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Clinical Practice Guidelines AMERICAN ASSOCIATION OF Clinical Practice Guidelines AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS/ AMERICAN COLLEGE OF ENDOCRINOLOGY CLINICAL PRACTICE GUIDELINES FOR THE DIAGNOSIS AND TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS— 2020 UPDATE Pauline M. Camacho, MD, FACE1; Steven M. Petak, MD, JD, FACP, FCLM, MACE, CCD2; Neil Binkley, MD3; Dima L. Diab, MD, FACE, FACP, CCD4; Leslie S. Eldeiry, MD5; Azeez Farooki, MD6; Steven T. Harris, MD, FACP, FASBMR7; Daniel L. Hurley, MD, FACE8; Jennifer Kelly, DO, FACE9; E. Michael Lewiecki, MD, FACE, FACP, CCD10; Rachel Pessah-Pollack, MD, FACE11; Michael McClung, MD, FACP, FACE12; Sunil J. Wimalawansa, MD, PhD, MBA, FCCP, FACP, FRCP, DSc, FACE13; Nelson B. Watts, MD, FACP, CCD, FASBMR, MACE14 The American Association of Clinical Endocrinologists’ Medical Guidelines for Practice are systematically developed statements to assist health-care professionals in medical decision-making for specific clinical conditions. Most of the content herein is based on literature reviews. In areas of uncertainty, professional judgment was applied. These guidelines are a working document that reflect the state of the field at the time of publication. Because rapid changes in this area are expected, periodic revisions are inevitable. We encourage medical professionals to use this information in conjunction with their best clinical judgment. The presented recommendations may not be appropriate in all situations. Any decision by practitioners to apply these guidelines must be made considering local resources and individual patient circumstances. Submitted for publication February 15, 2020 Past President, American Association of Clinical Endocrinologists, Accepted for publication March 2, 2020 9Associate Professor of Medicine, Division of Endocrinology and Diabetes, From the 1Guideline Task Force Co-Chair, Professor of Medicine, Director, Director, Metabolic Bone Program, University of Vermont Medical Center, Loyola University Osteoporosis and Metabolic Bone Disease Center, Burlington, Vermont, 10Director, Bone Health TeleECHO, University of New Maywood, Illinois, 2Guideline Task Force Co-Chair, Associate Clinical Mexico Health Sciences Center, Albuquerque, New Mexico, 11Assistant Professor, Weill-Cornell Medical College, Division Head and Service Chief, Clinical Professor, Division of Endocrinology, Diabetes, and Bone Disease, Endocrinology, Houston Methodist Hospital, Charles and Anne Duncan Icahn School of Medicine at Mount Sinai, New York, New York, 12Founding Centennial Clinical Academic Scholar in Endocrinology, Houston, Texas, Director, Oregon Osteoporosis Center, Portland Oregon, Professional 3Professor of Medicine, Divisions of Endocrinology and Geriatrics, University Fellow, Mary MacKillop Institute for Health Research, Australian Catholic of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, University, Melbourne, Victoria, Australia, 13Division of Endocrinology, 4Associate Professor of Clinical Medicine, Fellowship Associate Program Metabolism and Lipids, Department of Medicine, Emory University School Director, Director of UC Bone Health and Osteoporosis Center, Division of of Medicine and the Atlanta VA Medical Center, Atlanta, Georgia, and Endocrinology, Diabetes and Metabolism, University of Cincinnati College of 14Director, Mercy Health Osteoporosis and Bone Health Services, Cincinnati, Medicine, VA Interim Endocrinology Section Chief, Veterans Affairs Medical Ohio. Center, Cincinnati, Ohio, 5Assistant Professor of Medicine, Harvard Medical Address correspondence to Dr. Pauline M. Camacho, Loyola University School, Staff, Department of Endocrinology, Harvard Vanguard Medical Medical Center, 2160 South First Avenue, Fahey Center, Suite 137, Maywood, Associates/Atrius Health, Boston, Massachusetts, 6Associate Attending IL 60153. Physician, Memorial Sloan Kettering Cancer Center, Endocrinology Service, E-mail: [email protected]. Associate Clinical Professor, Weill Cornell Medical College, Key Clinical Published as a Rapid Electronic Article in Press at http://www.endocrine Faculty, MSKCC-WCMC Endocrinology Fellowship Program, New York, practice.org. DOI: 10.4158/GL-2020-0524 New York, 7Clinical Professor of Medicine, University of California, San To purchase reprints of this article, please visit: www.aace.com/reprints. Francisco, California, 8Consultant, Division of Endocrinology, Diabetes, Copyright © 2020 AACE. Metabolism and Nutrition, Mayo Clinic, Rochester, Minnesota, Immediate Copyright © 2020 AACE ENDOCRINE PRACTICE Vol 26 (Suppl 1) May 2020 1 2 Postmenopausal Osteoporosis Guidelines, Endocr Pract. 2020;26(Suppl 1) Copyright © 2020 AACE high-risk features, a new dual-action therapy option, and Abbreviations: transitions from therapeutic options. 25(OH)D = 25-hydroxyvitamin D; AACE = American Conclusion: This guideline is a practical tool for Association of Clinical Endocrinologists; ACE = endocrinologists, physicians in general, regulatory bodies, American College of Endocrinology; AFF = atypi- health-related organizations, and interested laypersons cal femoral fracture; ASBMR = American Society regarding the diagnosis, evaluation, and treatment of for Bone and Mineral Research; BEL = best evidence postmenopausal osteoporosis. (Endocr Pract. 2020;26 level; BMD = bone mineral density; BTM = bone turn- (Suppl 1):1-44) over marker; CI = confidence interval; CPG = clini- cal practice guideline; CTX = C-terminal telopeptide INTRODUCTION type-I collagen; DXA = dual-energy X-ray absorptiom- etry; EL = evidence level; FDA = U.S. Food and Drug Osteoporosis is a growing major public health prob- Administration; FRAX® = Fracture Risk Assessment lem, with an impact on quality and quantity of life that Tool; GI = gastrointestinal; HORIZON = Health crosses medical, social, and economic lines. These guide- Outcomes and Reduced Incidence with Zoledronic acid lines have been developed by the American Association of ONce yearly Pivotal Fracture Trial (zoledronic acid and Clinical Endocrinologists (AACE) with hopes of reduc- zoledronate are equivalent terms); ISCD = International ing the risk of osteoporosis-related fractures and thereby Society for Clinical Densitometry; IU = international maintaining the quality of life for people with osteopo- units; IV = intravenous; LSC = least significant change; rosis. The guidelines use the best evidence, taking into NOF = National Osteoporosis Foundation; ONJ = consideration the economic impact of the disease and the osteonecrosis of the jaw; PINP = serum amino-termi- need for efficient and effective evaluation and treatment nal propeptide of type-I collagen; PTH = parathyroid of postmenopausal women with osteoporosis. The intent hormone; R = recommendation; ROI = region of inter- is to provide evidence-based information about the diag- est; RR = relative risk; SD = standard deviation; TBS = nosis, evaluation, and treatment of postmenopausal osteo- trabecular bone score; VFA = vertebral fracture assess- porosis for endocrinologists, physicians in general, regu- ment; WHO = World Health Organization latory bodies, health-related organizations, and interested laypersons. ABSTRACT METHODS Objective: The development of these guidelines The AACE Board of Directors approved this is sponsored by the American Association of Clinical 2020 update of the 2016 AACE/American College of Endocrinologists (AACE) Board of Directors and Endocrinology (ACE) Clinical Practice Guidelines for the American College of Endocrinology (ACE) Board of Diagnosis and Treatment of Postmenopausal Osteoporosis. Trustees and adheres with published AACE protocols for Selection of the co-chairs, primary writers, and expert the standardized production of clinical practice guidelines reviewers as well as the logistics for creating this guide- (CPGs). line update were conducted in adherence with the AACE Methods: Recommendations are based on diligent Protocol for Standardized Production of Clinical Practice reviews of the clinical evidence with transparent incor- Guidelines, Algorithms, and Checklists–2017 Update poration of subjective factors, according to established (2017 Guidelines for Guidelines; 2017 G4G) (Tables 1 AACE/ACE guidelines for guidelines protocols. through 4) (1). Methods established by AACE in 2004 Results: The Executive Summary of this 2020 updat- and clarified in 2010, 2014, and 2017 more clearly delin- ed guideline contains 52 recommendations: 21 Grade A eate the mapping of recommendation grades for transpar- (40%), 24 Grade B (46%), 7 Grade C (14%), and no Grade ency and allow for more interpretative flexibility (Tables 1 D (0%). These detailed, evidence-based recommenda- through 4) (1-4). This updated methodology provides for tions allow for nuance-based clinical decision-making that patient-first language, greater detail regarding ratings for addresses multiple aspects of real-world care of patients. evidence, and general oversight of the entire clinical prac- The evidence base presented in the subsequent Appendix tice guideline (CPG) production process. provides relevant supporting information for the Executive All members of the appointed task force and reviewers Summary recommendations. This update contains 368 made disclosures regarding multiplicities of interests and citations: 123 (33.5%) evidence level (EL) 1 (highest), attested that they are not employed by industry. Primary 132 (36%) EL 2 (intermediate), 20 (5.5%) EL 3 (weak), writers submitted contributions to specific clinical ques- and 93 (25%) EL 4 (lowest). New or updated topics in this tions, which were subsequently
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