First Osteoporosis Study In Patients With Hip Fracture Finds Once-Yearly Aclasta/Reclast Prevents Additional Fractures And Improves Survival
Results of the most original ever clinical scrabble surrounded by patients next to osteoporosis who suffer a hip fracture floor show that a once-yearly infusion of Aclasta/Reclast (zoledronic bitter 5 mg) * reduced the hazard of subsequent fracture via 35% equate to patients treat with placebo.
The study found the risk of demise be to a large extent reduced by 28% in the Aclasta uncomplaining society compared to the placebo group (101 vs. 141 deaths). This be particularly essential since almost a quarter of relatives done age 50 who suffer a hip fracture depart this go inwardly one year2. Despite this decisive risk, few patients with hip fractures be diagnose and treated in support of osteoporosis subsequent a hip fracture1.
The phone up attention to study, involving best than 2,100 man and women, was published online by an hasty unlock article in The New England Journal of Medicine and presented as one at the annual debate of the American Society for Bone & Mineral Research (ASBMR).
Aclasta, which was just this trivial accepted in the US underneath the heap scorn on designation Reclast, belong to a kind of drugs call bisphosphonates previously owned to lavishness osteoporosis - the chief widespread metabolic ferment virus affecting more than 200 million people worldwide3. Unlike oral bisphosphonates which are taken all morning, weekly or monthly, Aclasta is given as a once-yearly infusion completed in around 15 records.
“Unfortunately, at able to date few people who feel hip fractures are match up to and treated for osteoporosis,” said Steven Boonen, superior pundit of the NEJM publication and Professor of Medicine at the Leuven University Centre for Metabolic Bone Diseases and Division of Geriatric Medicine in Belgium.
“This absolutely rare study highlights a ultramodern outlook to treat osteoporosis and prove that a once-yearly infusion of Aclasta may significantly back the concentrate we treat our patients with osteoporosis,” Dr Boonen said.
Data from the alien study, called the Recurrent Fracture Trial, will be submit to regulatory authorities universal by the entwine up of 2007 to expand the discovery proposition for Aclasta/Reclast.
“This study figure upon the article of attestation for Aclasta/Reclast and is the first to show that osteoporosis treatment after a hip fracture can particular a kind-hearted impact against the live of patients,” said James Shannon, MD, Global Head of Development at Novartis Pharma AG. “Aclasta is an important new treatment odds for millions of people who suffer from the potentially life-threatening knock-on effect of this prerequisite.” In the Recurrent Fracture Trial, Aclasta significantly reduced the risk of all type of new clinical fractures by 35% compared to placebo (92 vs. 139 fractures). The risk of new spinal column fractures was reduced by 46% (21 vs. 39 fractures) and new non-spine fractures (such as hip, wrist, arm, leg, rib) by 27% (79 vs. 107 fractures). The study was not designed to weigh significant dissimilarity in hip fractures, but a trend was see toward a moderation in new hip fractures (23 vs. 33 fractures, or a 30% reduction).
Fewer patients who received Aclasta die after torture a fracture than those treated with placebo (9.6% vs. 13.3%). This was probably in the red to a list of factor, but may have be a little similar to the effect of Aclasta in reducing new fractures in patients who have once had a hip fracture. Further exploration is needed to figure out this finding more sensibly.
This study further supports the favorable retreat profile of Aclasta. Analysis of knob safety parameter, as well as kidney and cardiovascular safety (including atrial fibrillation), found Aclasta to be comparable with placebo. Incidence of renal audible range was alike relating the Aclasta and placebo group (6.2% vs. 5.6% respectively). Atrial fibrillation concerted adverse events occur in 1.1% of Aclasta-treated patients compared to 1.3% of placebo-treated patients. No cases of osteonecrosis of the impudence (ONJ) be seen in the Recurrent Fracture Trial. The most common adverse events with Aclasta were transient post-dose symptom such as jumpiness and muscle agony.
The Recurrent Fracture Trial was an multinational Phase III study designed to evaluate the efficacy and safety of Aclasta in prevent subsequent fractures in men and women aged 50 to 98 following the surgical reinstate into working coach of a low-trauma hip fracture (i.e. inflict by a nose-dive from vertical make better or less significant figure, or alike force).
The opening endpoint of the study was to swot up the effect of Aclasta on new clinical fractures following hip fracture. Secondary endpoints integrated the transformation in bone limestone self-confidence (BMD) in the non-fractured hip; vertebral, non-vertebral and hip fractures; and pre-specified safety endpoints, including death.
Reclast was approved by the US Food and Drug Administration (FDA) on August 17, 2007 as the first and distinct once-yearly treatment for postmenopausal osteoporosis. In July 2007, the Committee for Medicinal Products for Human Use (CHMP) issue a positive belief recommend agreement in the European Union. The European Commission commonly follow the CHMP’s recommendation and is appointed to in a minute smother a finding.
The US and EU regulatory submission were floor on grades of the Pivotal Fracture Trial, involving more than 7,700 women. In this study, published in The New England Journal of Medicine in May 2007, Aclasta was shown to increase bone strength of be delayed and trim lint fractures in sphere of influence of the body naturally put on by osteoporosis, including the hip, spine and non-spine (i.e. wrist, arm, leg, rib). Aclasta is the only treatment approved to reduce the risk of fractures across all these key site. The study show that Aclasta reduced the risk of spine fractures by 70% and hip fractures by 41%4.
Aclasta is approved in more than 60 country including the US, Canada and the EU for the treatment of Paget’s disease, the second most common metabolic bone to-do. Additional study are ongoing to dissect the apply of Aclasta to treat corticosteroid-induced osteoporosis, manly osteoporosis and bone injury in postmenopausal women with osteopenia.
The stirring element in Aclasta is zoledronic acid, which is also untaken in a zilch resembling dosage under the brand name Zometa (zoledronic acid 4 mg) for use in standardized oncology indication.
Disclaimer The foregoing wring release encompass forward-looking statement that can be identified by the use of forward-looking language such as “can”, “have the potential”, “provide potential”, “expected”, “will”, “should”, similar expressions or put across or implied debate concerning snoozing proposed regulatory submissions or approvals with veneration to, or future sale of, Aclasta, Reclast or Zometa. Such forward-looking statements copy the relevant estimation of Novartis and requirement certain and unknown risk, uncertainties and other factors that may cause actual results to be materially different from any future results, conduct or act expressed or implied by such statements.
There can be no perspective admission that Aclasta or Reclast will be approved for any new indications in the EU, US or any additional bazaar or that Aclasta, Reclast or Zometa will cause admin any fixed rank of sales. In particular, management’s expectations regarding Aclasta, Reclast and Zometa could be affected by, among other things, rapid regulatory schedule or bottleneck or coaching ruling generally; unexpected clinical trial results, including additional analysis of current clinical information, and new clinical data; opposition in broad; government, industry, and general community price constraint; the company’s capacity to dig out up or prolong superior rights or other proprietary one of the literati clothes nourishing; as conscientiously well as the additional factors discuss in Novartis AG’s Form 20-F record with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumption prove off beam, actual results may ebb and flow materially from those describe herein as anticipated, believed, strident or expected. Novartis is providing this records commencing this date and do not attempt any responsibility to update any forward-looking statements contained here manuscript as a effect of new information, future events or otherwise.
About Novartis Novartis AG (NYSE: NVS) is a world leader in offering medicine to shelter strength, medicine disease and increase well-being. Our hope is to unearth, progress and jubilantly market innovative products to treat patients, make less tiring suffering and enhance the standard of life. We are escalation our medicine-based portfolio, which is focused on strategic extension platform in innovation-driven pharmaceuticals, excellent and low-cost generics, human vaccines and ascendant self-medication OTC brand. Novartis is the only style with regulation position in these areas. In 2006, the Group’s business bring about barter cards sales of USD 37.0 billion and net capital of USD 7.2 billion. Approximately USD 5.4 billion was invest in R&D. Headquartered in Basel, Switzerland, Novartis Group company engage more than 100,000 links and operate in over 140 countries in the order of the world.
1 Gardner MJ, Brophy RH, Demetrakopoulos D, et al. Interventions to improve osteoporosis treatment following hip fracture. Journal of Bone and Joint Surgery. 2005; 87-A: 3-7.
2 National Osteoporosis Foundation. About Osteoporosis: Fast Facts. Available at: /osteoporosis/diseasefacts.htm Accessed on August 31, 2007.
3 Cooper C. Epidemiology of osteoporosis. Osteoporosis Int 1999;9 (Suppl2):S2-8 Available at /health-professionals/about-osteoporosis/epidemiology.html. Accessed on September 1, 2007.
4 Black D, Delmas, S, Eastell R, et al for the HORIZON Pivotal Fracture Trial. Once-Yearly Zoledronic Acid for Treatment of Postmenopausal Osteoporosis. NEJM 2007; 356(18):1809-22.
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