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Osteoporosis no longer just a woman’s disease

ACP guideline recommends screening for older men

From the June ACP Internist, copyright © 2008 by the American College of Physicians.

By Stacey Butterfield

It was after several male patients came in to her office with non-traumatic fractures that geriatrician Mary P. Harward, FACP, started thinking about screening men for osteoporosis.

“It’s something that I’m just starting to do. With my experience of having picked up osteoporosis in several men who had minimal trauma and had either wrist or foot fractures, I plan to review the literature and add it to my practice as part of my routine screening. It’s something that hasn’t been done routinely in internal medicine and geriatrics practices,” Dr. Harward said.

Many geriatricians and osteoporosis experts agree with Dr. Harward’s assessment, and are encouraging more physicians to undertake routine screening of men. However, physicians still are receiving confusing messages about who and when to screen, as well as which screening methods are the most effective, accessible and cost-effective.

Osteoporosis no longer just a woman’s diseaseThe College’s new guidelines on screening men for osteoporosis, published in the May 6 Annals of Internal Medicine, attempt to clear up some of that confusion. The guidelines urge internists and other clinicians to assess their older male patients for osteoporosis risk factors, especially those over the age of 65. Risk factors to consider include age greater than 70, low body weight (BMI under 20-25kg/m2), weight loss greater than 10%, physical inactivity, corticosteroid use, androgen deprivation therapy and prior fragility fracture.

“Osteoporosis is significantly underdiagnosed, undertreated and underreported in men,” said Amir Qaseem, MD, PhD, senior medical associate for ACP’s clinical programs and quality of care, and lead author of the guidelines. “With the aging population, we’re concerned because the rates of osteoporosis in men are expected to increase by 50% in the next 15 years.”

Who and how to screen

ACP’s evidence review estimated that currently 7% of white men have osteoporosis, 5% of blacks and 3% of Hispanics, and that the rates of its occurrence in men are expected to increase nearly 50% in the next 15 years, while hip fracture rates are projected to double or triple by 2040. By age 65, the guidelines state, at least 6% of men have dual-energy X-ray absorptiometry (DXA)-determined osteoporosis.

However, the precise age to start screening and which methods to use are still uncertain, and physicians largely must use their own judgment about what combination of risk factors merits screening. “The data in men aren’t sufficiently strong that we can make simple rules to accurately say, ‘Screen this person’ and ‘Don’t screen that person.’ At this stage, it is still a subjective interpretation by the physician,” said Paul G. Shekelle, ACP Member, an author of the guidelines and the evidence review on which they were based.

The U.S. Preventive Services Task Force doesn’t address men in its osteoporosis screening guidelines, which are currently under review. This past February, the National Osteoporosis Foundation released its first guidelines on screening men, which call for screening all men 70 and older, in addition to those over 50 who have risk factors for osteoporosis or have had a fracture.

The new ACP guidelines differ in that they find that the appropriate age to start risk assessment is uncertain. “However, by age 65 years, at least 6% of men have DXA-determined osteoporosis, therefore assessment of risk factors before this age is reasonable,” the guidelines state.

In the evidence review, which covered 389 articles and was published together with the guidelines, the researchers found that age and weight were the strongest predictors of the disease in men. “The incidence of osteoporosis goes up as you get older and particularly if you’re thin,” said Dr. Shekelle, who is a staff physician at the West Los Angeles VA Medical Center and a researcher with RAND Health.

The experts make a convincing case for screening older male patients for osteoporosis, but cost is a significant barrier. The ACP guidelines favor DXA as the preferred screening method, but DXA is more expensive than other methods, and the guideline developers did not address issues of cost and access.

DXA is particularly expensive when you can’t get Medicare reimbursement for it, noted W. James Stackhouse, MACP, an internist in Goldsboro, N.C. “Occasionally we can file with documentation of an initial heel screening and get paid, but almost never can we get paid for a DXA in follow-up of men who are on bisphosphonate therapy or have had a pathologic fracture,” he said.

CMS guidelines authorize one DXA every two years for anyone with an X-ray indicating osteoporosis or a vertebral fracture or anyone taking an FDA-approved osteoporosis medication.

However, the rate at which Medicare reimburses for DXA screenings has dropped dramatically in the past few years, according to Brian Whitman, ACP’s associate for regulatory and insurer affairs. “In 2006, if you performed a standard DXA, you would have been paid $139.46. Today, if you did the same thing, you would be paid $82.56.”

The current reimbursement climate has altered the financial considerations involved in purchasing or leasing a DXA machine, which is listed on the Medicare fee schedule at a purchase cost of $85,000.

In the past, screening men for osteoporosis might actually have been a money-maker for some practices, said William B. Applegate, FACP, a geriatrician in Winston-Salem, N.C., “The impetus to do [screening] has actually declined because of declining reimbursement for DXA scans.”

Specialty societies and organizations such as the National Osteoporosis Foundation were particularly upset by the reimbursement changes. Legislation has been introduced to restore the payments to their 2006 levels, said Mr. Whitman.

Other tools on the horizon

It is also possible that less expensive and less cumbersome methods of screening may turn out to be as effective as DXA. The authors of the evidence review looked at the calcaneal ultrasound and found some evidence that it predicted fracture about as well as DXA, but that there just wasn’t enough trial data to recommend it.

“The thing that is prompting people to look at calcaneal ultrasound and other methods is that DXA requires a big machine and requires the patient to go where the big machine is. The calcaneal ultrasound is not much bigger than a hat box and it’s cheaper,” said Dr. Shekelle.

There are also algorithms to evaluate osteoporosis risk: the Osteoporosis Self-Assessment Tool, which the evidence reviewers found insufficiently sensitive and specific, and the World Health Organization’s new FRAX tool online.

FRAX uses bone mineral density at the hip along with nine clinical risk factors to predict a patient’s 10-year risk of a fracture due to osteoporosis.

“This [the FRAX] may be a very powerful tool in men. Unfortunately, most of the published validation of it has been in women,” said Dr. Shekelle.

Research needed

Lack of data is the main stumbling block in the development of guidelines on the topic, the experts said. “This is one of those rare examples in medicine where the inquiries and applications related to men are much less known than those for women,” said Mary Ann Forciea, ACP Member, a guideline author and geriatrician.

The College’s guidelines explicitly state that further research is needed into which risk factors are most significant in men, the potential harms of screening, how cost-effective screening is, and which screening methods work best.

The questions don’t end there, said Dr. Forciea. “Even at the most basic level, are the thresholds that we use for osteoporosis in women the same thresholds we should use for men? We tend to assume that they are, but we don’t know for sure. At what bone density do we see men start to break their hips and have vertebral fractures? Will the medications work as well in men as they do in women?”

The availability of effective medications for osteoporosis is one of the main drivers of this new interest in studying the disease in men. “You think about the original history of osteoporosis and, other than calcium and Vitamin D, the mainstays of treatment were hormones—particularly estrogen—that men just couldn’t take. It wasn’t until the bisphosphonates started being released that we had an alternative therapy for men that was potent,” said David B. Reuben, FACP, director of the geriatrics program at the University of California, Los Angeles.

Advances in prostate cancer treatment, specifically the use of anti-androgen therapy, and general improvement in men’s health also have made it more of an issue, according to Dr. Forciea. “The longevity of men to where they’re going to have osteoporotic problems is a fairly recent phenomenon,” she said.

As with so many of the questions that the experts have about osteoporosis in men, further research is needed. In the meantime, ACP’s guideline writers are at work on their next topic, the treatment of osteoporosis in men and women. Recommendations on that subject should be released in the next couple of months, Dr. Qaseem said.

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Screening for osteoporosis in men: ACP recommendations

  • Periodically perform individualized assessment of risk factors for osteoporosis in older men (strong recommendation; moderate-quality evidence).
  • Obtain DXA for men who are at increased risk for osteoporosis and are candidates for drug therapy (strong recommendation; moderate-quality evidence).
  • Further research to evaluate osteoporosis screening tests in men is needed.

The guidelines are online at www.annals.org.

PIER also has point-of-care modules on screening for osteoporosis and about osteoporosis.

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