What is the role of denosumab (Prolia) in the treatment of osteoporosis?

Updated: Jan 20, 2021
  • Author: Rachel Elizabeth Whitaker Elam, MD, MSc; Chief Editor: Herbert S Diamond, MD  more...
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Denosumab (Prolia) is a humanized monoclonal antibody directed against the receptor activator of the nuclear factor–kappa B ligand (RANKL), which is a key mediator of the resorptive phase of bone remodeling. [181] Denosumab decreases bone resorption by inhibiting osteoclast activity. Denosumab was approved by the FDA in 2010. It has shown benefit in cancer patients, patients with postmenopausal osteoporosis, and men with low BMD. [199, 200, 201]  The approved dosage is 60 mg given subcutaneously every 6 months.

Denosumab may be considered in certain patients with renal insufficiency, as impaired kidney function does not significantly affect the metabolism or excretion of the drug. [202]

In 2018, denosumab was approved for treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 6 months. Patients are considered at high risk of fracture if they have a history of osteoporotic fracture, multiple risk factors for fracture, or failed or cannot tolerate other available osteoporosis therapy.

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