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Long-Term Data Show Novartis Once-Yearly Reclast Preserves Bone Mass and Provides Fracture Protection in Postmenopausal Osteoporosis

Sat, 10/16/2010 - 4:31pm
Bio-Medicine.Org

EAST HANOVER, N.J., Oct. 16 /PRNewswire/ -- Novartis announced today that new six-year data reinforce the long-term efficacy and safety profile of once-yearly Reclast® (zoledronic acid) injection in postmenopausal women with osteoporosis.(1) The study of more than 1,200 women was presented this weekend at the annual meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, ON, Canada.

The study showed that Reclast maintained bone mass in postmenopausal osteoporotic patients who received annual infusions for six years.(1) In patients who stopped Reclast treatment after three years, the bone mineral density (BMD) decreased significantly but remained well above the levels measured at the beginning of the study (difference between the two groups at six years: 1.04%, p-value = 0.0009).(1)

Patients who stayed on Reclast therapy for six years reduced their risk of new morphometric spine fractures by 52%, compared to those who stopped treatment at three years (p-value = 0.04).(1) Morphometric fractures can occur unaccompanied by pain and therefore may not be diagnosed and treated; they can be felt or seen over time in the form of back pain, loss of height, or stooped posture.(4)

"These new findings show that continued treatment with zoledronic acid for six years continues to maintain bone mass and reduce vertebral fractures risk with no change to its favorable safety profile compared to discontinuation of treatment after three years," said Dennis Black, PhD, the study's lead author and Professor of Epidemiology and Biostatistics at the University of California, San Francisco.  "These new long-term data reconfirm Reclast as an important therapeutic option for doctors when considering osteoporosis treatment for their patients."

In both study groups, the bone markers were maintained over six years within the normal premenopausal range.(1) In patients who discontinued Reclast after three years, there was no evid

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