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Up to 50% of patients receiving long-term glucocorticoid therapy are atincreased risk of fracture due to osteoporosis(2). Glucocorticoid-inducedosteoporosis (GIO) is the most prevalent form of "secondary osteoporosis,"which is characterized by low bone mass that results directly from specificdiseases or medications(1).
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Results of a clinical study in 833 men and women were presented today atthe European Congress on Clinical and Economic Aspects of Osteoporosis andOsteoarthritis (ECCEO) in Istanbul, Turkey(3).
"Recognizing and treating GIO is an important need, as glucocorticoidtherapy is widely used and presents an ongoing challenge for physicians," saidProfessor David M. Reid, Head of the Division of Applied Medicine atUniversity of Aberdeen, UK. "The significant efficacy of this once-yearlytreatment, offering year-long bone protection, will provide a valuabletreatment option for healthcare professionals treating and managingosteoporosis induced by glucocorticoids."
The trial investigated both prevention (n=288) and treatment (n=545) ofGIO in patients. Results demonstrated that a single yearly infusion ofReclast significantly increased bone mineral density (BMD) in the lumbar spineat 12 months compared to risedronate in both the treatment group (Reclast4.1%, risedronate 2.7%; P=0.0001) and prevention group (Reclast 2.6%,risedronate 0.6%; P<0.0001)(3).
Risedronate is one of the established treatments for GIO(4). LikeReclast, risedronate is a member of the bisphosphonate class of drugs(4).Risedronate is taken in the form of a daily pill for the indication of GIO,whereas Reclast was studied as a once-yearly 15-minute infusion(4,5).
Novartis is applying for an indication with the U.S. Food and DrugAdministration (FDA) for the treatment and prevention of GIO. Reclast isalready approved for the treatment of postmenopausal osteoporosis and for thetreatment of Paget's disease of bone in men and women, the second most commonmetabolic bone disorder(1).
"These new data reinforce the efficacy of this novel once-yearly treatmentand confirm Reclast's ability to increase bone mineral density significantlyin different populations," said Trevor Mundel, MD, Head of Global DevelopmentFunctions at Novartis Pharma AG.
The primary objective of the GIO study was to demonstrate non-inferiorityof Reclast to risedronate in percentage change in lumbar spine BMD frombaseline at 12 months. Secondary endpoints included percentage change inlumbar spine BMD at six months, and in the BMD of femoral neck and total hipat six and 12 months(3).
Results from the study confirm the demonstrated safety profile of Reclast.The most common adverse events associated with Reclast were transientpost-infusion symptoms such as fever and muscle pain. The majority of thesesymptoms occurred in the first three days after Reclast administration andresolved within three days. Post-infusion symptoms can be reduced by takingacetaminophen or ibuprofen shortly after the Reclast infusion(3).
Analysis of key safety parameters, including osteonecrosis of the jaw,atrial fibrillation, renal impairment and delayed fracture healing, foundReclast was comparable to risedronate(6).
The active ingredient in Reclast is zoledronic acid, which is alsoavailable in a different dosage under the brand name Zometa(R) (zoledronicacid) Injection 4 mg for use in certain oncology indications(7).
Patients should not take Reclast if they're on Zometa as it contains t
