The New England Journal of Medicine published the reports of a study in osteoporosis patients who have had a hip fracture. The study revealed that giving the Novartis osteoporosis drug reclast could prevent subsequent fractures and help patients live longer.
The data from new study, Recurrent Fracture Trial, included more than 2,100 men and women has shown that once-yearly infusion of aclasta/reclast injection reduced the risk of subsequent fractures by 35 per cent compared to placebo.
The study found the risk of death was significantly reduced by 28 per cent in the aclasta patient group compared to the placebo group (101 vs. 141 deaths respectively). This is especially important since almost a quarter of people over age 50 who suffer a hip fracture die within a year. Despite this significant risk, few patients with hip fractures are diagnosed and treated for osteoporosis following a hip fracture, the company stated.
Aclasta, which was recently approved in the US under the brand name reclast, belongs to a class of drugs called bisphosphonates used to treat osteoporosis - the most common metabolic bone disease affecting more than 200 million people worldwide. Unlike oral bisphosphonates, which are taken daily, weekly or monthly, aclasta is given as a once-yearly infusion completed in approximately 15 minutes.
"Unfortunately, at present few people who experience hip fractures are evaluated and treated for osteoporosis. This unique study highlights a novel approach to treating osteoporosis and proves that a once-yearly infusion of Aclasta may significantly advance the way we treat our patients with osteoporosis," said, Steven Boonen, senior author of the NEJM publication and Professor of Medicine at the Leuven University Centre for Metabolic Bone Diseases and Division of Geriatric Medicine in Belgium, a company press release said.
In the Recurrent Fracture Trial, aclasta significantly reduced the risk of all types of new clinical fractures by 35 per cent compared to placebo (92 vs. 139 fractures). The risk of new spine fractures was reduced by 46 per cent (21 vs. 39 fractures) and new non-spine fractures (such as hip, wrist, arm, leg, rib) by 27 per cent (79 vs. 107 fractures). The study was not designed to measure significant differences in hip fractures, but a trend was seen toward a reduction in new hip fractures (23 vs. 33 fractures, or a 30 per cent reduction), said a company press release.
"This study builds upon the body of evidence for aclasta/reclast and is the first to show that osteoporosis treatment after a hip fracture can have a positive impact on the lives of patients. Aclasta is an important new treatment option for millions of people who suffer from the potentially life-threatening consequences of this condition," said, James Shannon, managing director, global head of development, Novartis Pharma AG.
Fewer patients who received Aclasta died after suffering a fracture than those treated with placebo (9.6 per cent vs. 13.3 per cent). This was probably due to a range of factors, but may have been partly related to the effect of aclasta in reducing new fractures in patients, who previously had a hip fracture, said the Swiss drug maker in a statement.
Incidence of renal events was similar between the aclasta and placebo groups (6.2 per cent vs. 5.6 per cent respectively). Atrial fibrillation serious adverse events occurred in 1.1 per cent of Aclasta-treated patients compared to 1.3 per cent of placebo-treated patients. No cases of osteonecrosis of the jaw (ONJ) were seen in the trial. The most common adverse events with Aclasta were transient post-dose symptoms such as fever and muscle pain.
The trial was an international phase III study designed to evaluate the efficacy and safety of aclasta in preventing subsequent fractures in men and women aged 50 to 98 following the surgical repair of a low-trauma hip fracture, caused by a fall from standing height or less, or equivalent force, the company said.
Reclast, approved by the US FDA on August 17, 2007, is awaiting approval from the European Union. In July 2007, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval in the European Union. The European Commission generally follows the CHMP's recommendations.
The US and EU regulatory submissions were based on results of the pivotal fracture trial, involving more than 7,700 women. In this study, aclasta was shown to increase bone strength and reduce fractures in areas of the body typically affected by osteoporosis, including the hip, spine and non-spine (i.e. hip, wrist, arm, leg, rib). The study showed that Aclasta reduced the risk of spine fractures by 70 per cent and hip fractures by 41 per cent.
Aclasta is approved in more than 60 countries for the treatment of Paget's disease, the second most common metabolic bone disorder. Additional studies are ongoing to examine the use of aclasta to treat corticosteroid-induced osteoporosis, male osteoporosis and bone loss in postmenopausal women with osteopenia. The active ingredient in aclasta/reclast is zoledronic acid, which is also available in a different dosage under the brand name Zometa Injection for use in certain oncology indications.