Pharmacological Management of Osteoporosis in Postmenopausal Women: Endocrine Society Guideline

The Endocrine Society today announced an update to its osteoporosis Clinical Practice Guideline to include recommendations for romosozumab, a new medication that was approved last year to treat postmenopausal women at high risk of fracture. It is an update of the 2019 Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Clinical Practice Guideline for the pharmacological management of osteoporosis in postmenopausal women using romosozumab.

The U.S. Food and Drug Administration approved romosozumab in April 2019, a month after the guideline was published.

"We felt it was important to update our guideline to reflect the newest, most effective medication options available for patients with osteoporosis," said Clifford J. Rosen, M.D., director, Center for Clinical and Translational Research at the Maine Medical Center Research Institute in Scarborough. Rosen chaired the writing committee that developed the guideline.

"Romosozumab offers promising results for postmenopausal women with severe osteoporosis or who have a history of fractures," Rosen said. "It does, however, come with a risk of heart disease, so clinicians need to be careful when selecting patients for this therapy."

New recommendations from the guideline include:

1. We recommend treating postmenopausal women at high risk of fractures, especially those who have experienced a recent fracture, with pharmacological therapies, as the benefits outweigh the risks. 
2. Postmenopausal women who have a very high risk of fracture can be treated with romosozumab for up to one year, but women with a high risk of heart disease and stroke should not be considered for treatment with romosozumab, pending further studies.
3. Women who have been on romosozumab for a year should be treated with antiresorptive osteoporosis therapies to protect their bone health.
4. In postmenopausal women with osteoporosis at high risk of fracture and with the patient characteristics below, we recommend raloxifene or bazedoxifene to reduce the risk of vertebral fractures. Patient characteristics: With a low risk of deep vein thrombosis and for whom bisphosphonates or denosumab are not appropriate or with a high risk of breast cancer. 
5. In postmenopausal women at high risk of fracture and with the patient characteristics below, we suggest menopausal hormone therapy, using estrogen-only therapy in women with hysterectomy, to prevent all types of fractures.  Patient characteristics: Under 60 years of age or < 10 years past menopause; at low risk of deep vein thrombosis; those in whom bisphosphonates or denosumab are not appropriate; with bothersome vasomotor symptoms; with additional climacteric symptoms; without contraindications; without prior myocardial infarction or stroke; without breast cancer; willing to take menopausal hormone therapy.
6. In postmenopausal women with osteoporosis at high risk of fracture and with the patient characteristics below, we suggest tibolone to prevent vertebral and nonvertebral fractures.   Patient characteristics: Under 60 years of age or < 10 years past menopause; with a low risk of deep vein thrombosis; those in whom bisphosphonates or denosumab are not appropriate; with bothersome vasomotor symptoms; with additional climacteric symptoms; without contraindications; without prior myocardial infarction or stroke or high risk for cardiovascular disease; without breast cancer; willing to take tibolone.  Technical remark: Tibolone is not available in the United States or Canada
7. In postmenopausal women at high risk of fracture with osteoporosis, we suggest that nasal spray calcitonin be prescribed only in women who cannot tolerate raloxifene, bisphosphonates, estrogen, denosumab, tibolone, abaloparatide, or teriparatide or for whom these therapies are not considered appropriate.
8. In postmenopausal women with low bone mineral density and at high risk of fractures with osteoporosis, we suggest that calcium and vitamin D be used as an adjunct to osteoporosis therapies.
9. In postmenopausal women at high risk of fracture with osteoporosis who cannot tolerate bisphosphonates, estrogen, selective estrogen response modulators, denosumab, tibolone, teriparatide, and abaloparatide, we recommend daily calcium and vitamin D supplementation to prevent hip fractures. 

"Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Guideline Update," was published in the Society's Journal of Clinical Endocrinology & Metabolism, online ahead of print.

For further reference log on to :

 https://doi.org/10.1210/clinem/dgaa048