FDA Approves Teriparatide Injection for the Treatment of Glucocorticoid-Induced Osteoporosis

Yael Waknine

July 24, 2009

July 24, 2009 — The US Food and Drug Administration (FDA) has approved an expanded indication for teriparatide (rDNA origin) injection (Forteo, Eli Lilly and Company, Inc) for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy (≥5 mg/day of prednisone). Patients in this category include those with a history of osteoporotic fracture, those with multiple risk factors for fracture, and patients who have failed or are intolerant to other available treatments for osteoporosis.

According to a company news release, glucocorticoid medications are used by up to 3% of adults aged 50 years and older, and those who receive chronic therapy are at 50% risk for eventually having an osteoporotic fracture. In contrast with antiresorptives (eg, alendronate), teriparatide exerts its effect by stimulating bone production, thereby countering glucocorticoid-related decreases.

"Until now, physicians and patients had only one class of approved therapy for the treatment of glucocorticoid-induced osteoporosis," said Kenneth G. Saag, MD, MSc, professor of medicine and epidemiology at the University of Alabama in Birmingham. "The approval of teriparatide for this new indication offers healthcare providers and patients a new treatment option that effectively increases bone mineral density in a different way than anti-resorptives."

The FDA's decision was based on data from a randomized, double-blind, active-controlled clinical trial of 428 patients with glucocorticoid-induced osteoporosis. Results at 18 months demonstrated that teriparatide therapy yielded significant improvements from baseline in terms of bone mineral density at the lumbar spine (7.2%), total hip (3.6%), and femoral neck (3.7%; P < .001 for all).

Adverse events most commonly reported in the study included nausea (14%), gastritis (7%), pneumonia (6%), dyspnea (6%), insomnia (5%), anxiety (4%), and herpes zoster (3%).

Because patients with glucocorticoid-induced osteoporosis may be younger than those taking teriparatide for previously approved indications, safety labeling changes emphasize warnings against its use in pediatric patients and young adults with open epiphyses. A voluntary patient registry is also being implemented to obtain further information regarding the risk for osteosarcoma in teriparatide-treated patients.

Teriparatide previously was approved for second-line treatment of postmenopausal osteoporosis at high risk for fracture and to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture.


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