ZURICH (Reuters), Sep 18 - Swiss drugmaker Novartis said on Saturday that clinical tests had shown its once-yearly Aclasta medicine had proved effective in reducing incidence of bone fracture in women with postmenopausal osteoporosis (PMO).
According to data from phase III trials presented at a conference in Philadelphia, Aclasta showed benefits across the most common fracture sites -- hip, spine, and nonspine -- with the effects sustained over three years.
PMO patients currently taking Merck & Co Inc.'s oral alendronate Fosamax can be switched to Aclasta and maintain the beneficial bone effects for 12 months after a single dose, the data presented at the meeting of the American Society for Bone and Mineral Research showed.
Osteoporosis is a metabolic disease that causes bones to become more and more fragile, leading to an increased risk of fracture, particularly of the spine, wrist, hip, pelvis, and upper arm.
Aclasta could be the first drug in the multibillion-dollar osteoporosis market, currently dominated by once-a-week treatments, to be administered once a year.
Aclasta met the study's two primary end points as patients experienced a 70% risk reduction in new spine fractures and a 40% risk reduction in hip fractures, Novartis said.
It also met all secondary end points, including risk reduction in clinical spine fractures and nonspine fractures.
The trials showed adverse effects experienced with the drug -- which will be known as Reclast in the U.S. -- were comparable to placebo.
The most common side effects associated with intravenous injection of Aclasta included fever, muscle pain, flu-like symptoms, and bone pain. Most occurred within three days of administration of the drug and were resolved within three days of onset, Novartis said.
About 13,000 patients are participating in the clinical trials program, which involves once-yearly dosing with Aclasta for osteoporosis.
Aclasta, which is also known as zoledronic acid, has been approved in about 50 countries, including the European Union, for the treatment of Paget's disease.
But the Food and Drug Administration has asked for further data from Aclasta's phase III trials in osteoporosis before giving the drug approval for treatment of Paget's disease in the U.S.
An estimated 50.7 million people suffer from osteoporosis in Britain, France, Germany, Japan, Spain, and the U.S.
One in two women with PMO will suffer an osteoporotic fracture. The incidence of hip fracture in women is projected to rise by 240% worldwide by 2050 as populations grow and age, according to Novartis.
By Sam Cage
Last Updated: 2006-09-18 10:24:25 -0400 (Reuters Health)
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