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Critical Challenges in Osteoporosis Prevention and Treatment Completing the Journey From Trial- and Expert-Based Information to Clinical Application in.

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Presentation on theme: "Critical Challenges in Osteoporosis Prevention and Treatment Completing the Journey From Trial- and Expert-Based Information to Clinical Application in."— Presentation transcript:

1 Critical Challenges in Osteoporosis Prevention and Treatment Completing the Journey From Trial- and Expert-Based Information to Clinical Application in The Primary Care Setting Screen & Intervene Critical Challenges in Osteoporosis and Womens Health

2 Critical Challenges in Osteoporosis Prevention and Treatment Osteoporosis-An Undertreated Condition Osteoporosis-An Undertreated Condition Complications of Osteoporotic Fractures Complications of Osteoporotic Fractures Indications for Screening Indications for Screening Interpretation of BMD Measurements Interpretation of BMD Measurements Aggregate Analysis of Risk Factors Aggregate Analysis of Risk Factors What Have We Learned Thus FarA Summary

3 Treatment Indications and Triggers Treatment Indications and Triggers Pharmacological Therapy for Fracture Prevention Pharmacological Therapy for Fracture Prevention Relationship between BMD changes and Vertebral/Nonvertebral Fractures Relationship between BMD changes and Vertebral/Nonvertebral Fractures Vertebral and Nonvertebral Fracture Prevention Vertebral and Nonvertebral Fracture Prevention We will now discuss Adherence/Compliance, and Their Relationship to Outcomes We will now discuss Adherence/Compliance, and Their Relationship to Outcomes What Have We Learned Thus FarA Summary Critical Challenges in Osteoporosis Prevention and Treatment

4 Definitions Initiation- Getting the prescription filled. About 10% of prescriptions are never filled. Initiation- Getting the prescription filled. About 10% of prescriptions are never filled. Adherence- Taking the medicine. Often defined as taking more than 80% of pills over a specified period of time. Adherence- Taking the medicine. Often defined as taking more than 80% of pills over a specified period of time. Compliance- Taking the pills correctly. Important issue with bisphosphonates. Compliance- Taking the pills correctly. Important issue with bisphosphonates. Persistence- Still taking the pills. Often measured at the one year time point. Persistence- Still taking the pills. Often measured at the one year time point.

5 Non-Adherence How Large is The Problem? Studies of patient behavior show that LESS THAN 50% of the people who leave a doctor's office with a prescription adhere and comply with drug therapy

6 Simons, et al MJA 1996; 164:208. n = 610 Persistence with Lipid-Lowering Therapy

7 The Effects of Non-Adherence 1) Poor patient outcomes due to sub-optimal therapeutic response sub-optimal therapeutic response 2) Increased cost burden to society Osterberg L,Blaschke T, N Engl J Med 2005;353:487-97

8 Poor Patient Outcomes Increased Morbidity due to disease exacerbations Increased Morbidity due to disease exacerbations More treatment Failures with potential for addition or switching of medications due to perceived inefficacy More treatment Failures with potential for addition or switching of medications due to perceived inefficacy More frequent Physician Visits More frequent Physician Visits Increased Hospitalizations Increased Hospitalizations Excess Mortality Excess Mortality Osterberg L,Blaschke T, N Engl J Med 2005;353:487-97

9 Costs To Society 10% excess in all hospital admissions 10% excess in all hospital admissions 125,000 to 200,000 deaths per year 125,000 to 200,000 deaths per year Billion dollars excess cost per year in the U.S Billion dollars excess cost per year in the U.S. Osterberg L,Blaschke T, N Engl J Med 2005;353:487-97

10 What Are the Possible Causes of Poor Adherence? Disruption to daily routine? (need for frequent dosing) Concern about side effects? Target disease" eclipsed by other chronic conditions? Lack of positive reinforcement? Complex dosing guidelines? Poor patient education (Health Illiteracy) POOR ADHERENCE

11 Health Literacy *(Selden et al. 2000; Healthy People 2010, HHS 2000; Ratzan & Parker 2000) **(Institute of Medicine report- 2004) The degree to which individuals have the capacity to obtain, process, and understand basic information and make appropriate decisions about their health* 90 million people in the United States, nearly half of all adults, have difficulty understanding and using health information**

12 Literacy Level Predicts Health Outcomes Less knowledge of disease and self-care Less knowledge of disease and self-care Worse self-management skills Worse self-management skills Lower use of screening Lower use of screening Lower medication compliance rates Lower medication compliance rates Higher rates of hospitalization and morbidity Higher rates of hospitalization and morbidity Literacy level is more important than racial or ethnic group, age, employment, income or education in predicting poor outcome Literacy level is more important than racial or ethnic group, age, employment, income or education in predicting poor outcome

13 Patient Beliefs Affect Compliance Dont believe diagnosis or the seriousness of the diagnosis Dont believe diagnosis or the seriousness of the diagnosis Believe other diseases are more important Believe other diseases are more important Believe side effects outweigh benefits Believe side effects outweigh benefits Concerned about their ability to carry out recommended action Concerned about their ability to carry out recommended action AARP Survey, 1985 National Prescription Buyers Survey, USA 1985

14 Lack of Communication Study of 300 medical encounters: doctors spent average 1.3 minutes giving information 1 Study of 300 medical encounters: doctors spent average 1.3 minutes giving information 1 Study of 264 visits to family physicians.- during patient initial statement of the problem, physician interrupted after average of 23 seconds. 2 Study of 264 visits to family physicians.- during patient initial statement of the problem, physician interrupted after average of 23 seconds. 2 50% of patients leave office visit not understanding what the doctor said 3 50% of patients leave office visit not understanding what the doctor said 3 Clement, Diab Care 1995;18:1204. Waitzkin. JAMA 1984;252: Kravitz et al. Arch Intern Med 1993;153: Roter and Hall. Ann Rev Public Health 1989;10:163. Marvel JAMA 1999;281:283. 3

15 Physicians Contribute to Patients Poor Adherence By: Prescribing complex regimens Prescribing complex regimens Failing to explain the benefits and side effects of a medication adequately Failing to explain the benefits and side effects of a medication adequately Not giving consideration to the patients lifestyle or the cost of the medications Not giving consideration to the patients lifestyle or the cost of the medications Osterberg L,Blaschke T, N Engl J Med 2005;353:487-97

16 Nonadherence to Osteoporosis Medications: How Common Is It?

17 Adherence With Osteoporosis Medications Is Sub-optimal Tosteson ANA, et al. Am J Med. 2003;115: % to 25% of Patients Abandon Therapy Within 7 Months Patients Abandoning Treatment (%) Hormone Replacement Therapy (n=334) Bisphosphonate (n=366) Selective Estrogen Receptor Modulator (n=256) Telephone survey of 956 randomly selected women with postmenopausal osteopenia or osteoporosis who initiated therapy in Mean follow-up was 7 months. 26% 19%

18 Ettinger M, et al. Arthritis Rheum. 2004;50(suppl):S513-S514. Abstract A HIPAA-compliant, longitudinal patient database of prescriptions dispensed from ~25% of US retail pharmacies was used to assess discontinuation of bisphosphonates over a 12-month period in women aged 50 years.* *Primary usage in osteoporosis; however, data may include use in other indications. Adherence With Oral Bisphosphonates Is Suboptimal, Regardless of Dosing Percentage of Patients on Therapy (defined as having at least 1 day of medication supply in the month) P<0.001 vs daily therapy Oct 2002 NovDecJanFebMarAprMayJunJulAugSepOct 2003 Patients on Therapy (%) Daily Bisphosphonates (n=33,767) Weekly Bisphosphonates (n=177,552) 54.6% 36.9%

19 Surgeon Generals Report Cites Need to Improve Adherence With Osteoporosis Therapies Long-term adherence rates with any medication are poor (~50%) Long-term adherence rates with any medication are poor (~50%) Follow-up strategies that improve adherence to should be applied to osteoporosis Follow-up strategies that improve adherence to should be applied to osteoporosis –Simplifying the treatment regimen –Counseling –Addressing patient concerns about side effects –Maintaining an encouraging provider-patient relationship US Department of Health and Human Services. Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville, MD: US Department of Health and Human Services, Office of the Surgeon General; 2004.

20 Potential Consequences of Poor Adherence to Osteoporosis Therapy Poorer clinical outcomes Poorer clinical outcomes –Less effective suppression in the rate of bone turnover 1 –Lower gains or greater losses in bone mineral density 1,2 –Greater risk of fractures 3 Higher medical costs 4 Higher medical costs 4 1.Eastell R, et al. Calcif Tissue Int. 2003;72:408. Abstract P Finigan J, et al. Osteoporos Int. 2001;12:S48-S49. Abstract P Caro JJ, et al. Osteoporos Int. 2004;15: McCombs JS, et al. Maturitas. 2004;48:

21 Non-Adherence to Osteoporosis Medication Affects BMD Yood R, et al Osteoporosis int 14: Lumbar BMD

22 Non-Adherence to Osteoporosis Medication Increases Fracture Risk 11,249 women suffering from osteoporosis with a mean age of 68.4 years and average follow-up of 2 years 16% decrease Caro JJ et al. Osteoporosis Int 14, 2003, Suppl 7 Fracture Rate %

23 *P< Compliant is defined as taking medication 80% of the time over a 24-month period. Retrospective cohort study that used longitudinal medical and pharmacy claims data from Medstat MarketScan ® Research Databases to assess adherence and fracture risk over 24 months ( ). Siris E, et al. Presented at: Sixth International Symposium on Osteoporosis. April 6-10, 2005; Washington, DC. Better Long-term Compliance Reduces the Risk of Fracture Compliance With Bisphosphonates and Fracture Risk Over 2 Years in Women 45 Years With Postmenopausal Osteoporosis (n=6825) % Patients With Fracture (n=3400)(n=3425) * 9.4% 12.6%

24 How Can Adherence Be Improved?

25 Improving Adherence by Reinforcing Treatment Efficacy Patient monitoring may be helpful in demonstrating effects of treatment 1-3 Patient monitoring may be helpful in demonstrating effects of treatment 1-3 –BMD –Biochemical markers of bone turnover Frequent visits or calls from staff Frequent visits or calls from staff Clowes et al. JCEM. 2004;89: ) Deal CL. Curr Rheumatol Rep. 2001;3: Chapurlat RD, Cummings SR. Osteoporos Int. 2002;13:

26 Improving Adherence Through Modifying Dosing Interval: Focus on Bisphosphonates Survey data suggests that patients prefer more widely-spaced dosing intervals Survey data suggests that patients prefer more widely-spaced dosing intervals Retrospective data suggest improved adherence with once-weekly versus daily bisphosphonates Retrospective data suggest improved adherence with once-weekly versus daily bisphosphonates To date, there are no prospective data demonstrating that extended dosing regimens improve patient adherence and clinical outcomes To date, there are no prospective data demonstrating that extended dosing regimens improve patient adherence and clinical outcomes

27 Women Preferred Weekly over Daily 288 postmenopausal women with osteoporosis 288 postmenopausal women with osteoporosis –4 weeks of alendronate Weekly followed by 4 weeks alendronate Daily –4 weeks of alendronate Daily followed by 4 weeks alendronate Weekly At the final visit, patients completed a preference study questionnaire: Which Treatment Routine… At the final visit, patients completed a preference study questionnaire: Which Treatment Routine… Alendronate Simon JA et al Clin Ther 2002;24: Do You Prefer? Patients (%) Is More Convenient? Would Be Easier to Comply With For a Long Period of Time?

28 33% Once a month Once a week Women Preferred Monthly over Weekly Dosing Schedule Preference (n = 367)* p <0.001 *Among women expressing a preference, 67% prefer once-a-month dosing, a statistically significantly higher proportion than the 33% who prefer once-a-week dosing Patients Say They Prefer a Once-a-month Over a Once-a-week Dosing Schedule 67% Simon JA et al Female Patient 2005;30:31-6

29 BALTO- Study Design A randomized, prospective, 6 month Phase IIIB, open-label, multi-center, crossover study A randomized, prospective, 6 month Phase IIIB, open-label, multi-center, crossover study Primary Endpoint – Proportion (%) of patients preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate Primary Endpoint – Proportion (%) of patients preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate Secondary Endpoint – Proportion (%) of patients perceiving the once-monthly dosing of ibandronate to be more convenient versus once-weekly dosing of alendronate Secondary Endpoint – Proportion (%) of patients perceiving the once-monthly dosing of ibandronate to be more convenient versus once-weekly dosing of alendronate Emkey R et al Curr Med Res Opin Dec;21(12):

30 * p < vs alendronate Excludes those patients who did not express a preference for one treatment / m ITT population Twenty-two patients did not express preference Patient Preference: Ibandronate Monthly vs Alendronate Weekly Preferred Treatment Patients (%) n = 197n = 79 Emkey R et al Curr Med Res Opin Dec;21(12): (Patients Expressing Preference)

31 * p < vs alendronate Excludes those patients who did not express a preference for treatment Thirty-two patients found both treatments equally convenient More Convenient Therapy Patients (%) n = 197n = 67 Patient Preference: Ibandronate Monthly vs Alendronate Weekly (Those Expressing Convenience) Emkey R et al Curr Med Res Opin Dec;21(12):

32 Principles of Evidence-Based Medicine Acquire the Evidence Acquire the Evidence Critically Appraise the Evidence Critically Appraise the Evidence Apply the Evidence to the Individual Patient Apply the Evidence to the Individual Patient

33 Evidence-Based Medicine: Integrate Findings With Clinical Expertise and Patient Needs Clinical Expertise Research Evidence Patient Preferences Rx Adapted from: Sackett DL et al. Evidence-Based Medicine: How to Practice and Teach EBM. 2nd ed. Churchill Livingstone; 2000

34 Summary Adherence to daily and weekly bisphosphonates is suboptimal Adherence to daily and weekly bisphosphonates is suboptimal Poor adherence may compromise clinical outcomes and may increase healthcare utilization Poor adherence may compromise clinical outcomes and may increase healthcare utilization Need to improve communication and education of patients utilizing all available resources Need to improve communication and education of patients utilizing all available resources Among other factors, dosing frequency may be an important determinant of adherence with bisphosphonates Among other factors, dosing frequency may be an important determinant of adherence with bisphosphonates

35 Drugs dont work in people that dont take them C. Everett Koop, M.D.

36 Applying Evidence to Practice Prevention and Treatment of Patients Suspected or Confirmed Osteoporosis: An Interactive Case Study Approach Case Study # 1: Low BMD in An Early Postmenopausal Woman

37 Case 1 LR is a 52 year old newly menopausal white woman LR is a 52 year old newly menopausal white woman –She has hot flashes but no fractures or height loss –She is of average height and weight (52, 137 pounds) –She has an intact uterus –There is no family history of OP –She had never undergone BMD testing However, you ordered a DXA which showed a T-score of -1.8 in lumbar spine and -1.5 in femoral neck

38 Diagnosed as osteopenia Diagnosed as osteopenia What would you do? What would you do? Would you treat with an antiresorptive therapy? Would you treat with an antiresorptive therapy? Case 1

39 With no history of fx or FH, her absolute risk for an osteoporotic spine, hip or wrist fx over the next 5 years is very low at <0.12%/y With no history of fx or FH, her absolute risk for an osteoporotic spine, hip or wrist fx over the next 5 years is very low at <0.12%/y No utility for bone markers in this age group No utility for bone markers in this age group No treatments have been proven to reduce fx risk in women in their 50s with osteopenia, although several treatments may reduce bone loss No treatments have been proven to reduce fx risk in women in their 50s with osteopenia, although several treatments may reduce bone loss Bisphosphonates or PTH although effective would probably be unjustified based on her low absolute risk and the high NNT of 2000 Bisphosphonates or PTH although effective would probably be unjustified based on her low absolute risk and the high NNT of 2000 Case 1

40 Consider preventive approaches Consider preventive approaches At her age with a uterus she is more likely to have an AE from HRT (VTE, MI, breast CA) than a beneficial outcome At her age with a uterus she is more likely to have an AE from HRT (VTE, MI, breast CA) than a beneficial outcome Raloxifene is an option Raloxifene is an option –May lower risk of breast ca –May aggravate hot flashes Calcium and vitamin D Calcium and vitamin D Case 1

41 Case 1: What Mrs. LR Chose To Do… Chose to decline any pharmacologic intervention Chose to decline any pharmacologic intervention Agreed to calcium supplementation 500mg bid, a MVI, and an exercise program Agreed to calcium supplementation 500mg bid, a MVI, and an exercise program Began to experiment with soy preparations Began to experiment with soy preparations –No evidence that these agents reduce fx risk or prevent bone loss

42 Case 2. A postmenopausal woman who recently discontinued HRT but has low BMD

43 RG is a 68-year-old woman who has been on HT since menopause RG is a 68-year-old woman who has been on HT since menopause –She initially took HT for hot flashes but continued when she was told of benefits for her heart and bones –When she heard the WHI results she discontinued HT She has scheduled a visit with you to discuss whether she needs additional therapy to treat or prevent OP She has scheduled a visit with you to discuss whether she needs additional therapy to treat or prevent OP Case 2

44 Case 2: History Mrs. RG Meds: no calcium or vitamin D supplements Meds: no calcium or vitamin D supplements –She takes a MVI –She is lactose intolerant –She has lost 2 inches in height Approximately 10 years ago she broke her forearm when she slipped on the sidewalk Approximately 10 years ago she broke her forearm when she slipped on the sidewalk No FH of OP No FH of OP

45 At age 65 she had a DXA which showed spine T-score of -2.0 and total hip T-score of -2.2 At age 65 she had a DXA which showed spine T-score of -2.0 and total hip T-score of -2.2 She has OP based on relatively low BMD and history of fracture She has OP based on relatively low BMD and history of fracture Her absolute risk of fracture in 5 years will be high, assuming that HRT effects on bone will diminish with time Her absolute risk of fracture in 5 years will be high, assuming that HRT effects on bone will diminish with time Case 2: History Mrs. RG

46 Need to exclude secondary OP Need to exclude secondary OP –Serum calcium –TSH –25 OH D –24 hour urinary calcium Case 2

47 Case 2: Medical Recommendations Mrs. RG Calcium supplementation 1200 mg Calcium supplementation 1200 mg 800 IU vitamin D (her MVI has 400 IU) 800 IU vitamin D (her MVI has 400 IU) Exercise Exercise Medication options: Medication options: –Bisphosphonates weekly or monthly –SERMS Follow-up BMD in two years Follow-up BMD in two years

48 Case 2: What Mrs. RG Did Ibandronate 150 mg once monthly Ibandronate 150 mg once monthly 1000 mg calcium supplementation 1000 mg calcium supplementation 400 IU vitamin D plus her MVI 400 IU vitamin D plus her MVI

49 Case 3. Severe postmenopausal osteoporosis

50 Case 3: Mrs. RW 70 year old woman with low BMD and multiple vertebral fractures who has been on a weekly bisphosphonate, ca, vitamin D for two years 70 year old woman with low BMD and multiple vertebral fractures who has been on a weekly bisphosphonate, ca, vitamin D for two years –Her lumbar spine T-score in Jan 2001 was -3.0 –A repeat DXA today shows a lumbar spine T-score of -3.5, and a FN T-score of -3.0 –She has significant midback pain and has new OP fx of the thoracic spine with significant deformity Vertebroplasty was recommended by her PCP Vertebroplasty was recommended by her PCP

51 Case 3: MRI Series T1T2T2 STIR

52 Case 3: The Magnitude of the Loss is Troublesome Consider the following: Is she a non-responder? Is she a non-responder? Is she taking her bisphosphonate? Is she taking her bisphosphonate? Is the bisphosphonate being absorbed? Is the bisphosphonate being absorbed? Are there secondary causes of osteoporosis contributing to her bone loss and fractures? Are there secondary causes of osteoporosis contributing to her bone loss and fractures? What therapeutic interventions both pharmacologic and nonpharmacologic should we consider? What therapeutic interventions both pharmacologic and nonpharmacologic should we consider?

53 Case 3: What Mrs. RW Did Treated aggressively with opioids Treated aggressively with opioids Refused vertebral body augmentation Refused vertebral body augmentation Initially switched to another oral bisphosphonate but untx was high at 55 Initially switched to another oral bisphosphonate but untx was high at OHD level OHD level 35 Calcium supplementation to 1500 mg/daily Calcium supplementation to 1500 mg/daily Switched to Forteo Switched to Forteo Back pain diminished Back pain diminished 6% increase in lumbar spine BMD at 6 months 6% increase in lumbar spine BMD at 6 months

54 Case 4. Age related osteoporosis

55 Case 4: Mrs. PR An 80-year-old frail, community dwelling woman who lives alone An 80-year-old frail, community dwelling woman who lives alone –She has no hx of fx but falls often during the year –She takes 1000 mg calcium daily and a MVI –She does not go out in the sun –She has difficulty walking –She has a long hx of GERD –She has HBP treated with beta blockers –BMD T-score of -2.8 at hip and -2.0 in spine

56 Case 4: Medical Recommendations Mrs. PR Falls assessment Falls assessment Check vitamin D Check vitamin D –She had 25 OHD level of 8 ng/ml –50,000 U of oral vitamin D weekly for 3 months Take calcium in divided doses Take calcium in divided doses Exercise program Exercise program Hip protectors Hip protectors Her risk of NVF is high 10%/year Her risk of NVF is high 10%/year Started on a bisphosphonate Started on a bisphosphonate

57 Case 4: What Mrs. PR Did 50,000 U ergocalciferol weekly for 3 months 50,000 U ergocalciferol weekly for 3 months Chose weekly bisphosphonate Chose weekly bisphosphonate PT program PT program She refused hip protectors She refused hip protectors

58 Clinical Risk Factors Femoral neck T-score + Age Age Previous low trauma fracture Previous low trauma fracture Current cigarette smoking Current cigarette smoking Rheumatoid arthritis Rheumatoid arthritis High alcohol intake (> 2 units/day) High alcohol intake (> 2 units/day) Parental history of hip fracture Parental history of hip fracture Prior or current glucocorticoid use Prior or current glucocorticoid use Adapted from Kanis JA et al. Osteoporos Int. 2005;16:

59 Intervention Threshold A fracture probability above which it is cost-effective to treat with pharmacological agents A fracture probability above which it is cost-effective to treat with pharmacological agents Based on statistical modeling using many medical, social, and economic assumptions Based on statistical modeling using many medical, social, and economic assumptions

60 Case 5

61 Patient Case #5 70 year old post menopausal female 70 year old post menopausal female Wrist fracture at age 62 Wrist fracture at age 62 T-score lumbar spine = -0.8 T-score lumbar spine = -0.8 T-score femoral neck and total hip = -1.5 T-score femoral neck and total hip = -1.5 Should she receive pharmacological therapy? Should she receive pharmacological therapy? What would you choose and why? What would you choose and why? Would you choose a different therapy if her T-score was –3.5? Would you choose a different therapy if her T-score was –3.5?

62 Case 6

63 52 year old post menopausal female 52 year old post menopausal female Mother had hip fracture at age 69 Mother had hip fracture at age 69 T-score lumbar spine = -1.5, femoral neck -1.6 T-score lumbar spine = -1.5, femoral neck -1.6 Should she receive pharmacological therapy? Should she receive pharmacological therapy? Would bone markers help your decision? Would bone markers help your decision? Patient Case #6

64 What therapy would you choose? What therapy would you choose? –Hormone therapy –SERM –Bisphosphonate- which one? She refuses pharmacological therapy: she would like to try calcium and vitamin D alone She refuses pharmacological therapy: she would like to try calcium and vitamin D alone How and how often would you monitor her? How and how often would you monitor her? Patient Case #6

65 Case 7

66 67 year old post menopausal female with osteoporosis 67 year old post menopausal female with osteoporosis On risedronate 35 mg QW for 2 years On risedronate 35 mg QW for 2 years Repeat DXA reveals 5% loss at the spine and 4.5% loss at the total hip Repeat DXA reveals 5% loss at the spine and 4.5% loss at the total hip What should you do? What should you do? Patient Case #7

67 Her DXAs were performed at the same facility: her bone loss is statistically significant according to their precision Her DXAs were performed at the same facility: her bone loss is statistically significant according to their precision She insists that she has taken her bisphosphonate every week and has followed proper administration instructions She insists that she has taken her bisphosphonate every week and has followed proper administration instructions What labs would you order? What labs would you order? Patient Case #7

68 Her serum calcium, phosphorus, alkaline phosphatase, albumin and creatinine are normal Her serum calcium, phosphorus, alkaline phosphatase, albumin and creatinine are normal 24 hour urine calcium = 175 mg 24 hour urine calcium = 175 mg 25-OH vitamin D = 35 ng/ml 25-OH vitamin D = 35 ng/ml Tissue transglutaminase- negative Tissue transglutaminase- negative Would you change her treatment? Would you change her treatment? What would you change her to? What would you change her to? Patient Case #7

69 Case 8

70 A 66 year old female has a heel ultrasound performed at a health fair A 66 year old female has a heel ultrasound performed at a health fair Her T-score at the heel = -2.5 Her T-score at the heel = -2.5 Does she have osteoporosis? Does she have osteoporosis? What other tests, if any, should be performed? What other tests, if any, should be performed? Patient Case #8

71 A DXA reveals a T-score at the spine of –2.7 and at he femoral neck of –1.9 A DXA reveals a T-score at the spine of –2.7 and at he femoral neck of –1.9 Lab workup is negative except for a 25-OH D level of 18 ng/ml Lab workup is negative except for a 25-OH D level of 18 ng/ml What therapy would you choose? What therapy would you choose? –Hormone therapy –SERM –Teriparatide –Bisphosphonate- which one? Patient Case #8

72 Case 9

73 67 year old postmenopausal female 67 year old postmenopausal female History: Heart disease, high cholesterol, hypertension and osteoporosis History: Heart disease, high cholesterol, hypertension and osteoporosis She takes alendronate 70 mg QW for OP She takes alendronate 70 mg QW for OP –Complains about taking multiple pills –Often forgets to take her medications –Requests help in simplifying her medication schedules What are some other options? Patient Case #9

74 You offer her ibandronate 150 mg once-a-month You offer her ibandronate 150 mg once-a-month How can you help her remember to take her pill every month? How can you help her remember to take her pill every month? What other methods could you use to re-inforce effectiveness of therapy and persistence? What other methods could you use to re-inforce effectiveness of therapy and persistence? Patient Case #9

75 Clinical Risk Factors Femoral neck T-score + Age Age Previous low trauma fracture Previous low trauma fracture Current cigarette smoking Current cigarette smoking Rheumatoid arthritis Rheumatoid arthritis High alcohol intake (> 2 units/day) High alcohol intake (> 2 units/day) Parental history of hip fracture Parental history of hip fracture Prior or current glucocorticoid use Prior or current glucocorticoid use Adapted from Kanis JA et al. Osteoporos Int. 2005;16:

76 Intervention Threshold A fracture probability above which it is cost-effective to treat with pharmacological agents A fracture probability above which it is cost-effective to treat with pharmacological agents Based on statistical modeling using many medical, social, and economic assumptions Based on statistical modeling using many medical, social, and economic assumptions


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