Amgen announced top-line data from a primary analysis conducted in a Phase 3 study evaluating the safety and efficacy of denosumab (Prolia®, Amgen) vs risedronate in patients receiving glucocorticoid treatment.
The GIOP study (glucocorticoid-induced osteoporosis, ClinicalTrials.gov Identifier: NCT01575873) was a 24-month, international, multicenter, randomized, double-blind, double-blind, active-controlled trial (n=795) that met all primary and secondary endpoints at 12 months. The study evaluated effects of denosumab 60mg subcutaneously (SC) every 6 months as compared oral risedronate 5mg daily with regard to spine and hip bone mineral density (BMD).
The primary endpoint was the percent change from baseline in lumbar spine BMD at 12 months assessing non-inferiority; secondary endpoints included the percent change from baseline in lumbar spine and total hip BMD assessing superiority.
Compared to risedronate, patients treated with denosumab and receiving continuing glucocorticoid therapy for 12 months had significantly greater gains in BMD at the lumbar spine (4.4% vs. 2.3%) and total hip (2.1% vs. 0.6%), respectively.
In patients newly initiating glucocorticoid therapy, treatment with denosumab resulted in greater BMD increases vs. risedronate, both at the lumbar spine (3.8% vs. 0.8%) and total hip (1.7% vs. 0.2%), respectively. Rates of adverse events and serious adverse events were similar across treatment arms and consistent with the known safety profile of denosumab.
Denosumab, a RANKL inhibitor, is approved for use in postmenopausal women with osteoporosis: at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other therapy; to reduce incidence of vertebral, nonvertebral, and hip fractures; to increase bone mass in men with osteoporosis at high risk for fracture; to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; to reduce incidence of vertebral fractures; and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
Additional analysis of the results is ongoing and the study will remain double-blinded for an additional 12 months (total of 24 months).
Summary and Clinical Applicability
Denosumab treatment led to significant increases in BMD at the lumbar spine and total hip at 12 months as compared to risedronate, both in patients receiving continuing glucocorticoid therapy and those just starting glucocorticoid therapy.
Limitations and Disclosures
The NCT01575873 clinical trial was funded by Amgen, manufacturer of denosumab.
Amgen Announces Positive Top-Line Results From Phase 3 Study Of Prolia® (Denosumab) In Patients Receiving Glucocorticoid Therapy [press release]. Thousand Oaks, CA; Amgen. Accessed August 29, 2016.
This article originally appeared on MPR