Recommendations on use of the new dual-action anabolic agent romosozumab (Evenity, Amgen)and how to safely transition between osteoporosis agents are two of the issues addressed in the latest clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis from the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE).
"This guideline is a practical tool for endocrinologists, physicians in general, regulatory bodies, health-related organizations, and interested laypersons regarding the diagnosis, evaluation, and treatment of postmenopausal osteoporosis," the authors say.
The guidelines focus on 12 key clinical questions related to postmenopausal osteoporosis, with 52 specific recommendations, each graded according to the level of evidence.
They also include a treatment algorithm to help guide choice of therapy.
Among key updates is an emphasis on the role of the Fracture Risk Assessment Tool (FRAX) in the diagnosis of osteoporosis in patients with osteopenia.
While patients have traditionally been diagnosed with osteoporosis based on the presence of low bone mineral density (BMD) in the absence of fracture, the updated guidelines indicate that osteoporosis may be diagnosed in patients with osteopenia and an increased fracture risk using FRAX.
"The use of FRAX and osteopenia to diagnosis osteoporosis was first proposed by the National Bone Health Alliance years ago, and in the 2016 guideline, we agreed with it," Pauline M. Camacho, MD, co-chair of the guidelines task force, told Medscape Medical News.
"We reiterate in the 2020 guideline that we feel this is a valid diagnostic criteria," said Camacho, professor of medicine and director of the Osteoporosis and Metabolic Bone Disease Center, Loyola University, in Maywood, Illinois.
"It makes sense because when the thresholds are met by FRAX in patients with osteopenia, treatment is recommended. Therefore, why would they not fulfill treatment criteria for diagnosing osteoporosis?"
An increased risk of fracture based on a FRAX score may also be used to determine pharmacologic therapy, as can other traditional factors such as a low T-score or a fragility fracture, the guidelines state.
Another key update is the clarification of the risk stratification of patients who are high risk versus very high risk, which is key in determining the initial choice of agents and duration of therapy.
Specifically, patients should be consideredat a very high fracture risk if they have the following criteria: a recent fracture (eg, within the past 12 months), fractures while on approved osteoporosis therapy, multiple fractures, fractures while on drugs causing skeletal harm (eg, long-term glucocorticoids), very low T-score (eg, less than 3.0), a high risk for falls or history of injurious falls, and a very high fracture probability by FRAX (eg, major osteoporosis fracture > 30%, hip fracture > 4.5%) or other validated fracture risk algorithm.
Meanwhile, patients should be considered at high risk if they have been diagnosed with osteoporosis but do not meet the criteria for very high fracture risk.
Another important update provides information on the role of one of the newest osteoporosis agents on the market, the anabolic drug romosozumab, a monoclonal antibody directed against sclerostin.
The drug's approval by the US Food and Drug Administration (FDA) in 2019 for postmenopausal women at high risk of fracture was based on two large trials that showed dramatic increases in bone density through modeling as well as remodeling.
Those studies specifically showed significant reductions in radiographic vertebral fractures with romosozumab compared to placebo and alendronate.
Camacho noted that romosozumab "will likely be for the very high risk group and those who have maxed out on teriparatide or abaloparatide."
Romosozumab can safely be used in patients with prior radiation exposure, the guidelines note.
Importantly, due to reports of a higher risk of serious cardiovascular events with romosozumab compared to alendronate, romosozumab comes with a black box warning that it should not be used in patients at high risk for cardiovascular events or who have had a recent myocardial infarction or stroke.
"Unfortunately, the very high risk group is often the older patients,"Camacho notes.
"The drug should not be given if there is a history of myocardial infarction or stroke in the past year," she emphasized. "Clinical judgement is needed to decide who is at risk for cardiovascular complications."
Notably, teriparatide and abaloparatide have black box warnings of their own regardingrisk for osteosarcoma.
Reflecting the evolving data on osteoporosis drug holidays, the guidelines also address the issue and the clinical challenges of switching therapies.
"In 2016, we said drug holidays are not recommended, and the treatment can be continued indefinitely, [however] in 2020, we felt that if some patients are no longer high risk, they can be transitioned off the drug," Camacho said.
For teriparatide and abaloparatide, the FDA recommends treatment be limited to no more than 2 years, and for romosozumab, 1 year.
The updated guidelines recommend that upon discontinuation of an anabolic agent (eg, abaloparatide, romosozumab, or teriparatide), a switch to therapy with an antiresorptive agent, such as denosumab or bisphosphonates, should be implemented to prevent loss of BMD and fracture efficacy.
Discontinuation of denosumab, however, can have notably negative effects. Clinical trials show rapid decreases in BMD when denosumab treatment is stopped after 2 or 8 years, as well as rapid loss of protection from vertebral fractures.
Therefore, if denosumab is going to be discontinued, there should be a proper transition to an antiresorptive agent for a limited time, such as one infusion of the bisphosphonate zoledronate.
The authors underscore that in addition to communicating the potential risk and expected benefits of osteoporosis treatments, clinicians should make sure patients fully appreciate the risk of fractures and their consequences, such as pain, disability, loss of independence, and death, when no treatment is given.
"It is incumbent on the clinician to provide this information to each patient in a manner that is fully understood, and it is equally important to learn from the patient about cultural beliefs, previous treatment experiences, fears, and concerns," they write.
And in estimating patients' fracture risk, T-score must be combined with clinical risk factors, particularly advanced age and previous fracture, and clinicians should recognize that the absolute fracture risk is more useful than a risk ratio in developing treatment plans.
"Treatment recommendations may be quite different; an early postmenopausal woman with a T-score of 2.5 has osteoporosis, although fracture risk is much lower than an 80-year-old woman with the same T-score," the authors explain.
Camacho has reported financial relationships with Amgen and Shire. Disclosures for other task force members are detailed in the guidelines.
AACE/ACE Guidelines 2020 Update. Full text
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