An estimated 54 million adults in the United States have low bone density or osteoporosis. And about half of all Americans older than 50 are at risk for osteoporotic fracture.
In response to this highly prevalent health problem, the American College of Physicians (ACP) has recommended in an evidence-based clinical practice guideline(annals.org) that physicians offer pharmacologic therapy with a bisphosphonate -- alendronate (Fosamax), risedronate (Actonel, Atelvia) or zoledronic acid (Reclast) -- or the biologic agent denosumab (Prolia) to reduce the risk for hip and vertebral fractures in women who have known osteoporosis.
The AAFP has endorsed the guideline, which includes additional recommendations on the appropriate length of pharmacologic therapy in osteoporotic women and against the use of menopausal estrogen therapy to treat the condition. The guideline also recommends against bone density monitoring during treatment and makes specific recommendations for men with clinically recognized osteoporosis and older women with osteopenia.
- The American College of Physicians (ACP) has issued a clinical practice guideline recommending that physicians treat women with osteoporosis using bisphosphonates or the biologic agent denosumab.
- The AAFP has endorsed the guideline, which also makes recommendations on the appropriate length of pharmacologic therapy and against menopausal estrogen therapy and the use of bone density monitoring during treatment.
- Finally, the ACP guidance offers specific recommendations for osteoporotic men and older women with osteopenia.
The guideline was published May 9 in the Annals of Internal Medicine.
The ACP's Clinical Guidelines Committee, which developed the new guidance, examined the comparative benefits and risks of short- and long-term drug treatments for low bone density or osteoporosis, including prescription medications, calcium, vitamin D and estrogen.
The committee's recommendations were based on a systematic review of randomized controlled trials, systematic reviews, large observational studies (for adverse events), and case reports (for rare events) published between Jan. 2, 2005, and June 3, 2011. The group updated its review to July 2016 using a machine-learning method, and a limited update to October 2016 also was done. The clinical outcomes evaluated were fractures and adverse events.
Evidence was graded according to the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system developed by the GRADE working group.(www.gradeworkinggroup.org)
The ACP previously published recommendations for treating low bone density and osteoporosis to prevent fractures in 2008. The 2017 guideline features additional evidence on treatments to prevent fractures in men and women with low bone density or osteoporosis that have become available since that earlier guideline was published.
The guideline outlines six specific recommendation statements, the first of which is that physicians 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. The committee graded this as a strong recommendation with high-quality evidence.
"Physicians should prescribe generic drugs to treat patients with osteoporosis whenever possible, and they should discuss the importance of medication adherence, especially for bisphosphonates," said ACP President Jack Ende, M.D., in a news release.(www.acponline.org)
Factors that may contribute to poor adherence to these drugs include side effects, the inconvenience of taking them, an absence of symptoms of the underlying disease, comorbid conditions, age and socioeconomic status.
Next, the ACP recommended that physicians treat osteoporotic women using pharmacologic therapy for five years. Continuing treatment after the initial five years may be beneficial for some patients and may be appropriate after reassessing the risks and benefits of continued therapy. This was graded as a weak recommendation with low-quality evidence.
"Although the direct evidence is insufficient to determine the appropriate duration of pharmacologic therapy, most studies that evaluated the benefit of treatment continued therapy for up to five years," the guideline said.
The ACP also recommended that physicians offer pharmacologic treatment with bisphosphonates to reduce the risk for vertebral fracture in men who have clinically recognized osteoporosis -- this also was a weak recommendation based on low-quality evidence.
"The evidence specifically for men is sparse," Ende said. "However, the data did not suggest that outcomes associated with drug treatment would differ between men and women if based on similar bone mineral density, so treatment for men may be appropriate."
Recommendations against certain treatments were also included in the guideline, including a recommendation that bone density monitoring not be conducted during the five-year treatment period in women.
"Current evidence does not show any benefit for bone density monitoring during treatment," the guideline said, grading this as a weak recommendation with low-quality evidence.
Furthermore, the ACP recommended against using menopausal estrogen therapy or menopausal estrogen plus progestogen therapy or raloxifene (Evista) for the treatment of osteoporosis in women. This was graded as a strong recommendation with moderate-quality evidence.
Not only did estrogen treatment show a lack of benefit, but it has been associated with serious harms, such as increased risk for cerebrovascular accidents and venous thromboembolism, the guideline noted.
Finally, the ACP recommended that physicians base the decision to treat osteopenic women 65 and older who are at high risk for fracture on a discussion of patient preferences, fracture risk profile, benefits and harms, and costs of medications. This was a weak recommendation based on low-quality evidence.
Physicians can use their own judgment based on risk factors for fracture, said the guideline, or they can use a risk assessment tool, such as FRAX (the World Health Organization's Fracture Risk Assessment Tool) to predict fracture risk among untreated people with low bone density.
Family Physician's Perspective
Jennifer Frost, M.D., medical director for the AAFP Health of the Public and Science Division, told AAFP News that the Academy followed its strict criteria in endorsing the ACP's guideline.
"We frequently endorse guidelines from the American College of Physicians as they follow a guideline methodology similar to ours," she said. "And, of course, any guideline we endorse needs to be relevant to primary care."
Frost reiterated that the preferred pharmacologic treatment for women with osteoporosis is bisphosphonates or denosumab because these agents show the strongest evidence of reducing fractures.
"It's also recommended that most women receive this treatment for five years, although longer treatment may be beneficial for women at high risk of fracture," she added.
As for the recommendation on men who have osteoporosis, Frost said there wasn't a strong evidence base for the effectiveness of treatment, so the guidance was extrapolated from studies of treatment of women.
"It's assumed that men with (certain bone mineral density levels) will respond similarly to women with similar (levels)," she said. "However, it's important to note that this recommendation is for men with 'clinically recognized osteoporosis,' as there is insufficient evidence to recommend for or against screening for osteoporosis in men."
The ACP guideline is consistent with the AAFP's osteoporosis screening recommendation, which recommends screening women ages 65 and older for osteoporosis, as well as younger women at increased risk for the condition.
Overall, Frost said the ACP's guideline will be a useful tool for family physicians in their daily practice.
"Once a woman is screened, and the diagnosis of osteoporosis is made, this guideline helps clinicians determine the appropriate treatment," she said.
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