To reduce the risk of hip and vertebral fractures in women with osteoporosis, physicians should treat them with the bisphosphonates risedronate, alendronate, or zoledronic acid, or alternatively with the biologic agent denosumab.
Dr. Jack Ende, president of the ACP, also urges that, “Physicians should prescribe generic drugs to treat patients with osteoporosis whenever possible and they should discuss the importance of medication adherence, especially for bisphosphonates.”
The revision takes into account evidence on treatments – including new drugs and biologic agents – that has come to light since the 2008 issue of the guidelines.
The new guidelines – which are endorsed by the American Academy of Family Physicians – make six recommendations: two classed as strong because they are backed by high-quality evidence, and four classed as weak because the supporting evidence is of lower quality.
A report on the research that went into the revision, along with the full updated guidelines, is published in the Annals of Internal Medicine.
Osteoporosis is a condition that increases the risk of bone becoming fragile and more prone to fracture. It results from loss of bone mass and deterioration of bone tissue architecture.
Although the condition may affect any bone, it is most likely to occur in the hip, wrist, and spine.
In their paper, the guideline authors describe the huge public health burden of osteoporosis in the United States, where some 54 million people are thought to have osteoporosis or low bone density, and around half of the population of those over 50 is at risk of osteoporosis-related fracture.
As the U.S. population ages, the economic impact of osteoporosis on the healthcare system grows, and estimates suggest that by 2025, this will reach $25.3 billion per year.
The other strong recommendation in the new guidelines, which is backed by “moderate-quality evidence,” is that the ACP advise “against using menopausal estrogen therapy or menopausal estrogen plus progestogen therapy or raloxifene for the treatment of osteoporosis in women.”
The ACP say that the main evidence supporting this advice is that estrogen is linked with increased risk of harms that outweigh the potential benefits. These harms include “cerebrovascular accidents and venous thromboembolic events,” note the guideline authors.
The remaining four recommendations are graded as weak because the supporting evidence is of low quality.
One of these states that the recommended treatment of women with osteoporosis should last for 5 years. The ACP say that, in some cases, it may be beneficial to continue for longer than 5 years, should a reassessment of the risks and benefits support such a decision.
The ACP also advise against monitoring bone density in women during the recommended 5 years of osteoporosis treatment because the evidence suggests that there is no benefit from doing so. However, this is also classed as a weak recommendation due to the low quality of the evidence.
Another recommendation advises physicians to treat men with clinically recognized osteoporosis with bisphosphonates to reduce their risk for vertebral fracture.
This recommendation is classed as weak because the supporting evidence is of much lower quality for men than for women.
In their paper, the guideline authors explain how the quality of evidence relating specifically to men is much thinner.
“Evidence is insufficient regarding the effectiveness of therapies to prevent fractures or treat osteoporosis in men, because few relevant studies have been published,” they note.
Dr. Ende also comments that “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.”
The sixth recommendation concerns the treatment of women aged 65 and older who have osteopenia – a condition in which bone density is lower than it should be, but it is not low enough to be classed as osteoporosis.
The ACP advise physicians that the decision to treat older osteopenic women should follow a discussion of the patient’s preferences, together with other factors such as benefits, harms, medication cost, and fracture risk profile.
However, due to low quality of supporting evidence, this recommendation is also graded as weak.
In a preliminary response to the new guidelines, the National Osteoporosis Foundation (NOF) suggest that physicians treating patients with osteopenia may need more guidance on how to identify higher fracture risk – such as “on the value of DXA [dual-energy x-ray absorptiometry] testing and risk scoring.”
In a wider comment on the strong recommendations, the NOF also note that while “the guidelines may be appropriate for many patients, especially those managed in primary care settings, there are some limitations to these guidelines particularly for patients with special circumstances.”
They suggest, for instance, that there may be situations in which some patients may need to be treated for longer than the recommended 5 years – such as after treatment with denosumab, the use of which, the NOF urge, should not cease abruptly without follow-up therapy because of a raised risk of fractures.
In other cases, the NOF suggest that it may be more appropriate to change the initial treatment or its duration, depending on the level of fracture risk.
The NOF say that they intend to conduct a more in-depth review of the new ACP guidelines, during which they will seek professional and public opinions, in order to help clarify and perhaps extend the scope of the recommendations. The foundation also acknowledges the benefit of the advice, and notes:
“The NOF recognizes the benefits of this report in guiding clinicians in the treatment of osteoporosis, a condition that has seen a 50% reduction of overall therapy since the mid-2000s.”