Eldecalcitol, an Active Vitamin D3 Derivative, Reduces Incidence of New Vertebral Fractures in Osteoporosis Patients in Phase III Clinical Trial.
Eldecalcitol is an active vitamin D3 derivative synthesized by Chugai. It is an agent with superior effect on bone compared to the existing active vitamin D3 agent widely used in Japan. This phase III clinical trial, begun in 2004, was a randomized, double-blind, comparative study to compare the efficacy and safety of eldecalcitol with that of alfacalcidol* in osteoporosis patients. A total of 1,087 patients were randomly allocated to receive a once-daily oral dose of either eldecalcitol or alfacalcidol, and the incidence of new vertebral fractures in both groups was monitored for a period of three years. As a result, patients receiving eldecalcitol showed a significantly lower incidence of bone fractures compared to those receiving alfacalcidol, indicating that eldecalcitol is superior in preventing fractures. The safety profile was similar to that of alfacalcidol, and nothing irregular was observed.
There are an estimated 12 million patients with osteoporosis in Japan. Treatments to increase bone density and quality and thus reduce the incidence of fractures are necessary since osteoporosis-related fractures reduce quality of life, rendering patients bedridden for example, and increase the risk of death. Chugai and Taisho hope that the new drug eldecalcitol will help as many patients with osteoporosis as possible.
Regulatory filing for eldecalcitol is planned for 2009 after the results of the trial have been collated.
* Alfacalcidol is an active vitamin D3 prodrug (Chugai brand name: Alfarol(R)) used in Japan to treat osteoporosis.
Chugai Pharmaceutical Co., Ltd. (TSE: 4519) is one of Japan's leading research-based pharmaceutical companies with strengths in biotechnology products and in the therapeutic fields of oncology, renal diseases, cardiovascular diseases, bone/joint diseases and transplantation/infection/immunity. As a most important member of the Roche group, we aim to become a top Japanese pharmaceutical company by providing a continuous flow of innovative new medicines domestically and internationally. For more information, please visit www.chugai-pharm.co.jp.
About Taisho Pharmaceutical Co Ltd.
Taisho Pharmaceutical Co Ltd. (TSE: 4535) is Japan's leading producer of over-the-counter (OTC) drugs, and the number two OTC drug manufacturer in the world. Taisho is currently endeavoring to strengthen its independent R&D capabilities in the field of prescription pharmaceuticals, and also aggressively pursuing tie-ups with both Japanese and overseas companies. For more information, please visit www.taisho.co.jp/outline/index-e.htm.
Copyright 2008 JCN Newswire. All rights reserved. www.japancorp.net
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|Article Type:||Clinical report|
|Date:||Dec 17, 2008|
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