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Expert Critique

FROM THE ASCO Reading Room

Anny Wu, D.O. Rheumatologist Adventist Health

It is estimated that approximately 12.3 million individuals in the United States older than 50 years are expected to have osteoporosis by 2020. Osteoporotic fractures, especially hip fractures, are associated with great morbidity and mortality. Patients are often immobilized, suffer greatly from pain, and sustain a prolonged hospitalization. Between 21% and 30% of patients die within one year of such an event.

The United States Preventive Services Task Force (USPSTF) has renewed their recommendation for osteoporosis screening with bone measurement testing for women ages 65 and older. However, the recommendation for screening in younger women is more nuanced. For postmenopausal women younger than age 65, the recommendation is for a risk assessment via score calculations to be done first before bone measurement testing. Score calculation tools include the Fracture Risk Assessment Tool (FRAX), Simple Calculated Osteoporosis Risk Estimation (SCORE), and the Osteoporosis Self-Assessment Tool (OST). Whereas in 2011, the FRAX was specifically recommended, the updated recommendation allows for other options. It is important to note, however, that the FRAX is country specific, accounting for the country鈥檚 epidemiology and also can be used for males. This two step screening recommendation has raised concerns that the process would become inefficient especially in the face of a possible decrease in screening. Whether or not this would improve the identification of female patients at risk for osteoporosis remains to be seen.

Also, the USPSTF statement discussed in this article did not make a recommendation for men to be screened for osteoporosis. However, other major organizations have made recommendations for screening in males age 70 and older. The USPSTF would like to see more data for the effectiveness of treatment in men before making a B recommendation for screening. Despite this, it is known that osteoporosis in men is a preventable burden. Men do have higher fracture-related morbidity and mortality rates than women. It is estimated that 1 in 3 men who experience a hip fracture will die within a year. In particularly vulnerable patients who suffer from an autoimmune disease such as rheumatoid arthritis or ankylosing spondylitis, screening for osteoporosis, regardless of gender, makes sense.

The screening for osteoporosis and subsequent treatment remains effective in decreasing morbidity and mortality in our aging population by identifying patients at risk for fracture. Subsequent medication treatment, lifestyle modifications made to decrease modifiable risk factors and adequate Calcium and Vitamin D intake allow for stabilization of bone marrow density. Hip fracture rates seem to be on the rise since 2013 according to a recent study based on Medicare data. It is unclear whether this is due to decline in use of osteoporosis treatment or whether patients are being screened less in general via dual energy X-ray absorptiometry (DXA) scans. Whether or not screening is made via score calculations alone or via DXA, more needs to be done.

Full Critique

New osteoporosis screening guidelines from the United States Preventive Services Task Force (USPSTF) offered fresh endorsements for screenings in postmenopausal women. Some experts, however, offered pointed criticisms of the guidelines, including their lack of an affirmative recommendation for men.

In response, experts inside and outside USPSTF have provided their perspectives on what the guidelines got right -- and where they may have fallen short.

USPSTF guidelines are closely watched because commercial payers are required to cover any recommendation earning the task force's highest grades of "A" or "B."

The new recommendations, released in June through a statement published in the , update the USPSTF's 2011 guidelines for osteoporosis screening. The task force renewed its B recommendation (meaning moderate certainty of moderate net benefit) for bone measurement testing in women age 65 years or older.

For postmenopausal women younger than 65, the USPSTF conferred another B grade for screenings but stipulated they follow a two-step process: a risk assessment with well-known instruments like the Fracture Risk Assessment Tool (FRAX), Simple Calculated Osteoporosis Risk Estimation (SCORE), or Osteoporosis Self-Assessment Tool (OST), followed by actual bone measurement testing where appropriate.

The 2011 guidelines specifically recommended FRAX as a screening tool. The updated version allows for a wider range of options, contending that FRAX is not demonstrably more effective than other tools.

Younger Women

Under the USPSTF's two-step approach, a physician may choose to proceed with bone measurement testing in a postmenopausal woman younger than 65 years when her 10-year FRAX risk of major osteoporotic fracture is greater than that of a 65-year-old Caucasian woman with no major risk factors.

But not every observer embraced the two-step process. Writing in a , Margaret Gourlay, MD, MPH, of the University of North Carolina at Chapel Hill, cited evidence showing assessments like FRAX do not markedly improve the chances of identifying osteoporosis in that population.

"If complicated risk tools perform no better than age alone to identify screening candidates, women younger than 65 years may be subjected to inefficient screening procedures," Gourlay wrote. "Multiple observational studies have demonstrated that age and weight are as strongly associated with osteoporosis and fracture outcomes as more complicated risk tools."

Gourlay called on the USPSTF to provide an "I" for evidence on screening in women ages 50-64 and help determine an optimal osteoporosis screening approach.

One of the USPSTF statement co-authors, Chien-Wen Tseng, MD, MPH, of the University of Hawaii, said the task force was focused closely on specific evidence and called the process "pretty rigorous and transparent." The findings were based on a systematic review of 168 reports.

"More studies are ... needed that evaluate the direct effect of screening for osteoporosis (either with BMD or clinical risk assessment tools) on fracture outcomes," Tseng and colleagues wrote in the statement. "Additional research is needed to determine whether clinical risk assessment tools alone (without bone mineral testing) could help identify patients at risk of fractures and help guide decisions to initiate medications to prevent fractures."

Men

The USPSTF statement gave an incomplete or "I" assessment to osteoporosis screening in men, explaining that "evidence on the effectiveness of medications to treat osteoporosis in men is lacking," thus precluding a stronger recommendation.

But that assertion did not go unchallenged, nor is it shared by some of the most influential osteoporosis organizations.

"Although some treatments have been found to be effective in preventing fractures in postmenopausal women with osteoporosis, it cannot be assumed that they will be equally effective in men because the underlying biology of bones may differ in men due to differences in testosterone and estrogen levels," the USPSTF statement authors wrote. "The review identified limited evidence on the effect of treatment of men with osteoporosis on the prevention of fractures."

As the USPSTF statement noted, several major organizations recommend bone density testing for men age 70 and older, including the National Osteoporosis Foundation, the International Society for Clinical Densitometry, and the Endocrine Society.

As part of the Choosing Wisely campaign that aims to reduce unnecessary medical procedures, the American Academy of Family Physicians recommends against bone density scans in men younger than 70 years old with no risk factors, but makes no recommendation for men with risk factors or who are 70 years old or older.

Although the USPSTF statement called for more research on the topic, experts contend that sufficient evidence already exists to support a recommendation for screening in older men.

For example, a 2016 study published in the concluded that "expansion of osteoporosis screening for U.S. men to initiate routine screening at age 50 or 60 years would be expected to be effective and of good value for improving health outcomes."

"The [USPSTF] said there was insufficient evidence to screen older men and I was very disappointed by that," said Jane Cauley, DrPH, an epidemiology professor with the University of Pittsburgh. "We don't need another trial to prove it works. Bone mineral testing works in men ... I think [USPSTF members] are purists, but the purist approach is not always the strongest approach."

Tseng emphasized that the USPSTF guidelines do not suggest that screening is a bad idea, but said she and her colleagues wanted to see more information before making a B recommendation or higher, and were particularly focused on what they perceived as a shortage of data on men with no existing osteoporosis symptoms. In other words, for the USPSTF, questions remain around the effectiveness of treatment, not screening.

"Osteoporosis is pretty important in men and it's one of our areas of focus," Tseng said. "This area [of research] says we can accurately detect [osteoporosis] in men. The question is now in treatment of osteoporosis in men who are asymptomatic. Where we have a gap in the evidence is treatment of men who have no fractures."