Romosozumab Added to Osteoporosis Drug Therapy Guideline

Medications are an effective way to treat osteoporosis, a condition characterized by weakened bones and bone loss. Several classes of osteoporosis medications are available today, and they work in unique ways to strengthen your bones to help prevent spinal fractures.

osteoporosis is loss of bone density and strengthPostmenopausal women are much more likely than men to develop osteoporosis. Photo Source: iStock.com.

With many drug treatments on the market, it’s important that spine specialists and other clinicians have the current, evidence-based treatment information to provide the best possible care to their patients. To that end, The Endocrine Society updated its 2019 Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Clinical Practice Guideline with a new drug option for osteoporosis.

The 2020 update to the Endocrine Society’s Guideline focuses on the addition of the drug romosozumab (brand name, Evenity), which was recently approved by the U.S. Food and Drug Administration (FDA) and other global agencies to treat osteoporosis.

This Guideline focuses on medication treatments for postmenopausal women with osteoporosis. Women are much more likely than men to develop osteoporosis; in fact, 80% of osteoporosis cases affect women.1

More About Romosozumab: The Latest Update to the Guideline

Romosozumab is a drug that strengthens bone mineral density (BMD) by blocking a protein called sclerostin from limiting the formation of new bone.

After reviewing high-quality evidence supporting its effectiveness for osteoporosis, along with its recent approval by global health agencies, the authors of the Guideline added romosozumab as a possible treatment option that providers should consider.

Below is an overview of the latest Guideline update regarding romosozumab:

  • Who should take romosozumab? Postmenopausal women who have low BMD and are at a heightened risk for fracture may take romosozumab as a first-line therapy for osteoporosis (ie, it may be one of the first treatments your doctor prescribes to improve your bone health).
  • Treatment guidelines: Romosozumab may be used for up to 1 year to help reduce fracture risk. The medication is delivered on a monthly basis by injection.
  • Notable side effects: The Guideline authors recommend that women at high risk for heart disease or stroke avoid romosozumab, as more research needs to shed light on the potentially serious heart-related side effects.
  • Maintaining bone health after treatment: After completing a year of romosozumab therapy, the Guideline authors recommend women maintain their BMD and reduce their fracture risk by taking an anti-resorptive therapy, such as a bisphosphonate (eg, alendronate or ibandronate).

Other Osteoporosis Drug Treatment Recommendations in the Guideline

The Endocrine Society’s Guideline for osteoporosis drug treatment contains several other drug classes that treat osteoporosis and prevent fracture in postmenopausal women.

For women who have already experienced a spinal fracture or another bone, these therapies are particularly important. If you’ve suffered a fracture, you’re at a higher risk of having another. These drug treatments are often effective enough to strengthen your bones and prevent fracture, even if you have severe osteoporosis.

Bisphosphonates

  • A class of first-line drugs for osteoporosis that increases BMD in the spine and hips, reducing fracture risk.
  • Examples include: alendronate, ibandronate, risedronate, and zoledronic acid
  • Fracture risk assessed in people taking bisphosphonates every 3 to 5 years; if risk lowers from high to low-to-moderate risk, consider whether patient should take a “bisphosphonate holiday,” which is an up to 5-year break from bisphosphonate use. During the holiday, BMD should be tested at 2- to 4-year intervals.

Denosumab

  • Considered an “alternative” first-line osteoporosis treatment
  • Given via injection every 6 months; the effects of the drug do not extend past 6 months, so maintaining a strict every-6-month schedule is essential.

Teriparatide and abaloparatide

  • Teriparatide and abaloparatide are parathyroid hormone (PTH) and PTH-related protein analogs that reduce fracture risk.
  • Patients inject the medication daily into their abdomen or thigh.
  • The guideline authors recommended taking teriparatide or abaloparatide for up to 2 years. Once a course of treatment is complete, patients should continue taking a bisphosphonate to maintain bone health.

Selective estrogen receptor modulators

  • These therapies work by affecting estrogen receptors. They increase BMD, reduce spinal fracture risk, and reduce breast cancer risk.
  • Recommended for women who have a high risk of breast cancer, cannot take bisphosphonates or denosumab, and have a low risk of deep vein thrombosis (DVT)
  • Examples include: raloxifene and bazedoxifene

Menopausal hormone therapy

  • Estrogen-only hormone therapy is recommended for women who are under 60 years old or less than 10 years into menopause; have a low risk of DVT; cannot take bisphosphonates or denosumab; and have never had stroke, heart disease, and breast cancer.

Calcitonin

  • Calcitonin is a prescription nasal spray that slows bone loss.
  • Recommended only for postmenopausal women at high risk for fracture who cannot take other osteoporosis drug treatments.  

Calcium and vitamin D

  • Daily calcium and vitamin D from supplements and diet are recommended both for people who can tolerate osteoporosis medications and for those who are unable to take medication.

Working With Your Doctor on Finding the Right Drug Treatment

You have many options to treat your osteoporosis, and this Guideline will help your doctor recommend the safest, most effective drug therapies to strengthen your bones and prevent spinal fracture.

Know that all drugs and medications bear side effects. Although romosozumab may cause heart-related complications, the authors of this guideline note that the injection is generally well tolerated. You should talk your doctor about the side effects of every treatment in your regimen. It’s also important to complement your osteoporosis medication therapies with healthy lifestyle habits that prevent bone loss. Eating a diet rich in calcium and vitamin D and staying active are the foundations of a strong osteoporosis prevention plan.

You may read the Endocrine Society's full guideline here:
Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Guideline Update

Updated on: 03/06/20
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How to Start Your Osteoporosis Prevention Plan Today

Osteoporosis is a preventable bone disease. Even if you have been diagnosed with osteoporosis, there are steps you can take with your doctor's help to help manage low bone mineral density and prevent spinal fracture.
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