BEIJING, Aug. 21 (Xinhuanet) -- The Novartis drug Reclast has been given approval by the Food and Drug Administration (FDA) of the United States as a once-yearly treatment for postmenopausal osteoporosis, the company said Monday.

    Compared with conventional oral drugs which typically produce a 40 percent to 50 percent reduction in spinal fractures, Reclast reduced the risk of spine fractures by 70 percent in a clinical study involving more than 7,700 women.

    The drug is administered as a 15-minute intravenous injection.

    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.

    The most common side effects reported were pain in the muscles, joints, or bones; flu-like symptoms, and headache.

    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.

    Current treatment for osteoporosis consists of pills which are taken daily, weekly or monthly and a 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.

    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.

(Agencies)