Osteoporosis guideline update recommends romosozumab for women at high fracture risk
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The Endocrine Society updated its osteoporosis clinical practice guideline to include recommendations for romosozumab, noting that the monthly injection therapy is an “effective option” for postmenopausal women at high risk for fracture, according to a society press release.
In announcing the updated recommendations, the guideline committee also noted that romosozumab (Evenity, Amgen), a humanized monoclonal antibody that targets sclerostin, is not indicated for all postmenopausal women at high fracture risk, stating that women with a history of cardiovascular disease are not candidates for the therapy.
“Romosozumab was only recently approved, and there is a lot of interest in better understanding how to use the drug and why it is important,” Clifford J. Rosen, MD, director of the Center for Clinical and Translational Research at the Maine Medical Center Research Institute in Scarborough, and chair of the guideline writing committee, told Healio. “There was a signal that there might be an increase in CV events with the two trials, but the number of CV events was quite small. One has to take that with a grain of salt and be cautious, because an increased risk for major adverse CV events was there. FDA felt strongly that since this was conducted primarily with postmenopausal women, there should be caution in using this drug in women at high risk for CVD.”
New recommendations from the guideline state that postmenopausal women who have a very high risk for fracture can be treated with romosozumab for up to 1 year; however, women with high risk for CVD and stroke should not be considered for treatment with romosozumab, pending further studies.
Additionally, women treated with romosozumab should be switched to antiresorptive osteoporosis therapies after 1 year to protect bone health, according to the guideline.
The guideline update was published in response to the recent approval of romosozumab by the FDA, the European Medicines Agency, Health Canada and other international agencies, and represents a formal amendment to the Endocrine Society’s 2019 clinical practice guideline on the pharmacological management of postmenopausal osteoporosis. As Healio previously reported, the FDA approval of romosozumab, announced by the agency in April, is indicated for women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who cannot take other osteoporosis therapies or for whom other osteoporosis therapies have failed. The approval includes a boxed warning on its labeling stating that it may increase risks for myocardial infarction, stroke and CV death and should not be taken by patients who experienced a CV event within the previous year.
Romosozumab works by binding and inhibiting the activity of the protein sclerostin and, as a result, has a dual effect on bone, both increasing bone formation and decreasing bone breakdown. One dose of romosozumab consists of two injections, one immediately following the other, given once a month by a health care professional. The bone-forming effect of romosozumab wanes after 12 doses, so more than 12 doses should not be used. If osteoporosis therapy is needed after the 12 doses, patients should begin an osteoporosis treatment that reduces bone breakdown, according to the FDA.
“We will probably never have a drug that builds bone constantly, so this drug builds bone for the for the first 3 or 4 months very rapidly, and then stops the breakdown of old bone,” Rosen said in an interview. “It is a good combination, and we felt that 1 year would give a big enough boost to bone density by about 10% to 15%. Most investigators felt continuing therapy beyond that time would probably not have much impact.” The guideline includes an algorithm designed to guide clinicians in the most appropriate therapeutic choices when discussing clinical decision-making with the patient. – by Regina Schaffer
For more information:
Clifford J. Rosen, MD, can be reached at the Center for Clinical and Translational Research at the Maine Medical Center Research Institute, 81 Research Drive, Scarborough, ME 04074; email: rosenc@mmc.org.
Disclosures: Rosen reports no relevant financial disclosures. Please see the guideline update for all other authors’ relevant financial disclosures.
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