ParfumGigi@aol.com

Contributed by William Angelos| 19 September, 2007 03:08 GMT

People with osteoporosis who have suffered a hip fracture are less likely to experience another fracture if administered zoledronic acid, a once-yearly drug marketed under the brand name "Reclast." That is the conclusion of researchers who conducted a study involving 2,100 participants, which is published in the New England Journal of Medicine.

The Recurrent Fracture Trial -- the first study of its kind -- found that the patients who were given Reclast had a 35 percent lower risk of subsequent fractures than did the patients who received a placebo.

Additionally, the risk of death was reduced in the Reclast group by 28 percent compared to the placebo group.

Osteoporosis is often underdiagnosed and undertreated, according to Ethel Siris, MD, professor of clinical medicine at Columbia University Medical Center.

Almost 25 percent of osteoporosis patients over 50 die within a year of suffering a hip fracture, according to the National Osteoporosis Foundation.

Half of those who survive require assistance walking, and a quarter need long-term nursing care. All of them remain at high risk for subsequent fractures.

Still treatment for osteoporosis following a hip fracture is not routinely provided.

"This study underscores the importance of more aggressive evaluation and management of patients with osteoporotic fractures, including hip fracture," said Dr. Siris. "We know that such patients are at very high risk of future fractures, and it is critical that we lower that risk to reduce the human suffering and economic costs from this disease worldwide."

The Recurrent Fracture Trial is the first study "to show that osteoporosis treatment after a hip fracture can have a positive impact on the lives of patients," said James Shannon, MD, global head of development at Novartis Pharma. "Reclast is an important new treatment option for millions of people who suffer from the potentially life-threatening consequences of osteoporosis."

The study results show that Reclast significantly reduced the risk of all new clinical fractures by 35 percent. The risk of new spine fractures was reduced by 46 percent, and new non-spine fractures -- that is, fractures of the hip, wrist, arm, leg or rib -- were down by 27 percent. The study was not designed to measure significant differences in hip fracture, but a trend was seen towards reduction in new hip fractures (30 percent).

Fewer patients who received Reclast died following a fracture than those treated with placebo (9.6 percent compared with 13.3 percent). The authors point out that the reduction in mortality is probably due to several factors, but suggest that a reduction in subsequent new fractures following the hip fracture may have contributed to the result.

Reclast was approved by the US Food and Drug Administration in August as the first and only once-yearly treatment for postmenopausal osteoporosis.