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

Updated: Aug 27, 2020
  • Author: Monique Bethel, MD; 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. [156] It decreases bone resorption by inhibiting osteoclast activity. Denosumab was approved by the US Food and Drug Administration in June 2010. It has been studied in cancer patients, patients with postmenopausal osteoporosis, and men with low bone mineral density (BMD). [172, 173, 174]  The approved dosage is 60 mg given subcutaneously every 6 months.

Denosumab may be considered in certain patients with renal insufficiency, as impaired renal function does not significantly affect the metabolism or excretion of the drug. [175]

In May 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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