EAST HANOVER, N.J., May 02, 2007 /PRNewswire/ -- A once-yearly treatment of Reclast(R) (zoledronic acid) Injection significantly reduced the incidence of all types of osteoporotic bone fractures over three years in women with postmenopausal osteoporosis. This study, published today in The New England Journal of Medicine, marks the first time that an osteoporosis treatment significantly reduced all types of fractures in a single study.
Reclast is a bisphosphonate, a class of drugs used to treat osteoporosis, the most common metabolic bone disease affecting more than 10 million people in the US(1). An estimated one out of every two women over age 50 will suffer a broken bone in her lifetime (1).
Unlike other bisphosphonate treatments, where women take daily, weekly or monthly doses for postmenopausal osteoporosis, Reclast is given as a once- yearly 15-minute infusion. Reclast is currently under review by the US Food and Drug Administration (FDA) for the treatment of postmenopausal osteoporosis.
"Unfortunately, many patients who are prescribed oral therapies stop treatment or take less than the full dose throughout a full year, which leads to reduced fracture protection," said Dennis Black, Ph.D., the study's lead author and professor of epidemiology and biostatistics at the University of California, San Francisco. "A once-yearly infusion is an exciting potential treatment option because it offers fracture protection for a full year with one dose."
Results from the study show that Reclast reduced the frequency of fractures among the areas of the body that are typically affected by osteoporosis, including the hip, spine, and wrist. Specifically, a 70 percent reduction was achieved in spine fractures. In the same study, the risk of hip fractures, which are associate d with significant mortality (2), was reduced by 41 percent. Additionally, the reduction in spine fractures was sustained over three years (60 percent in year one, 71 percent in year two, and 70 percent in year three).
"We believe Reclast is an innovative treatment approach for the millions of women with osteoporosis and provides impressive fracture reduction, the primary goal of osteoporosis treatment," said James Shannon, MD, Global Head of Development at Novartis Pharma AG.
About the Pivotal Fracture Trial
The Pivotal Fracture Trial was a Phase III, multi-center, randomized, placebo-controlled study examining the efficacy and safety of Reclast in reducing the risk of bone fracture in women with postmenopausal osteoporosis. The study enrolled more than 7,700 women between the ages of 65 and 89 with postmenopausal osteoporosis in 27 countries. The primary endpoints of the study were new spine and hip fractures over three years compared to placebo. Secondary endpoints included reducing the incidence of non-spine fractures, evaluation of bone mineral density (BMD), normalization of bone turnover markers, and overall safety.
In addition to reductions in spine and hip fractures, the study also demonstrated that Reclast significantly reduced the risk of non-spine, all clinical, and clinical spine fractures by 25 percent, 33 percent and 77 percent respectively.
Bone mineral density increased significantly in the spine by 6.7 percent and the hip by 6 percent in women on Reclast compared to placebo.
In the study, overall incidence of adverse events experienced with Reclast was comparable to placebo. The most common post-dose adverse events with Reclast were fever, muscle pain, flu-like symptoms, headache, and joint pain, most of which occurred within the first three days following Reclast administration. The majority of these symptoms resolved within three days of the event onset. The incidence decreased markedly with subsequent an nual doses of Reclast.
Analysis of key safety parameters, including kidney and bone safety (including osteonecrosis of the jaw), found Reclast to be comparable to placebo. There was an increased number of cases of serious atrial fibrillation observed in the women on Reclast compared to those on placebo (1.3 percent vs. 0.5 percent). These findings have not been observed in other clinical studies or in post-marketing experience from over 1.5 million patients treated with zoledronic acid for oncology indications. Data from a large trial in men and women following hip fracture will provide additional efficacy and safety data for Reclast. These results will be available in the second half of 2007.
HORIZON, the ongoing clinical program of Reclast, is one of the most comprehensive drug evaluation programs ever undertaken in the area of metabolic bone diseases. Approximately 13,000 patients have participated in the program in more than 400 centers worldwide. It is the first program to study a once-yearly dosing regimen for the prevention and treatment of postmenopausal osteoporosis. Other studies involved in the program include prevention of fractures following a hip fracture in men and women, treatment of corticosteroid-induced osteoporosis and male osteoporosis.
Reclast is currently approved by the FDA for the treatment of Paget's disease of bone, the second most common metabolic bone disorder. Reclast is the first and only single-dose infusion regimen approved to treat Paget's disease. Zoledronic acid, under the brand names Reclast or Aclasta(R), is now approved in more than 50 countries, including the US, Canada and the countries of the EU.
The active ingredient in Reclast is zoledronic acid, which is also available under the brand name Zometa(R) (zoledronic acid) Injection for use in certain oncology indications.
Reclast is also under review by the FDA for the treatment of postmenopausal osteoporosis. If approved , Reclast will be the first and only once-yearly bisphosphonate indicated for the treatment of postmenopausal osteoporosis.
Reclast is contraindicated in patients with hypocalcemia (low blood calcium), hypersensitivity to zoledronic acid and in women who are pregnant or are breastfeeding. Reclast contains the same active ingredient found in Zometa. Patients already being treated with Zometa should not be treated with Reclast. Hypocalcemia may occur with Reclast therapy. All patients with Paget's disease should receive 1,500 mg of calcium in divided doses and 800 IU of vitamin D daily, particularly in the two weeks following Reclast administration. Reclast is not recommended for use in patients with severe renal impairment (creatinine clearance <35mL/min). The most common side effects associated with Reclast are fever and chills; pain in the muscles, bones or joints; nausea; fatigue; and headache. Symptoms usually occur within the first three days following Reclast administration and resolve within four days of event onset.
The foregoing press release contains forward-looking statements that can be identified by the use of forward-looking terminology such as "will", "estimated", "potential", "believe", "may", "should", or by express or implied discussions regarding potential future regulatory approvals of Reclast for additional indications, or potential future sales of Reclast. Such forward- looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Reclast will be approved for any additional indications in any market, or that Reclast will reach any particular level of sales. In particular, management's expectations regarding Reclast could be affected by, among other things, unexpected regulatory actions or delays or government regu lation generally; unexpected clinical trial results, including additional analysis of existing clinical data, and new clinical data; competition in general; government, industry, and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; as well as the additional factors discussed in Novartis AG's Form 20-F filed with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG -- a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
(1) National Institutes of Health Osteoporosis and Related Bone Diseases - National Resource Center. Osteoporosis Overview. Department of Health and Human Services. Available at http://www.niams.nih.gov/bone/hi/overview.htm
(2) European Foundation for Osteoporosis and the National Osteoporosis Foundation. Consensus Statement: Who Are Candidates for Prevention and Treatment for Osteoporosis? Osteoporosis Int (1997) 7:106.
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