Novartis announced that new six-year data reinforce the long-term efficacy and safety profile of once-yearly Aclasta (zoledronic acid 5 mg) in postmenopausal women with osteoporosis. The study of more than 1,200 women was presented at the annual meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, Canada.
The study showed that Aclasta preserved bone mass in postmenopausal osteoporotic patients who received annual infusions for six years. In patients who stopped Aclasta treatment after three years, the bone mineral density (BMD) decreased but remained well above the levels measured at the beginning of the study (difference between the two groups at six years: 1.04%, p=0.0009).
Patients who stayed on Aclasta therapy for six years reduced their risk of new morphometric spine fractures by 52%, compared to those who stopped treatment at three years (p=0.04), the study also showed. Morphometric fractures can occur unaccompanied by pain and therefore may not be diagnosed and treated. Over time patients can experience these fractures in the form of back pain, loss of height, or stooped posture.
"These new findings show that continued treatment with zoledronic acid for six years continues to maintain bone mass and reduces vertebral fractures risk with no change to its favourable safety profile compared to discontinuation of treatment after three years," said Dennis Black, the study's lead author and Professor of Epidemiology and Biostatistics at the University of California, San Francisco. "These new long-term data reconfirm Aclasta as an important therapeutic option for doctors when considering an osteoporosis medicine for their patients."
In both study groups, the bone markers were maintained over six years within the normal premenopausal range. In patients who discontinued Aclasta after three years, there was no evidence of accelerated bone loss. This builds upon existing data from extensive clinical studies and confirms that Aclasta helps preserve bone turnover, the balanced process by which the bone is constantly renewed and remodelled throughout adult life.
"Aclasta is highly effective at protecting patients against osteoporotic fractures for a long period of time and its once-yearly dosing represents an important improvement for patients and doctors in terms of compliance for an entire year," said Trevor Mundel, Global head of Development at Novartis AG. "These long-term data affirm our confidence in the efficacy and safety profile of this medicine."