Source/Disclosures
Disclosures: Lewiecki reports he has received consultant fees from Alexion, Amgen, Radius Health, Samsung Bioepis and Sandoz, speaking fees from Alexion and Radius Health, and research support from Amgen, Bindex, Mereo and Radius Health. Please see the guideline for all other authors’ relevant financial disclosures.
May 26, 2020
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Guideline highlights risk stratification in treating postmenopausal osteoporosis

Source/Disclosures
Disclosures: Lewiecki reports he has received consultant fees from Alexion, Amgen, Radius Health, Samsung Bioepis and Sandoz, speaking fees from Alexion and Radius Health, and research support from Amgen, Bindex, Mereo and Radius Health. Please see the guideline for all other authors’ relevant financial disclosures.
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Michael Lewiecki
Michael Lewiecki

A baseline fracture risk should guide the selection of initial osteoporosis therapy for postmenopausal women, and treatment should be continued for as long as the expected benefits outweigh the potential risks, according to an updated guideline from the American Association of Clinical Endocrinologists and the American College of Endocrinology.

The guideline, previously updated in 2016, provides a consensus on how to manage postmenopausal osteoporosis and includes recommendations for diagnosis and a new algorithm for treatment. The guideline was published in Endocrine Practice.

“The new guidelines emphasize the importance of risk stratification in making treatment decisions to reduce fracture risk,” E. Michael Lewiecki, MD,FACE, FACP, director of the New Mexico Clinical Research and Osteoporosis Center and director of Bone Health TeleECHO Clinic at the University of New Mexico Health Sciences Center in Albuquerque, told Healio. “Information about the newest anabolic agent, romosozumab, is included, as well as new concepts on managing the transition from denosumab to other therapeutic agents.”

The updated guideline notes that postmenopausal women with osteoporosis can be stratified according to “high-risk” and “very high-risk” features, which include prior fractures. This stratification drives the choice of initial osteoporosis agent and the duration of therapy.

A baseline fracture risk should guide the selection of initial osteoporosis therapy for postmenopausal women, and treatment should be continued for as long as the expected benefits outweigh the potential risks.
Source: Adobe Stock

New therapy option

The guideline also includes new recommendations for the monoclonal antibody romosozumab (Evenity, Amgen), approved by the FDA in April 2019. Romosozumab is indicated for women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who cannot take other osteoporosis medications or for whom other osteoporosis therapies have failed.

“Pharmacological therapy to reduce fracture risk is indicated for patients at high fracture risk, defined as having a T-score of –2.5 or below, a T-score between –1 and –2.5 with high fracture probability by Fracture Risk Assessment Tool (FRAX; 20% for major osteoporotic fracture or 3% for hip fracture) or a history of fragility fracture of the hip or spine,” Lewiecki said. “Appropriate medications for initial treatment include alendronate, denosumab, risedronate and zoledronate, with consideration of ibandronate and raloxifene when reduction of hip fracture risk is not a priority.”

For postmenopausal women at very high fracture risk, such as those with a recent fracture, multiple fractures, fractures while on treatment, long-term glucocorticoid therapy, high risk of falls or very high fracture probability by FRAX (defined as 30% for major osteoporotic fracture or 4.5% for hip fracture), clinicians should consider initial treatment with abaloparatide (Tymlos, Radius Health), denosumab (Prolia, Amgen), romosozumab, teriparatide (Forteo, Eli Lilly; Bonsity, Alvogen) or zoledronate, Lewiecki said.

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“Patients should be monitored for treatment response and for achievement of an acceptable level of fracture risk,” Lewiecki said.

Treatment with abaloparatide and teriparatide should be limited to 2 years, followed by bisphosphonate or denosumab therapy, according to the guideline. Treatment with romosozumab should be limited to 1 year and followed with a drug intended for long-term use, such as a bisphosphonate or denosumab.

For oral bisphosphonates, clinicians should consider a bisphosphonate holiday after 5 years of treatment if fracture risk is no longer high; treatment should continue for up to 5 more years if fracture risk remains high. For zoledronate, consider a bisphosphonate holiday after 3 years in high-risk patients or until fracture risk is no longer high, and continue for up to 6 years in very high-risk patients, according to the guideline.

Communicating risk

The authors noted that treatment recommendations can vary depending on age; an early postmenopausal woman with a T-score of 2.5 has osteoporosis, although fracture risk is much lower than for a women aged 80 years with the same T-score.

“Effective risk communication imparts to the patient a good understanding of fracture risk with no treatment compared with the balance of benefits and risks with treatment,” the researchers wrote.

“Osteoporosis is a lifelong disease that warrants lifelong attention,” Lewiecki said. “The baseline level of fracture risk should guide the selection of initial therapy and treatment should be continued as long as the expected benefits outweigh the potential risks. Treatment decisions should be individualized according to all available clinical information, including patient preference.” – by Regina Schaffer

For more information:

E. Michael Lewiecki, MD, FACP, FACE, can be reached at the New Mexico Clinical Research & Osteoporosis Center, 300 Oak St. NE, Albuquerque, NM 87106; email: mlewiecki@gmail.com.

Disclosures: Lewiecki reports he has received consultant fees from Alexion, Amgen, Radius Health, Samsung Bioepis and Sandoz, speaking fees from Alexion and Radius Health, and research support from Amgen, Bindex, Mereo and Radius Health. Please see the guideline for all other authors’ relevant financial disclosures.