ACTIVITY DISCLAIMER DISCLOSURE. Debbie Zeldow. Nathan Falk, MD, CAQSM, FAAFP. Osteoporosis and Osteopenia Prevention and Treatment: PBL

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1 Osteoporosis and Osteopenia Prevention and Treatment: PBL Robin Creamer, DO, CAQGM, FAAFP Nathan Falk, MD, CAQSM, FAAFP Debbie Zeldow ACTIVITY DISCLAIMER The material presented here is being made available by the American Academy of Family Physicians for educational purposes only. Please note that medical information is constantly changing; the information contained in this activity was accurate at the time of publication. This material is not intended to represent the only, nor necessarily best, methods or procedures appropriate for the medical situations discussed. Rather, it is intended to present an approach, view, statement, or opinion of the faculty, which may be helpful to others who face similar situations. The AAFP disclaims any and all liability for injury or other damages resulting to any individual using this material and for all claims that might arise out of the use of the techniques demonstrated therein by such individuals, whether these claims shall be asserted by a physician or any other person. Physicians may care to check specific details such as drug doses and contraindications, etc., in standard sources prior to clinical application. This material might contain recommendations/guidelines developed by other organizations. Please note that although these guidelines might be included, this does not necessarily imply the endorsement by the AAFP. This CME session is supported by an educational grant to the AAFP from Radius Health, Inc. DISCLOSURE It is the policy of the AAFP that all individuals in a position to control content disclose any relationships with commercial interests upon nomination/invitation of participation. Disclosure documents are reviewed for potential conflict of interest (COI), and if identified, conflicts are resolved prior to confirmation of participation. Only those participants who had no conflict of interest or who agreed to an identified resolution process prior to their participation were involved in this CME activity. All individuals in a position to control content for this session have indicated they have no relevant financial relationships to disclose. The content of my material/presentation in this CME activity will not include discussion of unapproved or investigational uses of products or devices. Robin Creamer, DO, CAQGM, FAAFP Assistant Director, Florida Hospital Family Medicine Residency, Winter Park; Assistant Director, Geriatric Medicine Fellowship Program, Florida Hospital, Orlando; Associate Professor, Florida State University College of Medicine, Tallahassee; Assistant Professor, University of Central Florida College of Medicine, Orlando. Dr. Creamer is a graduate of the Chicago College of Osteopathic Medicine, Downers Grove, Illinois, and completed her family medicine residency at Florida Hospital in Orlando. She also recently completed a fellowship in geriatric medicine at Winter Park Memorial Hospital, Florida. Dr. Creamer has been practicing and teaching family medicine for more than 20 years. Following her passion for osteoporosis prevention, she leads a National Osteoporosis Foundation (NOF) support group called Central Florida Healthy Bones and has earned her NOF fracture liaison service certificate. She believes one of family medicine's critical challenges is to motivate patients to be as physically active as possible. Nathan Falk, MD, CAQSM, FAAFP Assistant Director, Sports and Family Medicine Faculty, Florida Hospital Family Medicine Residency, Winter Park, Florida. Dr. Falk is a graduate of the University of Nebraska College of Medicine. He completed his family medicine residency at Offutt Air Force Base (AFB). He served as residency faculty and director of sports medicine at Offutt AFB/University of Nebraska where he was the 2012 Faculty of the Year. Dr. Falk specializes in advanced non-surgical care for musculoskeletal conditions, including evaluation, ultrasound, and injections, as well as medical care of the athlete, ranging from asthma to concussions. Additionally, he has interest in faculty development and teaching residents to teach. He has published numerous chapters, books, and articles on sports and family medicine topics, as well as serving as an expert lecturer from Florida to China. Debbie Zeldow Executive Director, National Bone Health Alliance (NBHA), Arlington, Virginia Zeldow is a graduate of American University, Washington, DC, and earned her Master of Business Administration degree from Johns Hopkins University, Baltimore, Maryland. She joined the NBHA in October 2013, bringing more than 20 years of experience in nonprofit management and executive leadership to the organization. The NBHA is a public-private partnership that brings together the expertise and resources of its 55 member organizations, as well as liaisons from a number of government agencies, to collectively promote bone health and prevent disease; improve diagnosis and treatment of bone disease; and enhance bone research, surveillance, and evaluation. The organization s signature initiatives include the 2Million2Many ( osteoporosis awareness campaign, and Fracture Prevention CENTRAL ( a resource that enables the development and implementation of fracture prevention programs. 1

2 Learning Objectives 1. Practice applying new knowledge and skills gained from Osteoporosis and Osteopenia Prevention and Treatment sessions, through collaborative learning with peers and expert faculty. 2. Identify strategies that foster optimal management of osteoporosis/osteopenia, within the context of professional practice. 3. Formulate an action plan to implement practice changes, aimed at improving patient care. Associated Sessions Osteoporosis and Osteopenia Prevention and Treatment: Providing Un-Fractured Care Audience Engagement System Step 1 Step 2 Step 3 Problem Based Learning Outline Review osteoporosis educational resources Apply the WHO FRAX fracture risk tool Discuss barriers to prescribing osteoporosis medications Review resources and recommendations for fall prevention Discuss post fracture coordination of care Educational Resources National Osteoporosis Foundation(NOF) Professional Learning Center; Clinicians Guidelines; FRAX: or APP National Bone Health Alliance: National Institute of Health (NIH); Mayo Clinic Shared Decision-Making National Resource Center. - University New Mexico. Telementoring Bone Health TeleECHO Clinic. AAFP Provide Un-fractured care: Screen BMD NCQA HEDIS measure: Number of women 65 who report ever having a BMD test. USPSTF and Choosing Wisely Recommend: All women 65 years Younger women whose fracture risk is equal to or greater than that of a 65-year old white woman who has no additional risk factors = FRAX estimated 10 year risk 9.3% for a major osteoporotic fracture. Men: Evidence is insufficient to recommend screening in men without previous fractures or secondary causes of osteoporosis. 2

3 FRAX as decision tool for who to screen with DXA 55 yo white female; BMI 24(wt 140;ht 63) Personal history of distal fibula fracture from falling off curb Mother with history of hip fracture No other risks > 9.3% FRAX as decision tool for who to screen with DXA 64 yo black female; BMI 24(wt 140;ht 63) Personal history of radial fracture from slipping on pool deck No other risk < 9.3% FRAX as decision tool for who to screen with DXA 68 yo white male; BMI 23.7 (wt 165;ht 70) Drinks a 6 pk a day; Alcoholic liver disease No other risk > 9.3% 3

4 Provide Un-fractured care: Repeat DXA Repeat DXA interval depends on initial BMD. If no risk factors: - Normal DXA T score >-1.49, repeat yrs or more - T score to -1.99, repeat in 3-5 years - T score -2.0 or less, repeat in 2 years Consider Pharmacologic Therapy Postmenopausal women and men 50 yrs with a Hip or Vertebral fragility fracture OR T-score Femoral neck, total hip, or spine OR T-score between -1.0 and -2.5 and FRAX scores: Major 20% or Hip 3% 10-year fracture risk FRAX as decision tool for Treatment for Low Bone Mass osteopenic patients 70 yo WF BMI 20.6 (110#; 63 ) Lifetime height loss 2 inches Risks: no risk DXA T score LS -2.4; FN -2.2; TH -2.1 Major <20% Hip < 3.0% Vertebral Fracture Assessment T10 Vertebral Compression Fracture Major <20% Hip > 3.0% FRAX as decision tool for Treatment for Low Bone Mass osteopenic patients 75 yo WF with history of humeral fracture from fall home reaching for thermostat BMI 20.6 (120#; 64 ) Risks: prior fracture; tobacco DXA T score LS -2.4; FN -2.3; TH

5 Case Hip > 3.0% 75 yo female presents to office Fell in the bathroom and broke left hip Feels her bones are fine, floor very hard Fixed by ortho and was in SNF for 2 wks Discharged yesterday Case PMHx HTN GERD, esophageal stricture dilated 6 months ago Meds Metoprolol succinate 50 mg, omeprazole 20 mg, ASA 81 mg daily, calcium carbonate 600 mg bid Family history: mother history of hip fracture Social history: No alcohol or tob; no routine exercise Diet: cardiac, low fat. Case Vitals and Exam BP 135/85, HR 80, RR 16, BMI 20.6 (Wt 120; Ht. 64 ) RRR, Lungs CTA Walking with walker Case Visit Plan Home Health orders and Face/Face forms completed Discuss connection between fractures and osteoporosis. Provide education on Universal Bone Health precautions, modifiable risks, treatment.. AES POLL QUESTION Time as Barrier to Providing Un-fractured Care Share ideas for efficiency in providing patient education. Evaluate her risk factors and non-pharmacologic recommendations to modify them. What labs do you order to screen for secondary causes? 5

6 Part 1 of Response to Time as Barrier to Providing Unfractured Care: Ideas and resources to provide patient education Online resources- NOF Refer to Physical Therapy and Registered Dietician CPT code Chronic Care Management for staff Start an NOF Support Group / Lecture Series NOF Professional Learning Center Part 2 of Response to Time as Barrier to Providing Unfractured Care: Evaluate her risk factors: age, sex, family hx hip fracture, PPI, no exercise Exercise needed for bone strength and fall prevention Calcium Citrate if needs supplement to meet RDA What labs do you order to screen for secondary causes? Vit D, CMP, CBC, TSH, ipth, Mg, Phosph Universal Recommendations for Bone Health Regardless of Bone Density Advise adequate dietary calcium intake, supplement if diet is insufficient Advise adequate Vitamin D intake, supplement if diet is insufficient Avoid Tobacco and excess alcohol Recommend exercise program for strength, posture and balance Fall Prevention Too Fit To Fracture Recommendations For preventing bone loss and falls, recommend a combination of: Strength training for major muscle groups 2x/week Balance challenges daily Moderate-to-vigorous aerobic physical activity 150 min/week, or min per day To reduce spine loads, recommend: Exercises for back extensor muscles daily Spine sparing strategies hip hinge for bending, step-toturn instead of twisting, holding loads close to body Giangregorio LM, et al Osteoporos Int Safe Movement for Spinal Protection National Osteoporosis Foundation 6

7 Spinal Extension Exercises Fall Prevention Resources National Osteoporosis Foundation Provide Un-fractured care: after a Fracture NCQA HEDIS measure: Number of women yrs who suffered a fracture and who had either BMD or a prescription for a drug to treat osteoporosis. In adults 50 yrs,after a fracture, assess FRAX risk Why order a DXA after a hip fracture? Hip fracture alone provides dx of osteoporosis DXA to evaluate effectiveness of treatment Insurance companies require for PA forms. Case: DXA results T score Lumbar Spine(LS) T score Femoral Neck(FN) T score Total Hip(TH) Osteoporosis defined by both Hip fracture & BMD. VFA and FRAX not needed for treatment decision For the curious: FRAX Major 44% / Hip 31% AES POLL QUESTION Barrier to Un-fractured Care: Patient Concerns and Compliance with Medications Patient states her dentist advises his patients against taking osteoporosis medications. How do you discuss risks of medications? What Shared Decision Aid Tools do you use? Mayo Shared Decision Aid Used with permission from Victor Montori,M.D., Mayo Clinic 7

8 Medication NNT % NNH Bisphosphonates in PMW with prior fractures or very low BMD BP meds for 5 years to prevent death, MI, stroke 1/20 prevent vertebral fracture 1/100 prevent hip fracture 1 in 125 were helped (prevented death) 1 in 67 were helped (prevented stroke) 1 in 100 were helped (prevented heart attack*) 94% saw no benefit after 3 years of treatment 5% avoided a vertebral fracture 1% avoided a hip fracture 97% saw no benefit 0.8% were helped by preventing death 1.5% were helped by preventing stroke 1.0% were helped by preventing heart attack A small number were harmed 1 in 10 were harmed (medication side effects, stopping the drug) Case: High Risk Fracture. Medication Options Labs normal: Vit D, CMP, CBC, Mg, Phosp, ipth,tsh Unable to take oral bisphosphonates (BPs) due to esophageal stricture. Options: IV zoledronic acid Denosumab Teriparatide or Abaloparitide x 2 years followed by anti-resorptive Decides to take teriparatide x 2 years, followed by IV Zoledronic acid x 3 years; then assess for drug holiday Interval Care for During Treatment Patients taking medications need to be evaluated annually Calcium, diet, exercise, lifestyle, new meds or chronic diseases Inquire if any thigh or groin pain if on anti-resorptive Exam: height. 2 cm(0.8 in) loss, repeat VFA. Labs: creatinine, calcium, Mg, Vit D DXA interval BMD testing during treatment- no RCT ACP- recommends against testing during 5 yr treatment. - Reduced fractures with treatment even if BMD did not increase NOF: recommends every 2 yrs ISCD: If stable or increased, repeat at 5 years. If BMD decrease 5% Inquire about non-compliance; assess for secondary causes. If poor absorption, switch to IV bisphosphonate Reassess after 5yr oral(bp) or 3yr IV(BP) Interval Evaluation: History (thigh/groin pain) and Physical (height) DXA and Vertebral Fracture Assessment (VFA) No uniform recommendation regarding duration, decisions need to be individualized Women not at high fracture risk after 5 yr of BP treatment, a drug holiday of 2-3 yr can be considered High-risk patients may benefit from treatment >5 yrs FLEX trial alendronate extended 5 10 yrs. Continued prevention of vertebral fractures, but no effect on non-vertebral fracture risk. The risk of AFF, but not ONJ, clearly increases with BP therapy duration, but such rare events are outweighed by vertebral fracture risk reduction in high-risk patients. High- risk patients include: Femoral Neck T score -2.5 Vertebral fractures prior to or during therapy Older women, high FRAX risk Task Force of the ASBMR. Bone Miner Res Jan;31(1)16:-35 Black DM, et al.nejm ; 366: Provide Un-fractured care after a Fracture Barrier: Payment- Insurance Prior Authorizations Solutions: Barrier: Care coordination after a fracture Solutions: Post-fracture Care Coordination National Bone Health Alliance (NBHA) Fracture Liaison Service (FLS) resources American Orthopedic Assoc.: Own the Bone IOF recognition program: Capture the Fracture 8

9 National Bone Health Alliance Overview Launched in late 2010 as a public-private partnership that brings together the expertise/resources of its public, private and non-profit sector partners 55 organizational participants 31 non-profit members 19 private sector members 5 government agency liaisons (CDC, CMS, FDA, NASA, NIH) Collective reach: over 100,000 health care professionals and 10 million consumers Vision: to improve the overall health and quality of life of all Americans by enhancing their bone health Addressing the priorities of the Bone Health Summit National Action Plan: Promote bone health and prevent disease Improve diagnosis and treatment Enhance research, surveillance and evaluation Major NBHA Initiatives (1) Driving the widespread adoption of Fracture Liaison Service (FLS) care coordination programs, led by NP/PA/RN care coordinators that collaborate with the patient s PCP to ensure individuals who fracture receive appropriate screening, diagnosis, treatment (if needed) and support Fracture Prevention CENTRAL ( an online portal on FLS programs, was launched in March over 3,600 registered users resources include over 30 archived webinars, business plans, case studies (all available free of charge) Developed and piloted FLS cloud-based IT/registry tools that enable sites to quickly establish FLS programs and move the needle on major quality measures/improve care coordination (available through NBHA/NOF Osteoporosis Qualified Clinical Data Registry ( only osteoporosis-focused QCDR which enables HCPs to report on osteoporosis and other quality measures Major NBHA Initiatives (2) Testing use of CMS Chronic Care Management CPT code (99490) which provides ~$40/member/month to physicians/other qualified HCPs that perform at least 20 minutes of clinical staff time per calendar month in non-face-to-face care coordination for patients with 2 or more chronic conditions this CPT code has been underutilized (only ~100,000 patients billed to date) major new incentive that can provide greatly needed reimbursement for the FLS Coordinator function/chronic disease care coordination in the primary care setting 2Million2Many Awareness Campaign: In 2012, NBHA launched the 2Million2Many campaign, which focuses on the connection between bone breaks and osteoporosis and the 2 million fractures that occur each year the campaign centers around Cast Mountain, an installation that represents the 5,500 bone breaks that occur each day in the U.S. (2 million per year) there is a variety of free print, video and other materials at Payer Summit::May 2017 DXA Bone Density Payment Reform: Successful. CMS reimburse $ per DXA scan in Increase of $12 instead of a proposed 37% decrease. United States FLS Outcomes 1. Kaiser Permanente Reduced the hip fracture rate expected by over 40% (since 1998) If implemented nationally, Kaiser estimates a similar effort could reduce the number of hip fractures by over 100,000 (and save over $5 billion/year) 2. Geisinger Health System Achieved $7.8 million in cost savings from American Orthopaedic Association Own the Bone Program Achieved statistically significant changes in health professional behavior/referral (calcium and vitamin D, exercise, fall prevention, etc.) Over 190 sites and 22,000+ patients involved from 46 states and the District of Columbia (since mid-2009) $70,000,000 $60,000,000 $50,000,000 $40,000,000 $30,000,000 $20,000,000 $10,000, NBHA Demonstration Project Cloud-Based FLS Application Accessible suite of FLS registry, quality improvement and care coordination tools Delivered through a secure HIPAA-compliant cloud-based platform Cumulative costs (millions $) $0 No intervention Actual results Age group All Savings (millions) $ 7.8 $ 7.2 $ 3.1 -$2.4 AES POLL QUESTION Care Coordination What are barriers to post-fracture osteoporosis care within your current practice? What resources would be helpful to overcome these barriers? How could you incorporate osteoporosis and post-osteoporotic fracture care into practice using chronic disease model/cpt? Idea Sharing Care Coordination 9

10 Practice Recommendations Access osteoporosis educational resources for prevention and treatment of osteoporosis. Apply the WHO FRAX fracture risk tool for screening and treatment Evaluate for risk factors and secondary causes Use Shared Decision Aids Tools Long Term Medication decisions are individualized. Optimize Post-fracture Care Coordination Questions Florida Hospital Family Medicine Residency and Geriatric Medicine Fellowship Robin Creamer, DO, CAQGM, FAAFP Nate Falk, MD, CAQSM, FAAFP National Bone Health Alliance References Adler RA, El-Hajj Fuleihan G, et al. Managing Osteoporosis in Patients on Long-Term Bisphosphonate Treatment:Report of a Task Force of the American Society for Bone and Mineral Research. J Bone Miner Res Jan;31(1): Giangregorio, L. M., et al. "Too Fit To Fracture: exercise recommendations for individuals with osteoporosis or osteoporotic vertebral fracture." Osteoporosis International 25.3 (2014): Mayo Clinic Shared Decision Making National Resource Center. References National Bone Health Alliance. National Committee for Quality Assurance. HEDIS & Performance Measurement. National Institute of Health. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH NIAMS). Osteoporosis. ew.asp National Osteoporosis Foundation(NOF) Professional Learning Resource. References NOF Clinicians Guide to the Prevention and Treatment of Osteoporosis Office of the Surgeon General (US) (2004) Bone health and osteoporosis: a report of the Surgeon General. Office of the Surgeon General (US), Rockville (MD). Available from: Telementoring Bone Health TeleECHO Clinic.University New Mexico. WHO publication - Kanis JA, on behalf of the World Health Organization Scientific Group. Assessment of osteoporosis at the primary health care level. WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield

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