Single-dose therapy given once a year shown to provide significant bone protection benefits and may improve long-term treatment compliance
Amman - Jordan - Aclasta® (zoledronic acid 5 mg) has received the Jordan Food and Drug Administration (JFDA) approval as the first once-yearly bisphosphonate treatment for the bone disorder postmenopausal osteoporosis. Aclasta® was launched in Jordan during a seminar hosted by Novartis on January 27th 2009 held at Le Meridian Hotel.
Aclasta® is already approved in more than 50 countries, including the EU, US and Canada, for use in patients with Paget's disease, a chronic disorder that causes abnormal bone growth, and postmenopausal osteoporosis disorder. It is an important step forward for women with osteoporosis. A single once-yearly 15-minute infusion of Aclasta® enables patients to receive a full year of medication in one setting.
Osteoporosis (literally "porous bones") is the most common metabolic bone disease and causes the bones to become more and more fragile, leading to an increased risk of fracture, particularly of the spine, wrist, hip, pelvis and upper arm. An estimated one out of two women over age 50 will suffer a broken bone as a result of osteoporosis in their lifetime, resulting in a significant increase in deaths, disabilities, injuries and healthcare costs.
"Current oral therapies for osteoporosis have to be taken daily, weekly or monthly, and patients often find it difficult to follow these treatment regimens. As a result more than 50% of patients are non-compliant with therapy after a year," said Erik Fink Eriksen, Professor of Endocrinology and Internal Medicine, Section Head Aker University Hospital, University of Oslo, Norway, a guest speaker at the seminar. "Aclasta® with a single treatment offers a full year's compliance and protection against the effects of osteoporosis and the risk of life-threatening fractures, and Patients can safely switch from oral bisphosphonates to Aclasta®."
Based on an extensive review of data from clinical studies in osteoporosis that includes data from the 7,700-woman Pivotal Fracture Trial, published recently in The New England Journal of Medicine. Aclasta® use has demonstrated a 70% reduction in vertebral fractures in women compared to those on placebo, while the risk of hip fractures - which are associated with significant mortality in older people - was reduced by 41% compared with placebo. This is the first time that one treatment has been shown in a single study to provide protection against all types of osteoporotic fractures across all major sites - spine, hip and other non-spinal fractures.
Aclasta® belongs to a class of drugs called bisphosphonates, considered the standard of care for patients with osteoporosis and Paget's disease. Aclasta® works by attaching to bone, stopping excessive breakdown and rebalancing the body's natural bone remodeling process.
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© Press Release 2009
