Amir Qaseem, MD, PhD, MHA; Mary Ann Forciea, MD; Robert M. McLean, MD; Thomas D. Denberg, MD, PhD; for the Clinical Guidelines Committee of the American College of Physicians (*)
Note: Clinical practice guidelines are “guides” only and may not apply to all patients and all clinical situations. Thus, they are not intended to override clinicians' judgment. All ACP clinical practice guidelines are considered automatically withdrawn or invalid 5 years after publication, or once an update has been issued.
Disclaimer: The authors of this article are responsible for its contents, including any clinical or treatment recommendations.
Financial Support: Financial support for the development of this guideline comes exclusively from the ACP operating budget.
Disclosures: Dr. Fitterman chairs the test writing committee for internal medicine for the American Board of Internal Medicine and receives a consultation fee for this work. Authors not named here have disclosed no conflicts of interest. Authors followed the policy regarding conflicts of interest described at www.annals.org/aim/article/745942. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-1361. All financial and intellectual disclosures of interest were declared, and potential conflicts were discussed and managed. Dr. Wilt participated in the discussion for this guideline but was recused from voting on the recommendations because of active indirect financial and intellectual conflicts. A record of disclosures and management of conflicts of interest is kept for each CGC meeting and conference call and can be viewed at www.acponline.org/about-acp/who-we-are/leadership/committees-boards-councils/clinical-guidelines-committee/disclosure-of-interests-for-clinical-guidelines-committee.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Requests for Single Reprints: Amir Qaseem, MD, PhD, MHA, American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Qaseem: American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106.
Dr. Forciea: University of Pennsylvania Health System, 3615 Chestnut Street, Philadelphia, PA 19104.
Dr. McLean: Yale School of Medicine, 46 Prince Street, Suite 302, New Haven, CT 06519.
Dr. Denberg: 7480 East 5th Avenue, Denver, CO 80230.
Author Contributions: Conception and design: A. Qaseem, R.M. McLean, T.D. Denberg, M.J. Barry, M. Cooke.
Analysis and interpretation of the data: A. Qaseem, M.A. Forciea, R.M. McLean, T.D. Denberg, M.J. Barry, M. Cooke, R.P. Harris, L.L. Humphrey, D. Kansagara.
Drafting of the article: A. Qaseem, R.M. McLean, T.D. Denberg, M. Cooke, R.P. Harris, T.P. Mir.
Critical revision of the article for important intellectual content: A. Qaseem, M.A. Forciea, R.M. McLean, T.D. Denberg, M.J. Barry, M. Cooke, R.P. Harris, L.L. Humphrey, D. Kansagara, T.P. Mir, H.J. Schünemann.
Final approval of the article: A. Qaseem, M.A. Forciea, R.M. McLean, T.D. Denberg, M.J. Barry, M. Cooke, N. Fitterman, R.P. Harris, L.L. Humphrey, D. Kansagara, T.P. Mir.
Statistical expertise: A. Qaseem.
Obtaining of funding: A. Qaseem.
Administrative, technical, or logistic support: A. Qaseem, T.P. Mir.
This guideline updates the 2008 American College of Physicians (ACP) recommendations on treatment of low bone density and osteoporosis to prevent fractures in men and women. This guideline is endorsed by the American Academy of Family Physicians.
The ACP Clinical Guidelines Committee based these recommendations on a systematic review of randomized controlled trials; systematic reviews; large observational studies (for adverse events); and case reports (for rare events) that were published between 2 January 2005 and 3 June 2011. The review was updated to July 2016 by using a machine-learning method, and a limited update to October 2016 was done. Clinical outcomes evaluated were fractures and adverse events. This guideline focuses on the comparative benefits and risks of short- and long-term pharmacologic treatments for low bone density, including pharmaceutical prescriptions, calcium, vitamin D, and estrogen. Evidence was graded according to the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system.
The target audience for this guideline includes all clinicians. The target patient population includes men and women with low bone density and osteoporosis.
ACP recommends that clinicians offer pharmacologic treatment with alendronate, risedronate, zoledronic acid, or denosumab to reduce the risk for hip and vertebral fractures in women who have known osteoporosis. (Grade: strong recommendation; high-quality evidence)
ACP recommends that clinicians treat osteoporotic women with pharmacologic therapy for 5 years. (Grade: weak recommendation; low-quality evidence)
ACP recommends that clinicians offer pharmacologic treatment with bisphosphonates to reduce the risk for vertebral fracture in men who have clinically recognized osteoporosis. (Grade: weak recommendation; low-quality evidence)
ACP recommends against bone density monitoring during the 5-year pharmacologic treatment period for osteoporosis in women. (Grade: weak recommendation; low-quality evidence)
ACP recommends against using menopausal estrogen therapy or menopausal estrogen plus progestogen therapy or raloxifene for the treatment of osteoporosis in women. (Grade: strong recommendation; moderate-quality evidence)
ACP recommends that clinicians should make the decision whether to treat osteopenic women 65 years of age or older who are at a high risk for fracture based on a discussion of patient preferences, fracture risk profile, and benefits, harms, and costs of medications. (Grade: weak recommendation; low-quality evidence)
Appendix Table 1. Evidence Table for New Randomized, Controlled Trials Identified in the Update
Appendix Table 2. Evidence Table for Post hoc and Subgroup Analyses and Follow-up Studies Identified in the Update
Table 1. The American College of Physicians Guideline Grading System*
Summary of the American College of Physicians guideline on the treatment of low bone density or osteoporosis to prevent fractures in men and women.
BMD = bone mineral density; DXA = dual-energy x-ray absorptiometry; FRAX = World Health Organization Fracture Risk Assessment Tool; GI = gastrointestinal.
Table 2. Summary of Evidence on Pharmacologic Treatments for Low Bone Density and Osteoporosis