Osteoporosis: A Tale of 3 Task Forces!

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1 Osteoporosis: A Tale of 3 Task Forces! Robert A. Adler, MD McGuire Veterans Affairs Medical Center Virginia Commonwealth University Richmond, Virginia, USA

2 Disclosures The opinions are those of the speaker and not necessarily those of the Department of Veterans Affairs

3 Topics and Task Forces ASBMR Long Term Bisphosphonates for Osteoporosis AACE Postmenopausal Osteoporosis Guideline ACR Guideline for Glucocorticoid-Induced Osteoporosis

4 American College of Rheumatology - GIOP Categorizes patients by age and by fracture risk (FRAX) For patients on > 2.5 mg of prednisone equivalent daily High dose = > 30 mg/day or > 5 grams/year. For discussion, focus on adults only Very evidence based Disclosure: Membership on expert panel that helped develop the PICO (population/intervention/comparator/outcomes) questions. L Buckley, Arthritis Care Res 2017; doi /acr.23279

5 ACR-GIOP: Definition - High Risk Adults > 40 Years Old Prior osteoporotic Fracture BMD < -2.5 (spine, hip) for postmenopausal women, men > 50 years old FRAX MOF > 20% FRAX Hip > 3% Adults < 40 Years Old Prior osteoporotic fracture

6 ACR-GIOP: Definition - Moderate Risk Adults > 40 Years Old FRAX MOF 10-19% FRAX Hip > 1% < 3% Adults < 40 Years Old BMD (spine, hip) Z-score < -3 OR > 10% loss in 1 year AND > 7.5 mg Prednisone Equivalent for > 6 months

7 ACR-GIOP: Definition -Low Risk on GC Adults > 40 Years Old No osteoporotic fractures FRAX MOF < 10% FRAX Hip < 1% Adults < 40 Years Old No osteoporotic fractures

8 ACR-GIOP: First Evaluation Adults > 40 Years Old FRAX with GC Dose Correction BMD within 6 months of GC Rx Adults < 40 Years Old BMD within 6 months of GC Rx IF h/o osteoporotic fracture OR other risk factors

9 FRAX Correction for GC Dose For GC Dose > 7.5 mg Prednisone Equivalent/Day: Multiply MOF Risk by 1.15 Multiply Hip Risk by 1.2 L Buckley Arthritis Care Res 2017; doi /acr.23279

10 Re-Assessment: Patients < 40 Years Old Clinical assessment every year BMD every 2 or 3 years only if: History of Osteoporotic Fracture OR Z-score < -3 at hip or spine OR > 10%/year loss at spine or hip BMD OR Very high dose GC Rx OR Other osteoporosis risk factors

11 Re-Assessment: Patients > 40 Years Old Clinical re-assessment every year If no h/o treatment FRAX every 1-3 years with BMD if available Clinical assessment yearly If OP Rx has been completed (e.g. patient stopped GC) BMD every 2-3 years

12 Re-Assessment: Patients > 40 Years Old Clinical re-assessment every year While on Osteoporosis Treatment, BMD every 2-3 years ONLY IF: Very high dose GC OR OP Fracture at least 18 months after starting OP Rx OR Poor medication adherence OR Other Osteoporosis risk factors

13 Initial Rx: For All Adults including Low Risk Adults > 40 years old Calcium intake of mg/day, preferably in diet Vitamin D units/day Smoking cessation, limit EtOH Weight bearing or resistance exercise

14 Initial Rx: Moderate Risk: Adults > 40 years old Add oral bisphosphonates Prefer to: IV bisphosphonates more risk Teriparatide cost and injection burden Denosumab lack of safety data in immunosuppressed patients Raloxifene lack of data in GIOP and potential clotting harms

15 Initial Rx: High Risk Adults > 40 years old Add oral bisphosphonate Prefer to: IV Bisphosphonate more risk Teriparatide cost and injection burden Denosumab lack of safety data in immunosuppressed patients Raloxifene lack of data in GIOP and potential clotting harms

16 Initial Rx: Low Risk Patients < 40 Years Old Dietary Calcium Vitamin D Exercise

17 Initial Rx: Moderate to High Risk < 40 Y.O. Add oral bisphosphonate Prefer to: IV Bisphosphonate higher risk profile Teriparatide cost and injection burden Denosumab lack of safety data in immunosuppressed patients

18 Rx in Women of Childbearing Potential at Moderate to High Risk Add oral bisphosphonate Second line Rx: teriparatide Third line: IV bisphosphonates, teriparatide Use contraception

19 What Ifs for Patients > 40 Years Old If Fracture or 10%/year bone loss after 18 months of oral bisphosphonate and still on GC Teriparatide or denosumab or IV bisphosphonate If still on GC after 5 years of oral bisphosphonate Continue oral bisphosphonate or switch to IV or other Rx If off GC and now at low risk Stop oral bisphosphonate, continue calcium and D If off GC but still at moderate to high risk Complete course of osteoporosis Rx

20 Pathophysiology of GIOP Early increase in bone resorption Early and profound decrease in bone formation Increase of fracture risk as early as 3 months of GC Rx Osteoblasts are turned off: Anabolics turn on osteoblasts Other pathophysiology less important Decreased muscle strength Hypercalciuria Hypogonadism

21 Teriparatide vs. Alendronate in GIOP 3 Year Study in 428 women and men Fracture Type Alendronate (n = 214) TPTD (n =214) P Value > 1 morphometric vertebral > 1 clinical vertebral (n = 169/173) 13 (7.7%) 3 (1.7%) < (2.4%) 0 < 0.05 > 1 non-vertebral 15 (7.0%) 16 (7.5%) NS > 1 non-vertebral fragility 5 (2.3%) 9 (4.2) NS KG Saag Arthritis Rheum 60:3346, 2009

22 ACR-GIOP Conclusions 15 Slides to Explain Guideline Who is going to read it? Many docs prescribe glucocorticoids! Not much different from 2010 version Value judgement in preferring oral bisphosphonates Chose to ignore pathophysiology of GIOP and apparent superiority of anabolic Rx for high risk patients.

23 New Findings in GIOP Increased risk of fracture with short courses of GC Effects of inhaled glucocorticoids Use of denosumab (off label) in GIOP Alendronate decreases hip fracture risk in GIOP Lack of adherence to GIOP Guidelines

24 Fracture Risk May Increase Within 1 Month! Observational study from large insurance database / adults receive a short course of GC (<30 days) Fracture Risk 1.87 ( ) on days 5-30 Risk gradually decreased in days AK Waljee, BMJ 2017;357:j1415

25 Inhaled GC and GIOP In asthma: higher GC doses higher fracture risk In COPD: less dose response Short courses of oral glucocorticoids are common in patients on inhaled glucocorticoids! SA Sutter, Curr Osteoporos Rep 14:106, 2016

26 Denosumab in GIOP (off label) Small studies show that denosumab increases bone density in spine and hip in GIOP No fracture data yet M Sawamura, Intern Med 56:631, 2017; S Ishiguro, Arch Osteoporos 12:44, 2017

27 Alendronate decreased hip fractures Retrospective cohort study >65 years; >5mg prednisolone for >3 months 1802 had Rx for alendronate 50 after at least 3 months of GC propensity-matched 30 controls no alendronate 20 Follow up median: 1.32 years 10 0 Following Guideline worked! No ALN Fractures ALN Fractures KF Axelsson, JAMA 318:146, 2017

28 Improving Adherence to GIOP Guideline Interventions aimed at patients Interventions aimed at providers Interventions aimed at both System-wide interventions G Mazziotti, Endocrine 54:603, 2016

29 Patient Video Patients with online prescription program Video automatically came up at time of refill versus no video at time of refill 59% viewed at least some of the video No change in receiving osteoporosis Rx. AH Warriner, J Rheumatol 42:1478, 2015

30 Videos for Patients 2.95 % Rx % Rx Video No Video AH Warriner J Rheumatol 42:1478, 2015

31 Multifaceted Intervention Rheumatologists randomized to: Lecture, Audit, and Reminder Mailing OR No intervention No increase in DXAs ordered No increase in osteoporosis Rx DH Solomon, Arthritis Rheum 51:383, 2004

32 Effect of Education Education % Rx No Education % Rx DH Solomon Arthritis Rheum 51:383, 2004

33 Where to Look for the Answer: It s in the old literature!

34 Geisinger Clinic Plan Three Sources to Identify GIOP Patients Self referral (advertisements in clinics) Clinician referral (via electronic record) Database search by Nurse Make the FLS Nurse be the GIOP Nurse! Dramatic DXA and Rx ED Newman, Osteoporos Int 17:1428, 2006

35 Change in Rx % Rx Baseline All - 6 months All - 1 year Hi Risk - 6 mo. Hi Risk - 1 yr. % Rx ED Newman, Osteoporos Int 17:1428, 2006

36 Suggested Approach Have the FLS Nurse become the GIOP Nurse Get approval from clinicians Once weekly printout of new GC Rxs Contact the patients (similar to FLS) Assess fracture risk by history Order a DXA Assure adequate calcium and D Start treatment Alert the primary clinician

37

38

39 Long Term Bisphosphonate Rx J Bone Miner Res 31:16-35, 2016

40

41

42 Adler s Approach: Duration of Bisphosphonate Rx 5 years of oral Rx for high fracture risk i.v. zoledronic acid q months = 5 years of Rx Clinical assessment annually; DXA at 2-3 years At 5 years, assess fracture risk again DXA (T < -2.5), history of fracture Side effects risks predictable? Other factors Meds (e.g. continuing glucocorticoids, ADT, Aromatase Inhibitors) Falling and frailty Competing causes of mortality Assess again periodically RA Adler J Bone Miner Res 31:16, 2016; RA Adler Endocrine 51: 222, 2016 J Ward Osteoporos Int 27:2681, 2016; A Gustafsson Bone 88:125, 2016

43 Reduced Bisphosphonate Prescription Rates Starting in 2008 S Jha, J Bone Miner Res. 2015;30:

44 Nonadherence Must take 75-80% of Rx in order to show fracture ~50% of patients still on Rx at 1 year Reasons for poor adherence No symptoms: osteoporosis is silent until fracture Complex dosing regimens Cost no longer a problem Concern about side effects MI Williams & VI Petkov in RA Adler, ed, Osteoporosis-2nd Ed, 2010.

45 DXA, Diagnosis, Reimbursement 26% 24% Percent of Women Age % 20% 18% 16% 14% 12% DXA Medicare Payments $139 Osteoporosis Diagnosis DXA Testing $ % 17.9% $ % 10% 11.3% Direct Research LLC, Medicare PSPS Master Files and Medicare 5 Percent Sample LDS SAF, analysis by Peter M. Steven, PhD.

46 No More Hip Fracture Rate 26% Hip Fracture Rates 900 Percent of Women Age % 22% 20% 18% 16% 14% 12% 884 DXA Medicare Payments $139 Osteoporosis Diagnosis DXA Testing $ % 17.9% % $ Fractures per 100,000 Women Age 65+ Age-adjusted to the 2014 Age Distribution 10% 11.3% 500 Direct Research LLC, Medicare PSPS Master Files and Medicare 5 Percent Sample LDS SAF, analysis by Peter M. Steven, PhD.

47 Drug Prices Per Month Drug U.S. Retail U.S. Veterans Denmark Italy Alendronate - Weekly Risedronate - Monthly Zoledronic Acid Annually Denosumab Q 6 months Teriparatide Daily

48 New Paradigm? How would you treat the high risk patient if: All osteoporosis meds cost the same as generic oral alendronate? Could be prescribed without jumping through hoops? Patient care was based on what is best for the patient?

49 Future Rx for GIOP and Other High Risk? Anabolics first in many cases Add an anti-resorptive Then, after some months, d/c anabolic Re-introduce anabolic temporarily after some period (2-3 years?) while continuing anti-resorptive Do a femoral shaft x-ray on DXA every year

50 DATA-SWITCH Study BZ Leder, Lancet 386:1147, 2015

51 DATA Follow Up Study 0-1 Lumbar Sp Total Hip Fem Neck No Rx Any Rx BZ Leder, Bone 98:54, 2017

52 Vert Fx 8-16 months after Stopping Denosumab: 112 Fractures in 24 Women AD Anastasilakis J Bone Miner Res 32:1291, 2017

53 From: Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With OsteoporosisA Randomized Clinical Trial JAMA. 2016;316(7): doi: /jama Date of download: 4/17/2017 Copyright 2017 American Medical Association. All rights reserved.

54 From: Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With OsteoporosisA Randomized Clinical Trial JAMA. 2016;316(7): doi: /jama Date of download: 4/17/2017 Copyright 2017 American Medical Association. All rights reserved.

55 From: Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With OsteoporosisA Randomized Clinical Trial Date of download: 4/17/2017 Copyright 2017 American Medical Association. All rights reserved.

56 LS: Abalo vs. PLO X 18 mos; then ALN AB then ALN PLO then ALN months 12 months 18 months 25 months F Cosman Mayo Clin Proc 92:200, 2017

57 Non-Pharmacologic Rx Attain Maximal Skeletal Growth Calcium + Vitamin D Fracture Risk Fall Risk Reduction Improve lower body muscle strength Tai chi, yoga, weight-bearing exercise Good vision Walking aids Home safety CM Weaver, Osteoporos Int 27: 367, 2016

58 Maximize the Benefit/Risk Ratio Find the patients most likely to benefit Previous fragility fracture a sentinel event! Glucocorticoids Aromatase inhibitors, ADT, etc. Find those at particular risk for hip fracture Older women hip fracture: 15-20% 1 year mortality Older men hip fracture: 25-35% 1 year mortality Those that survive: half lose independence!

59 ?Minimize Risks for Side Effects? ONJ Poor dental hygiene Invasive dental procedure (e.g., extraction) Atypical Femoral Fractures Active younger woman with osteopenia? East Asian ethnicity? Femoral geometry? Varus angle of femoral neck and shaft? Bowing of femur? Image on DXA machine every year? Z Mahjoub J Bone Miner Res 31:767, 2016; JC Lo Bone 85:142, 2016

60 Long Term Rx: Adler s Approach 2017 Test: Is the patient at risk for fracture? Find patients at risk Test: Mitigate risk factors for side effects? Treat the patient with highest Benefit/Risk Treat in the correct sequence Tell the patient: plan for 5 years of Rx Test again after 2-3 years of Rx Test again at 5 years Talk to the patient at 5 years Test again every 2 years RA Adler, Endocrine 51:222, 2016

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