Once a year treatment for osteoporosis now available in the U.S.

Aug 20 2007

A once-a-year treatment for the bone-thinning disease osteoporosis has been given approval by the Food and Drug Administration (FDA) in the United States.

The drug, Reclast, is manufactured by Swiss drugmaker Novartis and is given just once each year via a 15-minute infusion; it is designed for women who suffer from post-menopausal osteoporosis.

One out of every two women over the age of 50 will suffer an osteoporotic fracture in their lifetime and the disease is responsible for 1.5 million fractures every year.

Some of these can have devastating consequences and approximately 20 percent of women over the age of 50 who suffer a hip fracture will die within one year.

Current treatment for osteoporosis consists of pills which are taken daily, weekly or monthly and research shows that more than half of women on daily or weekly bisphosphonates for postmenopausal osteoporosis will discontinue treatment at the end of one year.

Novartis says Reclast could help overcome such problems and ensure women receive a full year of the treatment they need to protect their bones.

Studies by Novartis showed Reclast reduced the risk of spine fractures by 70 percent in more than 7,700 women whereas the more conventional oral drugs typically produce a 40 percent to 50 percent reduction in spinal fractures.

In the Reclast study, about 11 percent of patients who got a placebo had a fracture over three years, compared with 3.3 percent who received the drug but there were at the time concerns about cases of atrial fibrillation, a type of abnormal heart rhythm.

About 1.3 percent of Reclast patients experienced the problem, compared with 0.4 percent of placebo patients and Novartis suggested the timing in the cases implied they were not related to the drug as most appeared more than 30 days after the infusion.

In studies with another drug made by Novartis to treat cancer, which contains the same active ingredient as Reclast, zoledronic acid, the problem did not arise.

Reclast is already sold in the U.S. for treating a bone disorder called Paget's disease and is one of a class of osteoporosis drugs called bisphosphonates.

Oral bisphosphonate pills, including Fosamax, Boniva and Actonel, along with Reclast should be taken on an empty stomach with a full glass of water, and patients must remain upright for at least 30 minutes.

It is estimated that approximately 8 million women in the United States suffer from osteoporosis, a disease characterized by low bone mass and reduced bone strength; it causes bones to break easily and osteoporotic fractures are linked to increased morbidity, along with mortality and healthcare costs.

Outside the United States Reclast is sold as Aclasta; for more information on Reclast, visit www.reclast.com.