Osteoporosis, which affects an estimated 54 million men and women in the United States, leads to an increased risk for bone fragility and fracture, especially in the hip, spine and wrist.
"The previous guidelines were much more general," said Dr. Robert McLean, a member of the American College of Physicians' clinical guidelines committee, which wrote the advisory, and an associate clinical professor of medicine at Yale School of Medicine.
The 2008 opinion was working with less data on medication options, including duration of use, he said. The new advisory uses fresh data to guide doctors to prescribe bisphosphonates or denosumab for five years. Bisphosphonates include Fosomax, Reclast and Zometa to name a few and denosumab
is sold under the brand names Prolia and Xgeva.
Recommending fewer screenings
"Bisphosphonates are medications that have been used for many years that act largely by inhibiting resorption of bone," McLean wrote in an email. Resorption is the breakdown of old bones by osteoclasts, a type of bone cell. Bisphosphonates act directly on osteoclasts.
"Denosumab also decreases bone resorption by inhibiting maturation of osteoclasts through binding to a receptor on the surface of 'pre-osteoclast cells,' " McLean said. This synthetically made antibody cannot be taken orally; it needs to be given as a subcutaneous, or just below the skin, injection every six months, he said.
The updated guidelines also instruct doctors on what not to do.
"There is now a specific recommendation against using estrogen replacement therapy or raloxifene (Evista) for treatment of osteoporosis in women," said McLean, who is also a practicing rheumatologist/internist. The potential side effects of these treatments influenced the committee to favor other options, which can provide greater benefits with fewer risks.
The committee also put the kibosh on frequent screening of patients with normal bone density, since most measurements don't change within 15 years.
"There is now a more specific recommendation for shared decision-making with patients in the specific situation of osteopenic women over the age of 65," McLean said. Osteopenia describes a lower than normal bone density, which is not as severe as osteoporosis.
Compared with the 2008 guidelines, the new advisory also makes greater distinctions between men and women, specifically by advising doctors to offer only bisphosphonates, and no other drugs such as denosumab, to men with osteoporosis to reduce their risk of vertebral fracture.
Finally, McLean suggests that physicians read the new guidelines closely, since "every specific word was chosen carefully." They include some fairly general statements, But "very specific nuanced limitations" are indicated in other cases, he noted, and these easily get lost in media accounts.
One expert wants more
Dr. Chris Recknor, a scientist at the Center for Advance Research and Education, believes the guidelines are good and "very well-thought-out." The committee had a "very difficult task," he says, in trying to balance what is simplest to present to doctors without overloading them versus what's right for the patients -- and then to trying to standardize all of that.
That said, Recknor would have preferred that the committee advise physicians on which functional tests are best to assess a patient's fracture risk. Though the committee says that it's helpful to provide counseling on reducing the risk of falls, "there's really no direction on what to do."
"Will the guidelines change how many people are treated? Probably not," said Recknor, who had a large osteoporosis clinic in North Georgia for about 20 years before turning his focus to research.
The problem is not the guidelines, he says, but "how things have progressed in health care" where doctors are just "checking a list."
Based on Medicare guidelines, he explains, older patients come in for annual wellness visits during which their physicians work through questionnaires and document the results in a text note. Yet despite testing for the risk of falls and possible bone fractures, most doctors do not follow up by prescribing medicines or therapies for patients who do not pass these tests.
"We're paying a lot of extra money for physicians to produce a text note ... but then has no action taken upon it," Recknor said.
"What's difficult is, there are so many different recommendations for physicians. It's very confusing," he said.
In an editorial accompanying the new guidelines, Dr. Eric S. Orwoll of Oregon Health and Science University also noted that they are "but one of several that exist," with both the Endocrine Society
and the National Osteoporosis Foundation
issuing their own clinical practice guidelines within the past few years.
Recknor also noted that physicians "only have a very short time period with the patient to decide or not to decide to give them tests and then to give them medication."
Years ago, most patients didn't understand the importance of bone density tests, he said, but they've now become commonplace.
Recknor is frustrated. "I wish we were doing a better job with these (osteoporosis) patients in general, but we're not."
He said that he's hopeful regarding the development of new medications to increase muscle strength -- "things are going to change dramatically in how we do osteoporosis" -- but that there is one factor doctors simply cannot control.
"Patients will fool you," Recknor said.
If you ask a patient how they're doing, many will tell you they're doing fine even when they are not, he said. "Half of them, honestly, they don't want to tell you, because they're afraid if they're not doing good by themselves, you'll put them in a nursing home or something."