Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Prolia for GIOP in Men and Women

FirstWord Pharma news release; 2018 May 21

Amgen recently announced that the US Food and Drug Administration (FDA) has approved the use of Prolia (denosumab) for the treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. This approval is based on data from a Phase 3 study which showed patients on glucocorticoid therapy who received Prolia had greater gains in bone mineral density (BMD) compared to those who received active comparator (risedronate). Amgen is headquartered in Thousand Oaks, CA.

Dosage/administration: Pregnancy must be ruled out prior to administration of Prolia. Prolia should be administered by a healthcare professional and the recommended dosage is 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen. Patients should be instructed to take calcium 1,000 mg daily and at least 400 IU vitamin D daily.

Adverse reactions: With GIOP, the most common adverse reactions (> 3% and more common than active-control group) were back pain, hypertension, bronchitis, and headache.


FDA approves Prolia (denosumab) for glucocorticoid-induced osteoporosis. [news release]. Thousand Oaks, CA: Amgen. May 21, 2018. Accessed May 31, 2018.

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FDA Approves Consensi for Osteoarthritis Pain, FirstWord Pharma news release; 2018 May 31

FDA Approves Prolia for GIOP in Men and Women, FirstWord Pharma news release; 2018 May 21

FDA Approves Xeljanz/Xeljanz XR for Adult PsA, Pfizer news release; 2017 Dec 14

FDA Approves New Pfizer Biosimilar Ixifi, Pfizer news release; 2017 Dec 13