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Osteoporosis in Primary Care: Assessment, Treatment, and Education

This educational content, developed by ASBMR and expert faculty, provides primary care physicians with the knowledge and tools to assess the risk factors for osteoporosis, improve patient treatment, and enhance care.

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Osteoporosis in Primary Care: Assessment, Treatment, and Education

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  1. Educational Content Developed by ASBMR and the Faculty Listed Below Stuart L. Silverman, MD, FACP, FACR (Chair) Medical Director Cedars-Sinai Bone Center of Excellence Los Angeles, California Cheryl L. Lambing, MD, FAAFP Clinical Professor University of California, Los Angeles Los Angeles, California E. Michael Lewiecki, MD, FACP, FACE Clinical Assistant Professor of Medicine University of New Mexico School of Medicine Albuquerque, New Mexico Michael McClung, MD, FACP, FACE Director Oregon Osteoporosis Center Portland, Oregon Ethel S. Siris, MD Madeline C. Stabile Professor of Clinical Medicine Columbia University New York, New York Nelson B. Watts, MD, FACP, MACE Director Mercy Health Osteoporosis and Bone Health Services Cincinnati, Ohio

  2. ASBMR and The France Foundation Osteoporosis Education for the PCP? • Curriculum for PCPs • AAFP chapter meetings • www.osteocme.org

  3. Learning Objectives • Improve the ability to assess risk factors for osteoporosis and apply evidence-based screening recommendations to these at-risk patients within one’s practice • Develop strategies to improve the treatment of patients with osteoporosis • Utilize the tools and other information provided within this initiative, including patient education tools and systems-based approaches to facilitate improving the assessment and care being provided to patients with osteoporosis

  4. Postmenopausal Osteoporosis in the Primary Care Setting • What is osteoporosis? • Why you should care? • Whom to test and how? • Whom to treat and how?

  5. Definition of Osteoporosis • A skeletal disorder characterized by • Compromised bone strength predisposing to • An increased risk of fracture • Bone strength reflects the integration of two main features: • Bone density • Bone quality Normal Bone Osteoporotic Bone 2000 NIH Consensus Development Conference

  6. Osteoporosis Is a SeriousPublic Health Problem • Affects 10 million Americans (80% women) • 2 million fractures yearly • Direct cost $17 billion Distribution of Fractures

  7. Osteoporosis in Perspective

  8. Osteoporosis in PerspectiveLifetime risk at age 50

  9. Identified Treatment GapNCQA HEDIS *2011 HMO Rates NCQA State of Healthcare 2012 - HMO Statistics (Commercial or Medicare data from 2011). http://www.ncqa.org/Portals/0/State%20of%20Health%20Care/2012/SOHC%20Report%20Web.pdf. Accessed February 2013.

  10. National Osteoporosis Foundation 2013 Guidelines • Universal (risk, diet, vitamin D, exercise, smoking, monitoring) • Diagnosis (BMD, vertebral imaging, causes of secondary osteoporosis) • Monitoring (BMD) • Treatment (initiation criteria, options, duration) Major clinical recommendations http://www.nof.org/hcp/practice/tools. Accessed March 2013.

  11. Who Should Have a Bone Density Test? AAFP1 and NOF2 1. Sweet MG, et al. Am Fam Physician. 2009;79(3):193-200. 2. National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. www.nof.org. Accessed February 2013.

  12. Reimbursement for DXAFinal Rule Since 2006, Medicare covers bone densitometry for five indications • Estrogen-deficient women at clinical risk for osteoporosis • Patients with vertebral abnormalities • Patients receiving long-term glucocorticoids (prednisone ≥ 5 mg/d or equivalent for 3+ months) • Patients with primary hyperparathyroidism • Patients being monitored to assess the response to an approved drug Federal Register. 2006;71(231):67783-67784.

  13. WHO Criteria forPostmenopausal Osteoporosis The T-score compares an individual’s BMD with the mean value for young adults and expresses the difference as a standard deviation score.

  14. Whom to Treat: NOF Guidelines 2013 Women ≥ 65 and men ≥ 70 (younger with risk factors) DXA test T-score ≤ -2.5 in the lumbar spine, total hip, or femoral neck or Hip or spine fracture (clinical or radiographic) T-score between -1.0 and -2.5 and increased fracture risk FRAX 10-y fracture risk YES ≥ 3% for hip fracture or ≥ 20% for major osteoporotic fractures YES Candidate for TREATMENT http://www.nof.org/hcp/practice/tools. Accessed March 2013.

  15. Web Version 3.4

  16. Clinical Benefits of FRAX

  17. Limitations of FRAX Watts NB, et al. J Bone Miner Res2009;24:975-979.

  18. Patient Care Goals • Identify patients at risk of fractures • Reduce incidence of fractures • Maintain quality of life • Activity • Independence • Health

  19. Counsel on the risk of fractures Eat a diet rich in fruits and vegetables (supplemented if necessary) to a total calcium intake of 1000 mg per day for men 50-70 1200 mg per day for women ≥ 51 1200 mg per day for men ≥ 71 Vitamin D intake should be 800-1000 IU per day, supplemented if necessary (age ≥50) Regular weight-bearing and muscle-strengthening exercise Fall prevention evaluation and training Universal Recommendations for Bone Health http://www.nof.org/hcp/practice/tools. Accessed March 2013.

  20. FDA-approved Medications

  21. Evidence for Fracture Reduction Adapted from Murad MH, et al. J Clin Endocrinol Metab. 2012;97(6):1871-1880.

  22. Clinical Benefit of Bisphosphonates • Relative risk reduction for fractures • Postmenopausal women with osteoporosis • 3 years bisphosphonate treatment Vertebrae Hip Khosla S, et al. J Clin Endocrinol Metab. 2012;97(7):2272-2282.

  23. BisphosphonatesSide Effects/Safety Concerns • Oral formulations may cause esophageal irritation • Can cause acute phase response (IV and high-dose oral) • Contraindicated in patients with hypocalcemia • Limited to patients with good kidney function (GFR > 30 or 35 mL/min) • Musculoskeletal pain? • Osteonecrosis of the jaw? • Atypical femur fractures?

  24. Bisphosphonates have a long residence time in bone Does long-term treatment create safety concerns that limit the duration of treatment? Given the long retention in bone, with release and possibly recycling of drug, does cumulative exposure lead to a reservoir in bone, so that after therapy is stopped, sufficient drug will be released to exert a continuing benefit? How Long Should Bisphosphonate Treatment Last? Porras AG, et al. Clin Pharmacokinet. 1999;36(5):315-328. Watts NB, et al. J Clin Endocrinol Metab. 2010;95(4):1555-1565.

  25. Long-term Experience with AlendronateFit Long-term Extension (FLEX) Study 5-year extension to 5 year alendronate trial Alendronate patients re-randomized Continue alendronate (n = 662) Switch to placebo (n = 437) Results Clinical vertebral fractures were reduced by 55% overall in continuation group Nonvertebral fractures were reduced by 50% in continuing women with T-scores -2.5 or below at the start of FLEX Schwartz AV, et al. J Bone Miner Res.2010;25:976-982.

  26. Clinical Vertebral Fractures in the FLEX Study 6 5.3% ALN 5 years  Placebo 5 years 5 Alendronate 10 years 4 RR  55% P = 0.013 Cumulative Incidence of Fractures (%) 3 2.4% 2 1 0 0 1 2 3 4 5 Years Since FIT ALN/PLB 437 428 429 421 417 414 ALN/ALN 662 659 657 654 650 646 Black DM, et al. JAMA. 2006;296:2927-2938.

  27. How Long to Treat with Bisphosphonates? • 5–10 years appears to be safe for most patients • Assess for risk: Lower Risk Higher Risk Drug Holiday After 3-5 years Drug Holiday After 10 years Watts NB and Diab D. J Clin Endocrinol Metab. 2010;95(4):1555-1565.

  28. Denosumab • Human monoclonal antibody to RANKL • Decreases osteoclast number and function • Reduces risk of spine, hip and nonvertebral fractures • For osteoporosis, SQ dosing every 6 months • No dose adjustment for decreased kidney function • Effect is reversible within 6–12 months of stopping Cummings SR, et al; FREEDOM Trial. N Engl J Med. 2009;361(8):756-765. Jiang X, et al. Menopause. 2013;20(2):117-119.

  29. Differences Among Antiresorptive Agents

  30. Teriparatide • Recombinant human PTH (rhPTH [1-34]) • Mechanism of action different from other agents (anabolic) • Daily SC injection • Indicated for patients at high risk for fracture • Postmenopausal women with osteoporosis • Men with primary or hypogonadal osteoporosis • Men and women with osteoporosis associated with sustained systemic glucocorticoid therapy • Treatment limited to 2 years, follow with antiresorptive agent Forteo PI. http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021318s012lbl.pdf. Accessed Feb 2013. Han SL, Wan SL. Int J Clin Pract. 2012;66:199-209.

  31. Monitoring • Monitor with DXA every 1–2 years • Do not "over-interpret" change • Be happy when BMD is stable OR increasing • Why do some patients lose BMD on treatment? • Adherence • Drug pharmacokinetics • Underlying disorders that need to be addressed • Patients on treatment whose BMD remains low are at high risk of fracture and may benefit from longer treatment

  32. Secondary Fracture Prevention A fracture is a sentinel event A fracture in a person over 50 is the most powerful risk factor for a future fracture Many high risk patients have the fracture successfully treated but do NOT receive subsequent medical assessment and treatment to prevent the next fracture

  33. Where Are We Now? The Good News

  34. Where Are We Now? The Bad News Ross S, et al. Value Health. 2011;14(4):571-581. Reynolds K, et al. Osteoporos Int. 2013 Apr 18. [Epub ahead of print].

  35. What Can I Do as a PCP?Practical Steps • Patient Dialog • Risk/benefit communication • Shared decision making • Decision Aids • Electronic med records • Checklist for risk • Handouts • Web resources • Engage the Care Team • Counseling, follow-up • ID high-risk patients • Manage Nonadherence • Identify individual barriers • Address barriers

  36. Fall Prevention • Improve lighting • Remove loose rugs • Add grab bars near bathtubs, toilets and stairways • Formal home safety evaluation • Physical therapy for core strength and balance • Eliminate medications that can affect alertness and balance • Assistive device evaluation and training Sweet MG, et al. Am Fam Physician. 2009;79(3):193-200.

  37. What Can I Do as a PCP?Performance Improvement Activities (PI-CME)

  38. Performance Improvement CME • MOC Part IV Approved • American Board of Family Medicine (ABFM) https://achsos.community360.net https://achsos.community360.net/default.aspx. Accessed April 2013.

  39. Performance Improvement CME • MOC Part IV Approved • American Board of Internal Medicine (ABIM) www.pi-iq.com/osteoporosis2

  40. Update on Management of Osteoporosis

  41. Online Tools and Resources • www.osteoCME.org • FRAX • AAFP guidelines • NOF Clinician’s Guide 2013 • ACP treatment guidelines 2008 • NBHA resource center for Fracture Liaison Services

  42. www.osteoCME.org

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