Osteoporosis Drug Reclast Gets FDA Approval for Women with Postmenopausal Bone Disease

Novartis, the Swiss drug manufacturer, has announced in a press release, that the US Food and Drug Administration (FDA) has approved Reclast, the first and only once-yearly medicine for postmenopausal osteoporosis. This comes as an important new approach in fighting osteoporosis.

The National Osteoporosis Foundation estimates that nearly eight million women are affected by this bone disease in the US. Also, it is estimated that osteoporosis is responsible for more than 1.5 million fractures annually. Fractures include around 19% of Hip fractures, 45% vertebral fractures, 16% wrist fractures, and 20% fractures at other sites.

Osteoporosis is called a "silent disease" because it develops without symptoms and warnings. People affected by this bone disease will know about it when a fracture occurs due to bone weakness. A sudden strain, bump or fall may cause a fracture or o vertebra collapse.

The newly FDA approved drug (Reclast: zoledronic acid) should be taken once a year only, in contrast with several others that have to be taken daily, weekly or monthly. Reclast is to be given in one treatment of 15-minute intravenous (IV) infusion for a one year full protection.

Reclast belongs to a group of drugs called bisphosphonates. Bisphosphonates (also called diphosphonates) is a class of drugs that inhibits the resorption of bone. When attached to bone tissue, biphosphonates are "ingested" by osteoclasts, the bone cell that breaks down bone tissue.

In a recent study, Black et al. (2007) (see reference bellow) showed that a single 15-minute infusion of zoledronic acid (5 mg) was able to reduce the risk of morphometric vertebral fracture by 70% during a 3-year period. Zoledronic acid was also associated with a significant improvement in bone mineral density and bone metabolism markers. The study was based on 3889 patients (mean age, 73 years) that received the single 15-minute infusion of zoledronic acid (5 mg) against 3876 who received a placebo.