This article is more than 5 years old. Information may no longer be current.
Once-yearly drug infusion shows efficacy for treating, preventing glucocorticoid-induced osteoporosis
Click Here to Manage Email Alerts
A once-yearly zoledronic acid infusion increases bone mass significantly better than risedronate in patients with glucocorticoid-induced osteoporosis, according to results of a clinical study presented at the European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis in Istanbul.
David M. Reid and colleagues investigated the efficacy of Aclasta (zoledronic acid 5 mg, Novartis) for preventing or treating glucocorticoid-induced osteoporosis in 833 patients. Specifically, the prevention group included 288 patients and the treatment group included 545 patients, according to a press release from Novartis.
Results demonstrated that a single yearly zoledronic acid infusion significantly increased bone mineral density (BMD) in the lumbar spine. At 12 months follow-up, patients in the treatment group who received zoledronic acid showed an average 4.1% increase in BMD compared to a 2.7% increase among risedronate-treated patients (P=.0001).
Among patients in the prevention group, those who received zoledronic acid had an average 2.6% increase in BMD compared to 0.6% for those who received risedronate (P<.0001), according to the release.
The primary objective of the study was to demonstrate noninferiority of zoledronic acid to risedronate in the percentage of lumbar spine BMD change over 1 year. Secondary endpoints included changes in lumbar spine BMD at 6 months and changes in femoral neck and total hip BMDs at 6 and 12 months.
The most common adverse events associated with treatment with zoledronic acid included transient postdose symptoms such as fever and muscle pain, most of which occurred in the first 3 days after administration and resolved within 3 days.
Novartis is applying to the European Medicines Agency and the U.S. Food and Drug Administration for additional indications for zoledronic acid to treat and prevent glucocorticoid-induced osteoporosis, the release noted.
For more information:
- Reid DM, Devogelaer J-P, Saag K, et al. A single infusion of zoledronic acid 5 mg is significantly more effective than daily oral risedronate 5 mg in increasing bone mineral density of the lumbar spine, hip, femoral neck and trochanter in patients with glucocorticoid-induced osteoporosis. Presented at the European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis. April 9-12, 2008. Istanbul.