Friday, 22 Jun 2018

You are here

FDA Approves Denosumab for Glucocorticoid-Induced Osteoporosis

Amgen announced that the U.S. 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).  This also follows an EU CHMP recommendation last month calling for the approval of denosumab for use in GIOP.

"Patients on long-term systemic glucocorticoid medications can experience a rapid reduction in bone mineral density within a few months of beginning treatment1," said study lead Kenneth F. Saag, M.D., M.Sc., Professor of Medicine at the University of Alabama at Birmingham School of Medicine. "With this approval, patients who receive treatment with glucocorticoids now have a new option to help improve their bone mineral density."

The approval is supported by the 12-month primary analysis of a 24-month Phase 3, randomized, double-blind, double-dummy, active-controlled study evaluating the safety and efficacy of Prolia 60 mg subcutaneously every six months compared with oral risedronate 5 mg once daily in 795 patients receiving glucocorticoid treatment, greater than or equal to 7.5 mg/day oral prednisone (or equivalent).

The study included two patient groups: a glucocorticoid-initiating subpopulation, receiving treatment for less than three months prior to study enrollment and planning to continue treatment for a total of at least six months, and a glucocorticoid-continuing subpopulation, receiving treatment for greater than or equal to three months prior to study enrollment and planning to continue treatment for a total of at least six months.

Study results showed that in the glucocorticoid-continuing subpopulation, Prolia demonstrated a significantly greater increase in lumbar spine BMD compared to risedronate at one year (3.8 percent versus 0.8 percent, respectively) with a treatment difference of 2.9 percent (p<0.001). Similarly, in the glucocorticoid-initiating subpopulation, denosumab demonstrated a significantly greater increase in lumbar spine BMD compared to risedronate at one year (4.4 percent versus 2.3 percent, respectively) with a treatment difference of 2.2 percent (p<0.001). Consistent effects on lumbar spine BMD were observed regardless of gender; race; geographic region; menopausal status; and baseline age, lumbar spine BMD T-score, and glucocorticoid dose within each subpopulation.

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

Update on Osteoporosis

This session was an update on the management of osteoporosis given by Professor Christian Roux from France.

He emphasised the use of composite risk score like the FRAX. He highlighted that the risk of vertebral fracture is increased by both the recency and severity of previous vertebral fracture. So it is important that those with vertebral fractures are followed up and treated appropriately to prevent subsequent fractures.

Restless Sleep and Inactivity Intertwined in OA

Adults with osteoarthritis (OA) of the knee who frequently experienced restless sleep were less likely to engage in potentially beneficial moderate-to-vigorous physical activity, analysis of data from the Osteoarthritis Initiative found.

Bisphosphonate Drug Holidays May Result in Fractures

A report in Endocrine Practice shows that drug holidays from bisphosphonates results in a 15% risk of fractures.  (Citation source: http://bit.ly/2FHbFwp)

USPSTF Recommendations on Vitamin D, Calcium Supplementation to Prevent Fractures

The U.S. Preventive Services Task Force (USPSTF) concludes current scientific evidence is insufficient regarding the use of vitamin D and calcium, alone or in combination, to prevent fractures in men and premenopausal women. The USPSTF recommends against daily supplementation with 400 IU or less of vitamin D and 1,000 mg or less of calcium to prevent fractures in postmenopausal women. Current scientific evidence is insufficient regarding the use of vitamin D and calcium at doses greater than 400 IU of vitamin D and greater than 1,000 mg of calcium in postmenopausal women.

Obesity Surgery Tames Knee OA Pain

Laparoscopic gastric band (LAGB) surgery was associated with significant decreases in knee pain from osteoarthritis (OA), with the greatest improvements seen among those whose body mass index (BMI) had the greatest decreases and among younger patients, researchers reported.