Navigation Links
Studies Published in the New England Journal of Medicine Highlight Potential New Option in the Treatment of Bone Loss

THOUSAND OAKS, Calif., Aug. 11 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced the publication of results from two pivotal Phase 3 studies investigating the safety and effectiveness of denosumab at reducing fracture risk in more than 7,800 women with postmenopausal osteoporosis and in more than 1,400 men with non-metastatic prostate cancer undergoing androgen deprivation therapy (ADT) leading to bone loss. In both studies, published today in The New England Journal of Medicine (NEJM), patients receiving twice-yearly denosumab experienced significant increases in bone mineral density (BMD) compared to placebo, associated with more than 60 percent reduction in vertebral fracture in both patient populations.(1,2) These data were previously reported by Amgen at medical congresses.

To view the Multimedia News Release, go to:

"The discovery of the RANK Ligand pathway represents a significant advance in the understanding of bone biology," said Roland Baron, Ph.D., D.D.S., professor and chair of department of Oral Medicine, Infection, and Immunity at the Harvard School of Dental Medicine. "These results demonstrate that targeting the RANK Ligand pathway with denosumab could represent a promising new approach in two different disease settings characterized by bone loss."

FREEDOM Osteoporosis Study Results: Significant Fracture Reduction Seen Across the Skeleton in Postmenopausal Women with Osteoporosis

Results from the FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every six Months) study, showed that women receiving a subcutaneous shot of" target="_new">


  1. Cummings SR, et al. Twice Yearly Denosumab, a Monoclonal Antibody to RANK-ligand, for Prevention of Fractures in Postmenopausal Women with Osteoporosis. N Engl J Med, 2009 Aug. 20; published online at on Aug. 11, 2009.
  2. Smith MR, et al. Denosumab for the Prevention of Bone Loss and Fractures in Men Receiving Androgen Deprivation Therapy in Non-Metastatic Prostate Cancer. N Engl J Med, 2009 Aug. 20; published online at on Aug. 11, 2009.
  3. Melton LJ, et al. (1992) Perspective. How Many Women Have Osteoporosis? J Bone Miner Res, 1992;7:1005
  4. Kanis JA, et al. A Meta-Analysis of Previous Fracture and Subsequent Fracture Risk. Bone, 2004;35:375.
  5. Magaziner J, et al. Predictors of Functional Recovery One Year Following Hospital Discharge for Hip Fracture: A Prospective Study. J Gerontol, 1990;45:M101.
  6. Higano 2008; Higano 2004; Conde 2003; Smith 2001; Pfeilschifter 2000.
  7. Oefelein MG, Ricchiuti V, Conrad W, Resnick MI. Skeletal fractures negatively correlate with overall survival in men with prostate cancer. J Urol. 2002;168:1005-1007.
  8. Burge R, et al. J Bone Miner Res. 2007; 22:465-475
  9. "Osteoporosis Fast Facts." Washington (DC): National Osteoporosis Foundation. Accessed on February 24, 2009 at
  10. "Economic Cost of Cardiovascular Diseases." Dallas (TX): American Heart Association. Accessed on February 24, 2009 at
  11. Lippuner K, et al. "Incidence and direct medical costs of hospitalisations due to osteoporotic fractures in switzerland." Osteoporosis International.1997;7:414-25.
  12. WHO. Media Center. Fact sheet No. 297. February 2009 at

enosumab twice-yearly experienced a 68 percent reduction in the risk of suffering a vertebral (spine) fracture compared to those receiving placebo as well as a 40 percent reduction in the risk of suffering a hip fracture and a 20 percent reduction in the risk of suffering a nonvertebral fracture. Over the three years of this multi-center, randomized, double-blind, placebo-controlled study, women treated with denosumab experienced significant increases in BMD (8.8 percent at the lumbar spine and 6.4 percent at the total hip).(1)

"These results suggest that denosumab offers a new approach to prevention of fractures in women with postmenopausal osteoporosis," said Steven Cummings M.D., lead investigator, study author, and director of the San Francisco Coordinating Center of the California Pacific Medical Center Research Institute. "It reduces the risk of all major types of fractures and, because it is given as an injection twice a year, it also has the potential to help compliance to treatment."

Fracture is one of the most common health events suffered by postmenopausal women with osteoporosis.(3) Globally, one woman in three over 50 years of age will experience a fracture in her lifetime.(3) A woman who has broken a bone as a result of osteoporosis has more than an eight- out-of-ten chance of breaking another bone.(4) Half of women who break a hip, a life changing event, will permanently need assistance to walk.(5)

The overall incidence and type of side effects with denosumab were similar to placebo in the FREEDOM study. Rates of adverse events (AEs) were similar in both groups (93 percent). Rates of serious AEs were 25.8 percent for denosumab and 25.1 percent for placebo. The most common AEs across both treatment arms were arthralgia, back pain, hypertension and nasopharyngitis. There were no reported cases of osteonecrosis of the jaw among patients taking denosumab. Serious adverse events of skin infections, predominantly cellulitis, were reported more commonly in the denosumab group (0.4 percent vs. <0.1 percent). Mild, transient decreases in serum calcium were observed that had no apparent clinical significance.(1)

HALT Study Results: First Published Study to Demonstrate Fracture Prevention in Men with Non-Metastatic Prostate Cancer Undergoing ADT

Results from the HALT (Hormone AbLation Therapy) study in 1,468 men undergoing ADT for non-metastatic prostate cancer show that patients treated with denosumab experienced a 62 percent reduction in the risk of suffering a new vertebral fracture with denosumab compared to placebo at 36 months, with significant reduction observed as early as month-12.(2) Bone loss and increased fracture risk are serious and under-recognized consequences of ADT(6,7) and currently there are no approved therapies for these patients.

In this multi-center, randomized, double-blind, placebo-controlled study, men receiving 60 mg denosumab administered subcutaneously experienced a 6.7 percent increase in BMD at the lumbar spine compared to those receiving placebo (primary endpoint) at 24 months. Increases in BMD at the lumbar spine were observed as early as one month after starting treatment with denosumab and continued to increase throughout the study. In addition, denosumab produced significant increases in BMD at non-vertebral sites (total hip 4.8 percent, femoral neck 3.9 percent, and distal 1/3 radius 5.5 percent), compared to placebo.(2)

"Bone loss and fractures are an important but often unrecognized problem for prostate cancer survivors. Bone loss is an early adverse effect and even short-term androgen deprivation therapy negatively impacts skeletal health. Prevention of bone loss and fractures has been a key unmet medical need for men with prostate cancer," said Matthew Smith, M.D., Ph.D., study author, associate professor of medicine and the director of Genitourinary Medical Oncology at Massachusetts General Hospital Cancer Center. "In this large international study, denosumab markedly increased bone mineral density and decreased the risk of fractures in many men receiving androgen deprivation therapy for prostate cancer. The efficacy of denosumab was apparent as early as one month and was sustained for three years."

In the HALT trial, the overall incidence and type of side effects with denosumab were similar to placebo. Rates of AEs were similar in both groups (87 percent). Rates of serious AEs were 35 percent for denosumab and 31 percent for placebo. The most common AEs across both treatment arms were arthralgia, back pain, constipation, pain in extremity, and hypertension. There were no reported cases of osteonecrosis of the jaw among patients treated with denosumab. More patients receiving denosumab developed cataracts, though none were considered treatment-related. One patient in the denosumab arm developed hypocalcemia, versus none in the placebo arm. New primary malignancies were reported in 5 percent of patients in each group. Serious AEs of infections were reported in 6 percent of denosumab-treated patients and in 5 percent of placebo-treated patients.(2)

"Amgen scientists in the 1990s were the first to identify the RANK Ligand pathway, a pivotal physiologic mechanism that controls bone remodeling," said Roger Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "Today's publications in the New England Journal of Medicine underscore the significance of this finding, and highlight Amgen's focus on using innovative research to address grievous illness."

About Denosumab

Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone). Denosumab is being investigated for its potential to inhibit all stages of osteoclast activity through a targeted mechanism. Denosumab is being studied in a range of bone loss conditions including postmenopausal osteoporosis and bone loss in patients undergoing hormone ablation for prostate and breast cancer.

In February 2009, the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA), submitted by Amgen for denosumab for the treatment and prevention of osteoporosis in postmenopausal women and cancer treatment-induced bone loss in women and men receiving hormone therapy for either breast cancer or prostate cancer based on these studies and a parallel trial in women with breast cancer. The FDA has provisionally approved the trade name Prolia(TM) in these proposed indications, for which denosumab is administered twice yearly subcutaneously at a 60mg dose. The trade name is only for these indications and may not apply for other indications of denosumab.

Amgen has also submitted marketing applications for use of denosumab in the European Union, Canada, Switzerland, and Australia.

Osteoporosis: Impact and Prevalence

Often referred to as the "silent epidemic," osteoporosis is a global problem that is increasing in significance as the population of the world both increases and ages. The World Health Organization (WHO) has recently identified osteoporosis as a priority health issue along with other major non-communicable diseases.

The economic burden of osteoporosis is comparable to that of other major chronic diseases; for example, in the U.S., the costs associated with osteoporosis-related fractures are equivalent to those of cardiovascular disease and asthma.(8,9,10) It has been reported that osteoporosis results in more hospital bed-days than stroke, myocardial infarction or breast cancer.(11)

Bone Loss Due to Hormone Ablation Therapy

Worldwide, prostate cancer and breast cancer are two of the most frequent types of cancer affecting men and women, respectively.(12) In the U.S., prostate cancer is the most common cancer in men and breast cancer is the most common cancer in women. It is common for prostate cancer and breast cancer patients to receive hormone ablation therapies that can lead to a decrease in bone mass and increased risk of fractures. Currently there are no approved therapies for bone loss in patients undergoing hormone ablation for either prostate or breast cancer.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit

Forward-Looking Statements

This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Aug. 11, 2009, and expressly disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.

In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.

    CONTACT: Amgen, Thousand Oaks
    Sarah Reines: (805) 447-9783 (media, osteoporosis)
    Lisa Rooney: (805) 447-6437 (media, oncology)
    Arvind Sood: (805) 447-1060 (investors)


SOURCE Amgen Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Carrington Subsidiary DelSite Initiates Critical Toxicology Studies of Its Nasal Powder Bird Flu Vaccine
2. Advanced Life Sciences to Present Data on Selected Cethromycin Therapeutic Studies at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy
3. Sucampo Pharmaceuticals, Inc. Begins Pivotal Phase III Studies of Oral Lubiprostone to Treat Opioid-Induced Bowel Dysfunction (OBD)
4. Schering-Plough Initiates Phase III Studies with Vicriviroc in Treatment- Experienced HIV Patients
5. Phase 2 Clinical Studies Initiated for a Novel Therapeutic Candidate Identified Through Pharmacopeia Collaboration
6. Ardea Biosciences, Inc. Presents Results of Phase 1 Studies of RDEA806, a Novel NNRTI for HIV, at 47th ICAAC
7. Studies Suggest Key Correlation Between Lung Cancer Subtype and Treatment Outcomes
8. Isis Announces $1.2 Million Award to Its Ibis Subsidiary to Expand Influenza Detection Capabilities and Enable Large-Scale Influenza Transmission Studies
9. Pharmasset Commences Dosing in Phase 3 Registration Studies of Clevudine for HBV
10. Studies Show Body Mass Index Has No Effect on Resolution and Healing of GERD Symptoms
11. Amicus Therapeutics Announces Positive Results From Two Phase 1 Clinical Studies of AT2220 for Pompe Disease
Post Your Comments:
(Date:10/8/2015)... Oct. 8, 2015  Clariant, a world leader in specialty ... facility in Belen, New Mexico , has ... including desiccant canisters and packets and other ... plant is the second Clariant site – the first in ... the ISO 15378:2011 standards, following only the Clariant manufacturing facility ...
(Date:10/8/2015)... , Oct. 8, 2015  Nektar Therapeutics (Nasdaq: ... pain and oncology portfolio during an Investor and Analyst ... p.m. Eastern Time in New York City ... of the NKTR-214 Phase 1/2 clinical program and biomarker ... cytokine designed to preferentially stimulate the production of CD8-positive ...
(Date:10/8/2015)... a clinical stage drug development company focused on advancing ... today the commencement of the US arm of an ... acebilustat, in patients with cystic fibrosis (CF). The study ... the United States and European Union, ... 2016. This landmark clinical trial testing once-daily oral acebilustat ...
Breaking Medicine Technology:
... Texas, Dec. 2, 2010 Ascension Orthopedics, Inc., ... another implantation of the TITAN™ Modular Total Shoulder. ... at Bucks County Specialty Hospital in Bensalem, Pennsylvania. ... postoperative x-rays showed a very anatomic replacement.  The ...
... 2, 2010 Medical devices, biotechnology and IT products ... will present to United States investors and the business ... business and investment opportunities. (Logo: ... successful Chilean Small and Medium Enterprises (SMEs) was selected ...
Cached Medicine Technology:
(Date:10/10/2015)... York, NY (PRWEB) , ... October 10, 2015 , ... ... some alarming numbers on the growth of cybercrime costs for US companies. The New ... on Tuesday, October 6th. With averages showing increases hovering around 20% among the companies ...
(Date:10/10/2015)... , ... October 10, 2015 , ... Isabel Healthcare will ... , On the heels of the release of the Institute of Medicine’s latest report ... their integration with Cerner solutions that assist healthcare providers and consumers to potentially reduce ...
(Date:10/9/2015)... ... October 09, 2015 , ... The American Osteopathic ... for Graduate Medical Education J. Michael Finley, DO, as the recipient of the ... for his impact on graduate medical education opportunities for osteopathic residents, and his ...
(Date:10/9/2015)... ... 2015 , ... A new health tool that helps identify if a sore ... ) – just in time for the cold and flu season, which the ... many in the U.S., the real start of cold/flu season is the start of ...
(Date:10/9/2015)... ... October 09, 2015 , ... Dentist in Huntington ... orthodontic system that uses clear, plastic aligners. This alternative to braces has become ... which allow patients to complete treatment in privacy. Additionally, Invisalign aligners are removable, ...
Breaking Medicine News(10 mins):
... serious problem that can often be fatal. Methadone has ... addicts. However, the major concern in treating heroin addicts ... is one reason methadone therapy is usually only given ... that an alternative drug therapy combined with psychosocial treatment ...
... researchers are currently testing the safety of hypothermia ... injury. Hypothermia treatment has been shown to be ... but its effectiveness in treating children with traumatic ... decreases inflammation, excitotoxicity (excessive neurotransmitters released with injury ...
... of skin cancer and it has been shown through previous ... sunlight, whose UV rays cause damage to DNA that triggers ... are more prone than others to melanoma. Researchers have now ... people with melanoma that those with fair skin// have lowered ...
... Affective Disorder(SAD) is not all that well understood, but ... sunlight in the winter months. Winter depression involves suffering ... days get longer and nights get shorter. Other SAD ... sleeping for longer than usual. Researchers have now found ...
... hospital in Kolkatta, India recently received a patient, a two-month-old ... suffering from a rare disease caused due to a deficiency ... of 10 million children. Doctors said that the baby was ... On detection the baby, a boy child, was found to ...
... time to its ultraviolet rays, has always been said to be ... shown that even moderate sun exposure can result in moles that ... to sun has been shown as the main risk factor for ... rarest type of skin cancer, is much weaker. It has however, ...
Cached Medicine News:
The IRN method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of iron in serum....
For the quantitative in vitro determination of Aspartate Aminotransferase (AST) in serum and plasma....
Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cholesterol in human serum and plasma....
Immunoturbidimetric assay for the quantitative in vitro determination of Lipoprotein (a) in human serum or plasma...
Medicine Products: