Navigation Links
Phase III Trial Showed Investigational Compound Arzoxifene Was Superior to Evista(R) (raloxifene HCl) in Increasing BMD in Postmenopausal Women with Osteoporosis
Date:3/23/2009

Results from the "NEXT" Study Also Showed Arzoxifene Significantly Suppressed Bone Turnover Markers versus Raloxifene in Postmenopausal Women with Osteoporosis

ATHENS, Greece, March 23 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) presented new data showing arzoxifene, an investigational selective estrogen receptor modulator (SERM), was superior to raloxifene at increasing bone mineral density (BMD) in the lumbar spine, total hip and femoral neck, and at suppressing bone turnover as assessed by serum markers of bone metabolism. In this study of 320 patients, more women reported bronchitis and nasopharyngitis in the arzoxifene group versus the raloxifene group, whereas significantly fewer women reported new or worsening hot flushes in the arzoxifene group. The data were presented at the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ECCEO) annual meeting.

Arzoxifene is being studied for the prevention and treatment of osteoporosis in postmenopausal women and the reduction of risk of invasive breast cancer in postmenopausal women with osteoporosis or low bone mass.

About the "NEXT" Study

Arzoxifene versus Raloxifene: 12-month Effects on Bone Mineral Density, Bone Turnover Markers, and Safety Parameters in Postmenopausal Women with Osteoporosis

This Phase III trial, powered to show superiority, was a double-blind, active comparator, controlled, 12-month study. In the study, 320 postmenopausal women with osteoporosis were randomized to receive arzoxifene 20 mg/day (N= 158) or raloxifene hydrochloride 60 mg/day (N= 162). In addition, supplements containing 500 mg/day calcium and 400-600 IU/day vitamin D were provided. The study's primary endpoint was lumbar spine BMD. Secondary objectives included assessment of femoral neck and total hip BMD, serum bone turnover markers, mammographic breast density and safety.(1) The study included postmenopausal women with osteoporosis with a mean age of 63 years and a mean lumbar spine BMD T-score of -2.9.

12-month results included:(1)

  • Arzoxifene significantly increased BMD at all sites to a greater extent than raloxifene, respectively (p<0.05 for all comparisons):
    • Lumbar spine BMD (2.8 percent vs. 1.7 percent)
    • Femoral neck BMD (1.5 percent vs. 0.5 percent)
    • Total hip BMD (1.5 percent vs. 0.8 percent)
    • For lumbar spine and femoral neck, this effect was statistically significant as early as six months.
  • Arzoxifene significantly suppressed bone turnover to a greater extent than raloxifene, respectively (p<0.05 for all comparisons):
    • CTX (biochemical marker of bone resorption); -40.6 percent vs. -29.8 percent
    • PINP (biochemical marker of bone formation) : -41.5 percent vs. -30.8 percent
    • Arzoxifene suppressed bone turnover to a greater extent than raloxifene as early as three months.
  • New or worsening hot flushes were reported less frequently with arzoxifene versus raloxifene (7.0 percent vs. 16.7 percent; p=0.009).
  • There were not any between-group or within-group differences in change of percentage of breast density.
  • The proportion of women reporting one or more adverse events, including vaginal bleeding, did not differ between treatment groups.
  • No cases of endometrial polyps, hyperplasia or cancer were reported.
  • Nasopharyngitis and bronchitis were reported more frequently with arzoxifene versus raloxifene (10.1 percent vs. 2.5 percent, and 5.1 percent vs. 0 percent, respectively; p less than or equal to 0.005).

"The significant increases in BMD and suppression of markers of bone turnover seen in these data show the potential benefits of arzoxifene for the treatment of osteoporosis in postmenopausal women," said investigator Jose Zanchetta, M.D., specialist in osteology and mineral metabolism, Metabolic Research Institute, Buenos Aires, Argentina. "I'm encouraged by these results and interested in seeing the next Phase III data for arzoxifene."

These data are from the "NEXT" Study, the second of three Phase III trials for arzoxifene. In September 2008, results from the "FOUNDATIONS" Phase III prevention study were first presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Montreal. The third Phase III trial, the "GENERATIONS" Study, is a 5-year, randomized, double-blind, placebo-controlled study assessing the effects of arzoxifene on vertebral fracture incidence and on invasive breast cancer incidence in postmenopausal women with osteoporosis or with low bone density. Results from that trial are anticipated in late 2009.

"We are pleased with the results of the 'NEXT' Study and its implications for arzoxifene as a potential treatment option for postmenopausal women with osteoporosis," said Adrien Sipos, M.D., Ph.D., medical director for Eli Lilly and Company. "We are committed to research that will help bring innovative prevention and treatment options to patients suffering from this devastating disease, which affects one in three women over 50." (2)

Osteoporosis is a disease in which bones become fragile and more likely to break. Primary osteoporosis, which is deterioration of bone mass that is unassociated with other chronic illness, is related to aging and decreased gonadal function, including menopause. If not prevented, or if left untreated, osteoporosis can progress painlessly until a bone breaks. These broken bones, or fractures, typically occur in the hip, spine and wrist. According to the International Osteoporosis Foundation, 30 percent to 50 percent of women will suffer a fracture related to osteoporosis in their lifetime.(2)

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs.

P-LLY

This press release contains forward-looking statements about the safety and efficacy of arzoxifene and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that arzoxifene will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

(1) Zanchetta, J., et al. "Arzoxifene versus Raloxifene: 12-month Effects on Bone Mineral Density, Bone Turnover Markers, and Safety Parameters in Postmenopausal Women with Osteoporosis." Osteoporosis International 2009;20:166.

(2) International Osteoporosis Foundation. Facts and Statistics About Osteoporosis and its Impact. Available at:http://www.iofbonehealth.org/facts-and-statistics.html#factsheet-category-17. Accessed October 29, 2008.

(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )


'/>"/>
SOURCE Eli Lilly and Company
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Micromet Has Started a New Phase 2 Trial with Adecatumumab in Colorectal Cancer Patients
2. Innocoll Announces Dosing of Last Patient in Second US Phase 3 Clinical Trial to Investigate GENTAMICIN SURGICAL IMPLANT for Prevention of Surgical Site Infections in Colorectal Surgery Patients
3. Cephalon Announces Positive Results From a Phase Two Study of NUVIGIL in Bipolar Depression
4. Walter Reed Army Medical Center offers HIFU for Qualifying Men with Locally Recurrent Prostate Cancer in a Phase III Clinical Trial
5. Healthpoint Initiates Phase II, Dose-Finding Study to Evaluate Effectiveness of a Unique Cell Based Therapy in Venous Leg Ulcers
6. DURECT Reports Positive Phase IIb Data from TRANSDU(TM)-Sufentanil Clinical Program
7. Innocoll Announces Dosing of Last Patient in US Phase 3 Clinical Trial to Investigate GENTAMICIN SURGICAL IMPLANT for Prevention of Surgical Site Infections in Cardiac Surgery Patients
8. Video: Provectus PV-10 Interim Phase 2 Safety and Efficacy Results are as Good as or Better than Phase 1 Results
9. Nobilon Advances First Vaccine Into Human Trials - Intranasal Influenza Vaccine Begins Phase I Clinical Development
10. Rigel Commences Phase 2 Trial of R788 in Peripheral T-Cell Lymphomas
11. Oncolytics Biotech(R) Inc. Announces Start of Enrolment in U.S. Phase 2 Combination Clinical Trial for Non-Small Cell Lung Cancer Patients with K-RAS or EGFR-Activated Tumours
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , Belgium , June 24, ... VNRX), today announced the appointment of Dr. ... Directors as a Non-Executive Director, effective June 23, ... Audit, Compensation and Nominations and Governance Committees.  As ... Futcher will provide independent expertise and strategic counsel ...
(Date:6/23/2016)... 2016 Research and Markets has ... by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), ... Parenteral) - Global Forecast to 2021" report to ... The global pharmaceutical excipients market is projected to reach ... 6.1% in the forecast period 2016 to 2021. ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... their offering. The current ... environment for MedImmune to enter. The US ageing population creates ... drive considerable growth for effective anti-influenza medications. The introduction of ... but development is still in its infancy. ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer is ... a fitness app. The fitness app plans to fix the two major problems leading the ... one size fits all type program , They don’t eliminate all the reasons ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Austin residents seeking ... American College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical ... effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding ... of its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. ... James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, ... Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments in ... the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in ...
(Date:6/24/2016)... ... ... Those who have experienced traumatic events may suffer from a complex set of ... or alcohol abuse, as a coping mechanism. To avoid this pain and suffering, Serenity ... event. , Trauma sufferers tend to feel a range of emotions, from depression, guilt, ...
Breaking Medicine News(10 mins):