Zoledronic acid Improves Bone Density in Breast Cancer Patients
May 22, 2005, 22:35, Reviewed by: Dr.
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"These are valuable and encouraging data for the medical community and breast cancer patients. It is exciting that Zometa has shown activity against bone loss in breast cancer patients receiving adjuvant treatment with an aromatase inhibitor."
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By Novartis Pharmaceuticals,
Zometa(R) (zoledronic acid) injection, an intravenous bisphosphonate administered to more than one million patients worldwide, was shown to inhibit aromatase inhibitor-induced bone loss in postmenopausal women treated with Femara(R) (letrozole tablets) in the adjuvant breast cancer setting.
Final data of the primary endpoint of 12-month bone mineral density ( BMD ) demonstrate a significant increase in BMD for those breast cancer patients treated with Femara and upfront Zometa compared with those who received Femara and delayed Zometa. These data were presented at the American Society of Clinical Oncology ( ASCO ) annual meeting in Orlando, Florida.
Several studies have shown that women treated with hormonal therapy in the adjuvant breast cancer setting are at risk of bone loss. New data from the Z- FAST ( Zometa-Femara Adjuvant Synergy Trial ) study offer evidence that Zometa may prevent bone loss in these patients. These data are particularly important given that aromatase inhibitors are a widely prescribed hormonal therapy for newly diagnosed breast cancer.
"These are valuable and encouraging data for the medical community and breast cancer patients," said Adam Brufsky, M.D. Ph.D., co-director, Magee Women's Hospital/UPCI Comprehensive Breast Cancer Center in Pittsburgh, PA and assistant professor of Medicine at the University of Pittsburgh, principal investigator. "It is exciting that Zometa has shown activity against bone loss in breast cancer patients receiving adjuvant treatment with an aromatase inhibitor."
Study results
The Z-FAST study showed that at the 12-month follow-up, the group of patients receiving upfront Zometa had a mean increase of lumbar spine BMD of 1.9% vs. a decrease of 2.4% in the group of patients who received delayed Zometa ( p<0 
- These data were presented at the American Society of Clinical Oncology ( ASCO ) annual meeting in Orlando, Florida.
www.novartis.com
The foregoing release contains forward-looking statements that can be identified by terminology such as "new data," "was shown," "may prevent," "encouraging data," "has shown activity," "potential," "suggest," "may offer" or similar expressions, or by express or implied discussions regarding potential future sales of Femara and/or Zometa. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Femara and/or Zometa to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Femara and/or Zometa will reach any particular sales levels. In particular, management's expectations regarding commercialization of Femara and/or Zometa could be affected by, among other things, additional analysis of Femara and/or Zometa clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government, industry, and general public pricing pressures; and other risks and factors referred to in the Company's current Form 20-F on file with the U.S. 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 anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis Pharmaceuticals Corporation researches, develops, manufacturers and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. 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 ( NYSE: NVS ) -- a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 81,400 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
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