Source: IMSB, Compuscript (Aug’11) 12
  12. 12. Only 15% of Patients are Treated After an Osteoporotic Fracture Percentage of patients (%) A fracture is to osteoporosis what a heart attack is to cardiovascular disease 100% How do we shift this paradigm? 80% 60% 80% 40% 20% 15% 0% Osteoporosis Treatment Post Fracture1 Beta Blockers Post Heart Attack2 A history of fracture is the strongest predictor of new fractures, yet post-fracture treatment rates remain low 1. Bessette L, et al. Osteoporos Int. 2008;19:79-86. 2. Austin PC, et al. CMAJ. 2008;179:895-900. 13
  13. 13. What are the Consequences of Underdiagnosing and Undertreating Osteoporosis? In women with hip fracture: Fracture begets future fracture Deteriorated quality of life 40% had 40% need prior fracture1 assistance walking2 Long-term care admission 18% enter LTC3 Mortality 23% die within 1 year4 • Lifetime risk of hip fracture in women >50 is 12.1%5 1. Hajcsar EE, et al. CMAJ 2000, 163:819-822.; 2. Cooper C. Am J Med. 1997:103:12S-19S; 3. Jean et al . JBMR 2012 On-line September 2012. 4. Ioannidis G, et al. CMAJ 2009;181: 265-271. 5. Hopkins et al – Osteo Intl 2012; 23:921-927 14
  14. 14. Identifying Patients at High Risk for Fracture 15
  15. 15. Learning Objective  Effectively identify patients at high risk for fracture. 16
  16. 16. Audience Question » Is a BMD T-score of -2.5 sufficient to diagnose osteoporosis? A. Yes B. No C. Maybe 17
  17. 17. Understanding Fragility Fracture: Key to Appropriate Patient Management BMD vs. Osteoporotic Fracture Rates/Number Fracture Rate Fracture rate per 1000 person-years 400 No of Fractures 50 450 350 300 40 30 60% of women with fragility fractures have non-osteoporotic bone mineral density (T-score >-2.5) 250 200 150 20 No of Fractures BMD distribution 60 100 10 50 0 >1.0 0.5 to 0.0 1.0 to 0.5 –0.5 to –1.0 0.0 to –0.5 –1.5 to –2.0 –1.0 to –1.5 –2.5 to –3.0 –2.0 to –2.5 < –3.5 0 –3.0 to –3.5 BMD T-scores Adapted from Siris ES, et al: JAMA 2001; 286:2815-22. 18
  18. 18. When Screening Remember... What is the Call to Action? It's Less than 2 minutes that Pay Off! Question : “Since the last visit..." – " Have you broken any bones? " – " Have you fallen? " – " Have you had prolonged and unusual back pain? " – " Have you received oral or intravenous steroids (cortisone) " Look - Is there kyphosis? - Ability to perform the “Get up and Go” Test Measure the patient’s height EMR reminder tools may help to prompt screening4 1. Siminoski K et al. Osteoporos Int. 2006;17:290-6. 2. Papaioannou A, et al CMAJ 2010. 3. Timed Up-and-go test. Available at: http://www.saskatoonhealthregion.ca/pdf/03_Timed%20Up%20and%20Go%20procedure.pdf. 4. Loo TS et al. Arch Intern Med 19
  19. 19. Screening for osteoporosis: When to do a BMD1 Aged ≥ 65 years Everyone Aged 50-64 years Aged <50 years One or more risk factors for 2°causes of osteoporosis (i.e. malabsorption) fracture: o o o o o o Fragility fracture after 40 Parental hip fx Medication with high risk of bone loss (i.e. steroids) Smoking, alcohol (≥3/d) Disorders associated with osteoporosis (i.e. RA) Low weight or major weight loss Prior fragility fracture Medication with high risk of bone loss Clinical Note: If you are ordering unrelated imaging (e.g. chest x-ray) for your patient, consider adding “rule out vertebral fracture” on the order. 1. Papaioannou A, et al CMAJ 2010. 20
  20. 20. There are Two Tools Available for Fracture Risk Assessment These tools incorporate other risk factors for fracture in addition to BMD 1. OC Guidelines tool available at: http://www.osteoporosis.ca/multimedia/FractureRiskTool/index.html#/Home 2. FRAX® tool available at: http://www.shef.ac.uk/FRAX/tool.jsp 3. National Osteoporosis Foundation guidelines: www.nof.org/professionals/NOF_Clinicians_Guide.pdf 21
  21. 21. Calculating 10-Year Absolute Fracture Risk for Postmenopausal Women: CAROC 10-year absolute fracture risk in treatment naïve women combining femoral neck T-score and age1 Increases to the next risk category 0.0 Prior fragility fracture after age 40 Prolonged corticosteroid therapy* Femoral Neck T-score -0.5 -1.0 Low Risk -1.5 < 10% -2.0 -2.5 Moderate Risk -3.0 10%–20% -3.5 Prior hip or vertebral fracture, or >1 nonvertebral fragility fracture High Risk >20% -4.0 50 55 60 65 70 75 80 85 Age (years) Lumbar spine or total hip T-score ≤ -2.5: consider the individual to be at least at moderate risk Calibrated using Canadian fracture data and have been directly validated in Canadians 2 *At least three months cumulative use during the preceding year at a prednisone-equivalent dose ≥ 7.5 mg daily 1. Papaioannou A, et al. CMAJ. 2010;182:1864-1873. 2. Leslie WD, et al. J Bone Miner Res. 2009;24:353-360. 22
  22. 22. Medications known to cause/accelerate bone loss • • • • Anticonvulsants Antipsychotic drugs Aromatase inhibitors Chemotherapeutic/transplant drugs • Furosemide • Hormonal/endocrine therapies (GnRH, agonists, LHRH analogs) • Proton Pump Inhibitors (PPI) • Selective serotonin reuptake inhibitors (SSRIs) Conditions and medications that increase the risk of falling, potentially fracturing Benzodiazepines, narcotics, neuroleptics, any anticholinergic Cognitive impairment, confusion, sedation, drowsiness Anticonvulsants, antidepressants, antihypertensives, benzodiazepines, narcotics Dizziness, orthostatic hypotension Antidepressants, metoclopramide, neuroleptics Gait abnormalities, Beta-blockers, nitrates, vasodilators Syncope Neuroleptics, anticholinergics Visual Disturbances (blurring) 23
  23. 23. Optimizing Treatment for PMO Patients 24
  24. 24. Learning Objectives  Implement PMO management plans.  Use evidenced based medicine to optimize treatment for patients with PMO. 25
  25. 25. Treatment Guidelines: The Challenge of the Moderate Risk Patient Low risk (<10%) Moderate risk High risk (>20%) Papaioannou A, et al. CMAJ. 2010;182:1864-1873. Lifestyle Modification ? Lifestyle Treat Treat 26
  26. 26. Top 5 Reasons to Consider Treatment in the Moderate Risk Patient: 1. Fracture: vertebral (on lateral spine X-ray) or wrist fracture (in patient >65 or BMD ≤ -2.5) 2. Lumbar spine T-score << femoral neck T-score (by >2 T-scores) 3. Concurrent high risk disorder or medications, including: • • • • • • Hypogonadism or premature menopause (age <45 yr) Primary hyperparathyroidism Hyperthyroidism Rheumatoid arthritis Glucocorticoids (long-term or repeated use) Aromatase inhibitor therapy 4. Falls (≥2 in the past year) 5. Patient preference to be treated Steering Group Communications. Feb 9th, 2012. Based on Osteoporosis Canada Guidelines: Papaioannou A, et al. CMAJ. 2010;182:1864-1873. 27
  27. 27. How to Communicate the Importance of Fracture Prevention to Your Patients » Moderate risk patients have a 10-20% chance of having a fracture within the next 10 years1 » Vertebral fractures can cause severe, disabling back pain, dowager’s hump2, and increase the likelihood of death within 5 years (~4 times)3 1. Papaioannou A, et al. CMAJ. 2010;182:1864-1873. 2. Watts NB. Neurosurg Focus. 2001;10(4):E12. 3. Ioannidis G, et al. CMAJ. 2009;181:265-71 28
  28. 28. How to Communicate the Importance of Fracture Prevention to Your Patients » Women with a wrist fracture have double the risk of any future osteoporotic fracture1 » Vertebral fracture predicts future hip fracture2 » A hip fracture increases the likelihood of death by 3 fold3 and increases admissions to long term care4 » Therapy could reduce the risk of this happening5 Explain to your What is the moderate risk of fracture could mean6 patients what a Call to Action? 1. Barrett-Connor E et al. Osteoporos Int. 2008;19:607-613. 2. Melton LJ III et al. Osteoporos Int. 1999; 10:214-221. 3. Ioannidis G, et al. CMAJ. 2009;181:265-71. 4. Osteoporosis Long-term Care. http://osteoporosislongtermcare.ca/ Accessed Feb 2012. 5. Siris ES, et al. Mayo Clin Proc. 2006;81:1013-1022. 6. Steering Group Communications. Feb 9th, 2012. 29
  29. 29. Audience Question: » When presenting treatment options to patients what is the most important thing to consider and discuss?: A. B. C. D. E. Reducing fracture risk Maintaining or increasing BMD Safety profile and side-effects Adherence to medication & patient preference All of the above 30
  30. 30. Evaluating Treatment Recommendations Goal of Osteoporosis Treatment: To reduce fractures through risk reduction, early diagnosis & appropriate treatment.1 Considerations: » Mechanism of action » Efficacy » Risk/benefit ratio – safety & tolerability » Generic vs. branded medication » Patient preference and adherence » Drug cost and coverage 1. Osteoporosis Canada 2008 National Report Card 31
  31. 31. Mechanism of Action of Available Osteoporosis Therapies Osteoclast Precursors Estrogen therapy Selective estrogen receptor modulators Hormones RANKL RANK Multinucleated Osteoclast Bisphosphonates Binds to bone; inhibits osteoclasts Teriparatide Denosumab PTH analog RANK Ligand inhibitor Osteoblast Adapted from: Boyle WJ et al. Nature 2003; 423:337-342. Osteoclast 32
  32. 32. Anti-fracture Efficacy of Current Therapies Therapeutic Options for Fracture Prevention in PMO Women1*† Bone Formation Therapy Antiresorptive Therapy Type of Fracture Bisphosphonates Alendronate Risedronate Zoledronic Acid Denosumab Raloxifene Estrogen * (Hormone Therapy) Vertebral        Hip     -  - Nonvertebral†     -   Teriparatide * Based on GRADE A evidence as assessed in the Osteoporosis Canada 2010 Clinical Practice Guidelines for the Diagnosis and Management of Osteoporosis in Canada † For postmenopausal women, indicates first line therapies and Grade A recommendation. ‡ Hormone therapy (estrogen) can be used as first-line therapy in women with menopausal symptoms. ∆ In Clinical trials, non-vertebral fractures are a composite endpoint including hip, femur, pelvis, tibia, humerus, radius, and clavicle. 1. Papaioannou A, et al. CMAJ. 2010;182:1864-1873. 33
  33. 33. BMD Efficacy of Long-term Treatment* In long term trials, BMD continues to increase or remains stable Pivotal Study Extended Treatment Duration (yrs) # of Participants % Change Lumbar Spine BMD Ŧ % Change Total Hip BMDŦ Risedronate1 VERT-MN 7 68 11.5 3.9 Alendronate¥2 FLEX 10 86 13.7 6.7 Zoledronic Acid3 HORIZON (interim analysis of 9 year study) 6 616 12.1 4.3 Denosumab4 FREEDOM (interim analysis of 10 year study) 6 2343 15.2 7.5 Medication * Not head to head analyses: Results cannot be compared due to differing study populations and methodologies. Ŧ Represents % change from BL of Pivotal Trial. ¥Represents 10 mg dose only. 1. Mellstrom D et al. Calcif Tissue Int 2004;75:462–468 2. Bone HG et al. N Engl J Med 2004;350:1189-99. 3. Black DM, et al. J Bone Miner Res. 2012; 27(2):243-254. 4. Brown JP, et al. 2011 ACR Annual Meeting. Presentation L8 34
  34. 34. What is the safety of long-term treatment? Placebo (Years 13) (n = 3861) Zoledronic Acid (Years 1-3) (n = 3875) Zoledronic Acid (Years 3-6) (n =613) Serious AEs 30.1% 29.2% 31.2% Increase in serum creatine >0.5 mg/dL 0.4% 1.2%* 2.9%* Atrial Fibrillation (Serious AE) 0.5% 1.3%* 2.0% Zoledronic Acid (HORIZON ext)2,3 – 6 years Risedronate (VERT MN ext)1 – 5 years RIS (n = 135) Placebo (n = 130) Any serious AE 24.4% 30.0% Alendronate (FLEX ext)4,5 – Years 8-10 Incidence of AEs, % Denosumab (FREEDOM Ext)6 Exposure-adjusted subject incidences of AEs (Rates per 100 subject-years) Discontinuatio n (n=83) 21.7 20.9 Placebo ALN (10 mg) (n=86) Serious Aes Denosumab Years 1-3 (n = 3883) Serious AEs Infections** Years 1-3 (n = 3879) Years 4-6 (n = 2343) 10.4 10.6 10.6 1.3 1.5 1.3 • ONJ and atypical femoral fractures have been reported • **Incidence of celllulitis/erysipelas similar in extension to that seen in placebo group of pivotal trial * p<0.05 compared to placebo 1. Sorensen OH, et al. Bone 2003;32:120-126. 2. Black D, et al. N Eng J Med. 2007; 356 : 1809-1822. 3. Black DM, et al. J Bone Miner Res. 2012; 27(2):243-254. 4. Black DM JAMA. 2006; 296: 2927-38. 5. Bone HG et al. N Engl J Med 2004;350:1189-99. 6. Papapoulos S et al. J Bone Miner Res. 2012;27:694-701. 35
  35. 35. Safety and Tolerability of Available Treatments Bisphosphonates Denosumab Raloxifene Teriparatide Hypocalcemia* Hypocalcemia* Vasodilation Transient orthostatic hypotension GI symptoms† Infections (serious events 4.1% vs. 3.4% placebo) Venous thromboembolism (↑ risk vs. placebo) Osteosarcoma (only observed in animal trials, not clinical trials) Postmarketing reports of musculoskeletal pain Dermal events (10.8% vs. 8.2% placebo) Lipid and triglyceride monitoring Urolithiasis § Osteonecrosis of jaw‡ Osteonecrosis of jaw‡ Stroke¶ Atypical Fracture (rare) Atypical Fracture (rare) Renal impairment ** Suppression of bone turnover Atrial fibrillation (2.5% vs. 1.9% placebo) * Correct with adequate calcium & Vitamin D intake prior to initiating therapy. † Rarely, oral bisphosphonates have been associated with severe esophageal events. ‡ Uncommon; mostly with cancer patients and/or dental procedures. ¶ Consider risk/benefit balance for women with a history of stroke or risk factors for stroke or venous 36 thromoboembolism.§Urinary calcium monitoring should be considered for patients with active urolithiasis and hypercalciuria. ** Recommended that all patients have their renal function assessed prior to treatment. Refer to respective Product Monographs for full Prescribing Information.
  36. 36. Preference and Adherence » Decision to treat should be based on patient benefit/risk profile » However, also consider: – – – – patient preference commitment to therapy fit of therapy with lifestyle other medical considerations 1. Papaioannou A, et al. CMAJ. 2010;182:1864-1873. 37
  37. 37. Challenges in Managing Patients on Treatment 38
  38. 38. Learning Objective  Overcome challenges in PMO management. 39
  39. 39. Audience Question: » If your currently treated patient is not responding to treatment (decrease in BMD) on an oral bisphosphonate, what would you recommend? A. Offer her a different oral bisphosphonate (alendronate/risedronate) B. Offer her a medication with a different mechanism of action (i.e. denosumab, raloxifene) C. Offer her a medication with a different route of administration (i.e. denosumab, zoledronic acid) D. Keep her on her current therapy and continue to monitor her E. Let her stop therapy 40
  40. 40. Ensure that a Loss in BMD is not due to Secondary Causes of Osteoporosis What are the recommended Biochemical Tests? » Calcium, corrected for albumin » Complete blood count » Serum creatinine (eGFR) » Alkaline phosphatase » Thyroid stimulating hormone (TSH) » Serum protein electrophoresis for patients with vertebral fractures » 25-hydroxy vitamin D (25-OH-D)* * Should be measured after 3-4 months of adequate supplementation and should not be repeated if an optimal level ≥75 nmol/L is achieved. 1. Papaioannou A, et al. CMAJ. 2010;182:1864-1873. 41
  41. 41. Is your patient failing on treatment? Treatment failure can be considered after 1 year on therapy if1: - Patient has a decrease in BMD on treatment (4-5%) - Patient has 2 or more fragility fractures on treatment » Are there any new risk multipliers in your patient’s profile that would increase bone loss? – Change in medications – Co-morbidities » Consider that lack of adherence could also cause treatment failure 1. Diez-Perez A et al. Osteoporos Int 2012 23:2769-2774 42
  42. 42. Is your patient taking their oral BP properly? Instructions for taking oral BPs:       In the morning, at least 1/2 hour before breakfast Should remain sitting upright for at least 1 hour Take only with water* Take alone, with no other medications Give only to residents who can swallow effectively Vitamin D and calcium supplements should be taken at a different time *Risedronate DR – needs to be taken with food www.osteoporosislongtermcare.ca 43
  43. 43. Consider Drug Tolerance » Generic agents may not be as well tolerated as the branded version1 » Risedronate DR – may ease administration burden, however, in clinical trial the GI events were similar to those seen with Actonel weekly2 – Calcium supplements must be given separately 3 » GI intolerant patients who are taking a PPI may have decreased efficacy of the BP and fracture risk4 1. Papaioannou A, et al. J Clin Densitometry 2008;11:458-459. Abstract 152. 2. McClung MR et al. Osteoporos Int as DOI 10.1007/s00198-0111791-y 3. Actonel Product Monograph, Warner-Chilcoott. 4.Targownik LE, Lix LM, Metge CJ, et al. Use of proton pump inhibitors and risk of osteoporosis-related fractures. CMAJ 2008;179:319-26. 44
  44. 44. Is your patient afraid to take their medication? Help put patient concerns in perspective Fatal motor vehicle accidents 8.4/100,000 person/year1 Murder ONJ* 1.8/100,000 person/year2 <1/100,000 pts/year3 Atypical fracture** 2/100,000 pts on 2 yrs BPs 113.3/100,000 pts on 8 yrs BPs4 For every 100 hip fractures prevented there is 1 atypical femur fracture5 *The risk of ONJ is higher among cancer patients treated with high doses anti-resorptives6 **Reports of AFF have also been documented with other osteoporosis therapies7-8 and in patients who have never received BP therapy9 1. Transportation Canada. 2007 Casualty Rates. http://www.tc.gc.ca/eng/roadsafety/tp-tp3322-2007-1039.htm#t5. 2. Statistics Canada. 2009 Homicide Rate. http://www40.statcan.ca/l01/cst01/Legal12b-eng.htm. 3. Khan A, et al.J Rheumatol. 2011;38:1396-1402. 4. Dell R, et al. JBMR 2011. 27(12): 2544-2550. 5. Wang et al JBMR 2011; 26: 553- 45
  45. 45. Polypharmacy: An Adherence Issue in Osteoporosis Patients » Patients on osteoporosis medication have a high likelihood of being on multiple medications for other chronic diseases – 40% of women on bisphosphonate therapy are also on ≥4 other concomitant medications1 » Polypharmacy can decrease adherence rates – Women on several other medications were 21% more likely to discontinue weekly BPs2 BP = bisphosphonate 1. Gold DT, et al. Gend Med. 2008;5:374-84. 2. Lo JC, et al. Osteoporos Int. 2006;17:922-928. 46
  46. 46. Would Switching Therapy Benefit Your Patient? After switching from alendronate, denosumab increases BMD1 and zoledronic acid maintains2 BMD at lumbar spine Percent Change in Lumbar Spine BMD (%) Zoledronic acid 5 mg QY (n = 113) Alendronate 70 mg QW (n = 241) Alendronate 70 mg QW (n = 112) 3.03% 3 † 2 1.85% 1 P<0.0001 0 0 6 Study Month 12 Percentage Change In Lumbar Spine BMD (%,) Denosumab 60 mg Q6M (n = 246) 4 4 3 2 1 0.81% NS 0.17% 0 0 12 Study Month n = number of patients. NS = not statistically significant » No increase in adverse events upon switching therapies1,2 Adapted from: 1. Kendler DL, et al. J Bone Miner Res. 2010;25:72-81. 2. McClung M, et al. Bone. 2007;41:122-128. 47
  47. 47. Would Switching Therapy Benefit Your Patient? Greater increases in BMD at 12 months in patients who transitioned to denosumab vs. patients who transitioned to risedronate1 Patients were previously on alendronate but had stopped taking alendronate or had insufficient adherence. BMD data results are not meant to imply fracture efficacy and should not be extrapolated to predict differences in fracture efficacy. Head-to-head fracture studies have not been conducted. *Data are least-squares means and 95% confidence intervals. †p < 0.0001 denosumab vs risedronate. 1. Adapted from: Roux C, et al. Presented at: The American Society for Bone and Mineral Research Annual Scientific Meeting; October 12-15, 2012; Minneapolis, MN. 48
  48. 48. When Selecting a Therapy Consider That Adherence is Different Between Treatments 2 year, open-label, cross-over study of 250 postmenopausal women • 92% Adherence to Denosumab after 12 month Alendronate Percent of Subjects Adherent after 2 years 100 80 Denosumab (N = 106) 92.5% 60 Alendronate (N = 115) 63.5% 40 20 0 Adherence Freemantle N, et al. Osteoporos Int. 2012; 23: 317-326 49
  49. 49. Patient Support Programs can Improve Adherence Consider patient support programs offering services such as nurse support, reimbursement information, dose reminders, and education1,2 Adherence in these programs has been shown to be as high as 94%3 Reputable websites on osteoporosis and therapies may also provide patients with valuable information • Osteoporosis Canada4: • Patient and physician resources • Links to scientific references • HealthandBone.ca5: • Educational website for patients • Drugcoverage.ca6: • Search tool • Overview of private insurance plans and government drug benefit programs 1. For My Bones Program. Available at: https://www.formybones.ca/help_en.do. Accessed October 2010 report 2. Patient Direct, ProVital ™ Program. Available at: http://www.provital.ca. Accessed Nov 30, 2011. 3. Patient Direct, ProVital ™ Program, as at Nov 30, 2011 report. 4. Osteoporosis Canada. Available at: http://www.osteoporosis.ca. Accessed November 2010. 5. Health and Bone. 50 Available at: http://www.healthandbone.ca/en/home. Accessed November 2010. 6. Drug Coverage.ca Available at: http://www.drugcoverage.ca Accessed October 2010.
  50. 50. How do I Approach Drug Holiday in Osteoporosis Management? Drug holiday: time off of bisphosphonate therapy, assuming reinitiation in future. 1 RECOMMENDATIONS: Patients at HIGH RISK for fracture should continue therapy2 After 3-5 years of therapy, re-assess your patient1,3-4: BMD ≤ -2.5 or fracture or ongoing glucocorticoid therapy Evaluate Continued Therapy BMD >-2.5 and no fracture Consider A Drug Holiday 1. Watts NB & Diab DL. J Clin Endocrinol Met; 2010, 95 (4): 1555-1565 2. Papaioannou A, et al. CMAJ. 2010;182:1864-1873. 3. Black DM et al. NEJM 2012;366:2051-2053. 4. Cummings SR et al. JBMR 2013 DOI 10.1002/jbmr.1854. 51
  51. 51. Clinical Pearls 52
  52. 52. Clinical Pearls for Patient Assessment: 1.Have they fallen? 2.Has their BMD decreased (>3%) since their last BMD? 3.Have they lost height? (> 2cm height since last visit or >6 cm historically) 4.Have they broken any bones? 5.Are there any other risk factor multipliers to consider? –If yes: they are at increased fracture risk and should be further assessed, possibly by a lateral x-ray 53
  53. 53. Clinical Pearls for Who to Treat » Treat all patients at HIGH RISK for fracture: –Prior hip or vertebral fracture –Multiple fractures –10 yr absolute fracture risk » Patient at MODERATE RISK for fracture: – Consider additional risk factors – Discuss fracture risk and treatment options with patient 54
  54. 54. Clinical Pearls for Patient Management 1.Have they broken any bones since their last visit? 2.Has their BMD decreased > 3% since their last BMD? 3.Are they not taking their medication properly? 4.Is their BMD stable? 5.Are there new risk factors since their last visit? –If yes – they may still be at increased risk for fracture –Add other multipliers 55
  55. 55. Clinical Pearls for Patient Management 1. Individuals at HIGH RISK for fracture should continue osteoporosis therapy1 2. When monitoring patients on therapy, consider: • Efficacy • Tolerability/Side Effects • Adherence • Preference 1. Papaioannou A, et al. CMAJ. 2010;182:1864-1873. 56
  56. 56. Final Clinical Pearl • The goal of PMO treatment and management is preventing a fracture. Healthy bones are strong bones! 57
  57. 57. Question and Answer Session 58

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