New Guidelines Address Osteoporosis Treatment Postmenopause

NEW ORLEANS — New Endocrine Society guidelines on the pharmacologic treatment of osteoporosis in postmenopausal women aim to encourage clinicians to boost rates of screening and treatment for the condition.

The document, entitled "Pharmacologic Management of Osteoporosis in Postmenopausal Women," was presented March 25 here at ENDO 2019: The Endocrine Society Annual Meeting and simultaneously published online in the Journal of Clinical Endocrinology & Metabolism along with other online resources. The document is cosponsored by the European Society of Endocrinology.

Writing panel chair Clifford J. Rosen, MD, director of the Center for Clinical and Translational Research at the Maine Medical Research Institute, Scarborough, summarized the guideline's key points at a press briefing.

"We need to be aggressive about treating individuals who have had a previous fracture," he told Medscape Medical News.

As a start, lifestyle and nutritional optimization for bone health — especially calcium and vitamin D — are recommended for all postmenopausal women, along with an assessment of 10-year fracture risk according to country-specific guidelines.

As in the past, bisphosphonates and denosumab are still advised as first-line therapies. But the Endocrine Society now recommends anabolic treatments — teriparatide or abaloparatide (Tymlos, Radius Health) — as first-line therapy for patients with very severe osteoporosis, multiple fractures, and/or very low bone density.

That new recommendation, Rosen said, "means that we get intervention early, as the effects are quicker than they are with bisphosphonates."

For women who have been on bisphosphonates for 3 to 5 years, fracture risk should be assessed.

Following reassessment, women who have a low-to-moderate risk of fracture should be prescribed a "bisphosphonate holiday."

All women taking osteoporosis therapies — except anabolics — should consume calcium and vitamin D in their diet or by taking supplements.

Monitoring of bone mineral density (BMD) for high-risk patients with low BMD should take place every 1 to 3 years, the guidelines say.

Have the Risks of Osteoporosis Treatments Been Overstated?

Asked during the briefing about the risks associated with some of these osteoporosis treatments, Rosen acknowledged the particular concern about atypical femoral fractures that have been linked to bisphosphonates, noting that patients often ask why they should take a drug to prevent fractures that might cause a fracture.

"We are very concerned about that. Some of the recent data suggest that the risk for atypical femoral fractures with bisphosphonates remains quite low," he said.

But he also noted that certain factors do increase that risk, especially longer duration of therapy. "That's one of the reasons we've advocated a drug holiday in many individuals who have been successfully treated for up to 3 years with a bisphosphonate." The other adverse events, including osteonecrosis of the jaw, are less frequent, he noted.

"The femoral fracture has gotten the most attention and has been the most disconcerting to individuals," Rosen added. "From a physician standpoint, it's hard because you have to spend the time to discuss absolute risk and relative risk differences for an individual patient. And you also have to receive signals from the individual who you want to treat as to what their perception of risk is and how fearful they are. That takes time, and in our healthcare system that's difficult, so many providers are reluctant to treat."

Because of that, he said, "the number of prescriptions has gone way down for anti-osteoporosis therapies, as has the number of screening DEXAs. That's one of the reasons we're concerned, since that's a very good risk predictor for predicting 10-year fracture risk."

At the same time DEXA use has dropped — in part because of declines in reimbursement — hip fracture rates have been leveling off, whereas they had been declining for many years.

"We think it's because we're not treating enough people. We're starting them on medication but 70% are not on therapy within a year after initiation. We think that's due to worry about fractures. I think sometimes it's a lack of communication from providers about the importance of staying on therapy...It's a real dilemma for us. It's important to treat."

Comparison to the ACPs' 2017 Guidelines

In the introduction to the guidelines, the Endocrine Society panel points out some of the differences between these new guidelines and those issued by the American College of Physicians (ACP) in 2017 for treatment of low BMD or osteoporosis in women and men.

"Certain recommendations in those guidelines have raised new questions and generated much discussion, especially with regard to the duration of therapy and monitoring," the Endocrine Society document notes.

For instance, the ACP recommends that women with osteoporosis should be treated with drug therapy for 5 years and recommends against monitoring their BMD during that period. No differentiation is made for duration of therapy between bisphosphonates and denosumab, despite the different pharmacokinetic profiles of the two classes.

The ACP guidelines also don't include recommendations regarding use of abaloparatide, which was approved by the US Food and Drug Administration just prior to the release of those guidelines. And they don't advise use of teriparatide for severely affected patients.

Asked to comment, ACP guideline coauthor Robert McLean, MD, a practicing rheumatologist in New Haven, Connecticut, and ACP president-elect, told Medscape Medical News: "The ACP guidelines tend to give broader recommendations with the full recognition that clinical recommendations may not apply to every patient or all clinical situations."

Moreover, McLean said, "The ACP guideline process is very strictly evidence-based when it decides what recommendations it can make and what recommendations it cannot make. This clearly leads to some limitations, because there are simply not adequately designed trials to answer the clinical questions that arise in some specific patient situations."

He noted that the Endocrine Society guidelines are more detailed than the ACP's in certain sections. “I do think the ACP guidelines are more broad and general, based on the evidence-based process we follow.”

Overall, McLean said, the important issue regarding guidelines is "what information can be understood by and explained to our patients by any clinician to make shared decision-making conversations most helpful."

Rosen and McLean have reported no relevant financial relationships.

ENDO 2019. Presented March 25, 2019.

Eastell R, et al. J Clin Endocrinol Metab. 2019;104:1-28. Full text

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