Data show osteoporosis drug preserves bone mass, provides fracture protection

MANILA, Philippines - Novartis announced recently that new six-year data reinforce the long-term efficacy and safety profile of once-yearly 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 in Toronto, Canada.

The study showed that zoledronic acid 5 mg preserved bone mass in postmenopausal osteoporotic patients who received annual infusions for six years.

In patients who stopped zoledronic acid 5 mg 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 percent, p=0.0009).

Patients who stayed on zoledronic acid 5 mg therapy for six years reduced their risk of new morphometric spine fractures by 52 percent, 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 5 mg for six years continues to maintain bone mass and reduces vertebral fractures risk with no change to its favorable safety profile compared to discontinuation of treatment after three years,” said Dennis Black, Ph.D., the study’s lead author and professor of epidemiology and biostatistics at the University of California, San Francisco.

“These new long-term data reconfirm zoledronic acid 5 mg as an important therapeutic option for doctors when considering an osteoporosis medicine for their patients,” Black said.

In both study groups, the bone markers were maintained over six years within the normal premenopausal range. In patients who discontinued zoledronic acid 5 mg after three years, there was no evidence of accelerated bone loss.

This builds upon existing data from extensive clinical studies and confirms that zoledronic acid 5 mg helps preserve bone turnover, the balanced process by which the bone is constantly renewed and remodeled throughout adult life.

“Zoledronic acid 5 mg 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 Dr. Trevor Mundel, Novartis AG’s global head of development.

“These long-term data affirm our confidence in the efficacy and safety profile of this medicine,” Mundel said.

Osteoporosis is a condition in which bones become weak and break more easily. According to the International Osteoporosis Foundation, an estimated 75 million people in Europe, the United States, and Japan are affected by this disease and one in three women over the age of 50 as well as one in five men will suffer an osteoporotic fracture in their lifetime.

Approved in more than 90 countries, zoledronic acid 5 mg 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.

These 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.