Osteoporosis Treatment Receives Updated Guidelines From ACP

The American College of Physicians (ACP) has updated its 2008 guidelines on treating low bone density and osteoporosis to prevent fractures in men and women.¹ This updated guideline is endorsed by the American Academy of Family Physicians and was published in the Annals of Internal Medicine.

The ACP Clinical Guidelines Committee, led by Amir Qaseem, MD, PhD, MHA, leader of the American College of Physicians’ evidence-based medicine and clinical practice guidelines program, based its recommendations on a systematic review of randomized controlled trials, systematic reviews, large observational studies, and case reports published between January 2, 2005, and June 3, 2011.

These guidelines focus on the comparative benefits and risks for short- and long-term pharmacologic treatments for low bone density, including pharmaceutical prescriptions, calcium, vitamin D, and estrogen. The GRADE system (Grading of Recommendations Assessment, Development and Evaluation) was used to grade evidence.

ACP Recommendations on Treating Osteoporosis to Prevent Fractures

Recommendation 1: The ACP recommends clinicians treat osteoporotic women with alendronate, risedronate, zoledronic acid, or denosumab to reduce the risk for hip and vertebral fractures. (Strong recommendation, high-quality evidence)

Recommendation 2: The ACP recommends clinicians treat osteoporotic women with pharmacologic therapy for 5 years. (Weak recommendation, low-quality evidence)

Recommendation 3: The ACP recommends that in men with osteoporosis, clinicians offer pharmacologic treatment with bisphosphonates to reduce the risk for vertebral fracture. (Weak recommendation, low-quality evidence)

Recommendation 4: The ACP recommends against monitoring bone density during the 5-year pharmacologic treatment period in women with osteoporosis. (Weak recommendation, low-quality evidence)

Recommendation 5: The ACP recommends against menopausal estrogen therapy or menopausal estrogen plus progestogen therapy or raloxifene for treating osteoporosis in women. (Strong recommendation, moderate-quality evidence)

Recommendation 6: The ACP recommends that clinicians should decide whether to treat osteopenic women aged 65 years or older who are at high risk for fracture based on a discussion with the patient about her preferences and fracture risk profile, and the benefits, harms, and costs of medications. (Weak recommendation, low-quality evidence)

Analysis

“The first strong recommendation is the most important,” wrote Eric S. Orwoll, MD, from Oregon Health and Science University at Portland, Oregon, in an accompanying editorial.² “Despite the very low rate of serious adverse events with bisphosphonates (the mainstay of osteoporosis therapy), the number of patients being treated has decreased, seemingly because of the inaccurate perception that adverse events are common.³ The updated recommendation and the data that support it may help to reverse this trend.”

Dr Orwoll also noted that the fifth recommendation is a change from the 2008 guidelines. The committee’s rationale was the lack of evidence of effectiveness in the target group: women with osteoporosis.

“Nevertheless, estrogen replacement reduces fractures in postmenopausal women overall, and it is likely to do the same in osteoporotic women. Therefore, although estrogen should not be the first choice for osteoporosis therapy, if a woman is using estrogen for other reasons (such as menopausal symptoms), skeletal benefits can be expected without the addition of a second osteoporosis drug,” he wrote.

The committee also judged the data on teriparatide to be insufficient to recommend it as a first-line therapy, but its anabolic actions have created enthusiasm about its use in those with more severe osteoporosis.

“Teriparatide may be particularly attractive in the setting of sequential therapy, as recently reported in the DATA (Denosumab and Teriparatide Administration)-Switch Trial that studied teriparatide followed by denosumab,” Dr Orwoll wrote.⁴ “A related treatment (abaloparatide) is now being considered by the U.S. Food and Drug Administration and, if approved, will add to the options for treating osteoporosis with anabolic agents.”

Dr Orwoll concluded by noting that there are several guidelines on this topic, and that clinicians should carefully examine the differences between them.^4,5

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References

1. Qaseem A, Forciea MA, McLean RM, Denberg TD; for the Clinical Guidelines Committee of the American College of Physicians. Treatment of low bone density or osteoporosis to prevent fractures in men and women: a clinical practice guideline update from the American College of Physicians [published online May 9, 2017]. Ann Intern Med. doi:10.7326/M15-1361
2. Orwoll ES. Clinical practice guidelines for osteoporosis: translating data to patients [published online May 9, 2017]? Ann Intern Med. doi:10.7326/M17-0957
3. US Department of Health and Human Services. Bone health andosteoporosis: a report of the Surgeon General. Rockville, MD: US Department of Health and Human Services, Office of the Surgeon General; 2004. Accessed April 5, 2017.
4. Cosman F, de Beur SJ, LeBoff MS, Lewiecki EM, Tanner B, Randall S, et al. Clinician’s guide to prevention and treatment of osteoporosis. Osteoporosis Int. 2014;25:2359-2381. doi: 10.1007/s00198-014-2794-2
5. Watts NB, Adler RA, Bilezikian JP, Drake MT, Eastell R, Orwoll ES, et al; Endocrine Society. Osteoporosis in men: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2012;97:1802-1822. doi: 10.1210/jc.2011-3045