Navigation Links
Prolia® (denosumab) Open-Label Extension Trial Showed Continued Increase in Bone Mineral Density Over Six Years With Similar Safety Profile Observed in Original Fracture Trial
Date:11/5/2011

THOUSAND OAKS, Calif., Nov. 5, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced positive data from the first three years of the open-label extension study of the pivotal Phase 3 fracture trial showing that six years of Prolia® (denosumab) treatment in postmenopausal women with osteoporosis was associated with continued increase in bone mineral density (BMD) and consistent reduction in markers of bone turnover. These results will be presented on Nov. 8, 2011, at the 2011 American College of Rheumatology Annual Scientific Meeting in Chicago.

Results of the open-label extension study showed that postmenopausal women with osteoporosis who received up to six years of continued Prolia treatment experienced cumulative gains of 15.2 percent at the lumbar spine and 7.5 percent at the total hip compared with baseline. The overall adverse event profile is consistent with events previously reported.

"These data are consistent with the pivotal Phase 3 fracture study, which first established the efficacy and safety of Prolia in women with postmenopausal osteoporosis at high risk for fractures," said study author Jacques Brown, M.D., CHUQ-CHUL Research Centre, Laval University. "This study provides further evidence of Prolia's long-term clinical potential for women with this chronic disease."

The FREEDOM Study and the 6-Year Prolia Data

The pivotal Phase 3 fracture trial was based on three years of data from approximately 7,800 postmenopausal women. The open-label study extension is evaluating the long-term (up to 10 years) efficacy and safety of Prolia in 4,550 postmenopausal women. Seventy percent of eligible women from the pivotal Phase 3 fracture study enrolled in the study extension; 2,343 women continued to receive Prolia treatment (long-term group), and 2,207 transitioned from placebo to Prolia (cross-over group).

The long-te
'/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. FDA Approves New Indications for Prolia® (Denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
2. Prolia® (Denosumab) Phase 2 Extension Study Showed Continued Increase in Bone Mineral Density Over Eight Years of Treatment
3. Treatment With Prolia® (denosumab) Associated With Significantly Greater Adherence, Compliance and Persistence Compared to Alendronate
4. Prolia® (denosumab) Open-Label Extension Trial Showed Continued Increase in Bone Mineral Density Over Five Years of Treatment With Similar Safety Profile Observed in Pivotal Trial
5. XGEVA® (Denosumab) Granted Marketing Authorization in the European Union
6. Amgen Receives CHMP Positive Opinion for XGEVA™ (Denosumab) in the European Union
7. Results Published in The Lancet Demonstrate Superiority of XGEVA™ (Denosumab) in the Prevention of Bone Complications for Men With Bone Metastases From Advanced Prostate Cancer
8. The Journal of Clinical Oncology Publishes Phase 3 XGEVA™ (Denosumab) Results in Advanced Cancer Patients With Solid Tumors or Multiple Myeloma
9. XGEVA™ (Denosumab) Significantly Improved Bone Metastasis-Free Survival in Men With Prostate Cancer
10. Amgen Presents New XGEVA™ (Denosumab) Breast Cancer Skeletal-Related Event Prevention Data at SABCS
11. Prolia™ (denosumab) Receives Best New Drug Honor at Scrip Awards
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... Show organisers report ... Expo 2014 were a brand new audience ... London , plus a 10% increase ...      (Logo: http://photos.prnewswire.com/prnh/20130723/629764-a) ...      (Photo: http://photos.prnewswire.com/prnh/20140711/696892-b ) ...
(Date:7/10/2014)... , July 10, 2014  Breg, Inc., ... services, has launched the FreeRunner™ knee brace with ... suffer from patella mal-tracking return to active lifestyles. ... than other braces, providing support when patients need ... when they don,t. Patellofemoral issues are ...
(Date:7/10/2014)... , July 10, 2014  Valeant Pharmaceuticals International, Inc. ... announced it has completed the sale to Galderma of ... owned or held by Valeant for $1.4 billion in ... S.A, which recently completed its acquisition of Galderma. ... of our products to a company that is firmly ...
Breaking Medicine Technology:UK's Flagship Health & Safety Event Has Successful Inaugural Year in London 2UK's Flagship Health & Safety Event Has Successful Inaugural Year in London 3UK's Flagship Health & Safety Event Has Successful Inaugural Year in London 4Breg Introduces Knee Brace to Help Runners with Patellofemoral Pain Syndrome 2
(Date:7/12/2014)... United Arab Emirates (PRWEB) July 12, 2014 ... another Los Angeles basketball legend is heading to the ... scorer and six-time champion will be in the UAE ... & Fitness Weekend in support of diabetes awareness. The ... an award-winning entertainment marketing and event management company based ...
(Date:7/12/2014)... Columbus, OH (PRWEB) July 12, 2014 Wright ... representing clients in Just For Men Lawsuits (case ... to inform consumers of reports that allege the popular hair ... serious chemical burns to their face, neck and other areas. ... of Just For Men chemical burns , the advertisements being ...
(Date:7/12/2014)... 12, 2014 Maxim Peptide, a website ... are used solely in scientific experiments, is currently celebrating ... in business, Maxim Peptide, which was created by the ... new and updated website that now features a special ... been updated with fascinating articles about peptide research, including ...
(Date:7/11/2014)... 12, 2014 Recently, MagicQuinceaneraDresses.com, the popular ... new collection of 2014 Quinceanera dresses . The ... want to look fashionable without paying a large amount ... up to 57% off. , The company’s online shop ... get amazing special occasion outfits. In addition to exquisite ...
(Date:7/11/2014)... 2014 According to new report ... is expected to register a CAGR of 2.28% ... 71 market data tables and 76 figures spread ... Market"., http://www.marketsandmarkets.com/Market-Reports/c4isr-market-1315.html , Early buyers will ... , The report provides market analysis of ...
Breaking Medicine News(10 mins):Health News:Los Angeles Basketball Legend Headed to Dubai 2Health News:Los Angeles Basketball Legend Headed to Dubai 3Health News:Just for Men Lawsuit News: TV Campaign Launched by Wright & Schulte LLC to Inform Consumers of the Alleged Association between the Popular Hair Dye and Chemical Burns 2Health News:Just for Men Lawsuit News: TV Campaign Launched by Wright & Schulte LLC to Inform Consumers of the Alleged Association between the Popular Hair Dye and Chemical Burns 3Health News:Just for Men Lawsuit News: TV Campaign Launched by Wright & Schulte LLC to Inform Consumers of the Alleged Association between the Popular Hair Dye and Chemical Burns 4Health News:Maxim Peptide Celebrates Second Anniversary Online with an Updated Website and Special Deals Section 2Health News:Cheap Quinceanera Dresses Now Available At MagicQuinceaneraDresses.com 2Health News:C4ISR Market Estimated to Reach $93.04 Billion by 2019 - New Report by MarketsandMarkets 2Health News:C4ISR Market Estimated to Reach $93.04 Billion by 2019 - New Report by MarketsandMarkets 3Health News:C4ISR Market Estimated to Reach $93.04 Billion by 2019 - New Report by MarketsandMarkets 4
... Magnetic resonance imaging (MRI) findings in patients about to undergo ... that the cancer will return and spread post-treatment, according to ... journal Radiology. , This is the first study to show ... cancer outside the capsule of the prostate is an important ...
... have fewer symptoms of anxiety or depression, while children ... have difficulties forming relationships and being accepted by friends. ... and depression lead to the social problems, or vice ... likely to contribute to anxiety and depression than the ...
... toxic gas responsible for the unpleasant odor of rotten ... aspects of cardiovascular function in mice, producing a suspended-animation-like ... journal Anesthesiology, Massachusetts General Hospital (MGH) reseachers report that ... not depend on a reduction in body temperature and ...
... Responder For Saving Life of ... Femoral Artery, WALLINGFORD, Conn., March 24 Executives ... X. Hursey,Award to Rockland Paramedic Services (RPS) Medic 21 ... QuikClot(R) 1st Response(TM) brand,hemostatic agent to save the life ...
... WASHINGTON, March 24 The following are,remarks by Kent ... of World Tuberculosis Day 2008:, Although a cure ... a,century, TB remains one of three leading causes of ... million people each year,while HIV/AIDS claims more than two ...
... guidance, BOSTON, March 24 AMICAS, Inc. ... medical image and information management,solutions, announced today that ... to AMICAS, board of directors while accepting his ... In addition, the company,has promoted Kevin C. Burns ...
Cached Medicine News:Health News:MRI findings help forecast prostate cancer prognosis 2Health News:Youth's social problems contribute to anxiety and depression 2Health News:Sewer-gas-induced suspended animation is rapid and reversible 2Health News:NY-Area Paramedic Wins 2007 Francis X. Hursey Award for Heroic Use of QuikClot(R) Blood Clotting Product 2Health News:NY-Area Paramedic Wins 2007 Francis X. Hursey Award for Heroic Use of QuikClot(R) Blood Clotting Product 3Health News:Statement from Kent Hill, USAID Assistant Administrator for Global Health, on the Observance of World Tuberculosis Day 2008 2Health News:Statement from Kent Hill, USAID Assistant Administrator for Global Health, on the Observance of World Tuberculosis Day 2008 3Health News:AMICAS Appoints Joseph D. Hill to Its Board of Directors and Promotes Kevin C. Burns to Senior Vice President and Chief Financial Officer 2Health News:AMICAS Appoints Joseph D. Hill to Its Board of Directors and Promotes Kevin C. Burns to Senior Vice President and Chief Financial Officer 3Health News:AMICAS Appoints Joseph D. Hill to Its Board of Directors and Promotes Kevin C. Burns to Senior Vice President and Chief Financial Officer 4
Quantel Medical introduces the new Aviso A/B, a new generation high definition ultrasound system in a unique laptop or desktop PC workstation....
... Air Fluidized Therapy: ,Full-length air ... and provides greater comfort and accelerated ... system can be defluidized to facilitate ... Trendelenburg and Reverse Trendelenburg. CPR procedures ...
... incisional corneal surgery has long ... of the ophthalmology practice. To ... the technical skills and a ... quality. The new "Newman Astigmatic ...
The new TRC-NW200 Non-Mydriatic Retinal Camera combines Topcons years of experience in retinal imaging with the latest advances in digital and electronic technology....
Medicine Products: