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news.Novartis has presented a new six-year data which reinforced the long-term efficacy and safety profile of once-yearly Aclasta (zoledronic acid 5 mg) in postmenopausal women with osteoporosis.
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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.
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.
The primary endpoint of the study was the percentage change in the BMD at the femoral neck at year six vs. year three. Secondary endpoints included evaluation of BMD at other sites, fractures, changes in bone turnover markers and overall safety.
The incidence of adverse events was comparable between groups. There was no long-term effect on renal function or increase in risk of osteonecrosis of the jaw or atrial fibrillation.
Novartis Development global head Trevor Mundel said 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. These long-term data affirm our confidence in the efficacy and safety profile of this medicine.
Approved in more than 90 countries, Aclasta is approved for up to six indications to treat a broad spectrum of patients, from the newly diagnosed to those with more severe forms of osteoporosis.
The indications include treatment of postmenopausal osteoporosis, prevention of postmenopausal osteoporosis, prevention of subsequent fractures after a low-trauma fracture, increase in bone mass in men with osteoporosis, treatment and prevention of glucocorticoid-induced osteoporosis in men and women, and treatment of Paget’s disease of bone in men and women.