Additional Data From Separate Head-to-Head Trial Showed More Than 75 Percent of Patients Prefer the Administration and Frequency of Twice-Yearly Subcutaneous Injection Compared to Weekly Oral Pill
MONTREAL--(BUSINESS WIRE)--Sept. 15, 2008--Amgen (NASDAQ:AMGN) today announced full data results from a non-pivotal Phase 3 head-to-head, double-blind trial comparing bone mineral density (BMD) gains in postmenopausal women with low bone mass who transitioned from weekly oral alendronate (Fosamax(R)) to denosumab versus those who continued alendronate therapy. In addition, patient preference data from another non-pivotal head-to-head trial comparing denosumab to weekly oral alendronate were announced today at the 2008 American Society of Bone and Mineral Research (ASBMR) Annual Meeting in Montreal.
"Data from these trials highlight the potential for a new treatment option for the millions of postmenopausal women worldwide with osteoporosis," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "In the bisphosphonate transition study, it is particularly exciting to see significant bone density gains in patients on denosumab who previously were treated with alendronate, as this type of result has not been reported in any previous study transitioning patients from one bisphosphonate to another. We believe these data coupled with data from a separate Phase 3 head-to-head trial that reported patient preference for twice-yearly subcutaneous injections versus a weekly oral therapy suggest denosumab offers the promise to be a welcome new option for patients."
Effect of Denosumab versus Alendronate on Bone Mineral Density (BMD) and Bone Turnover Markers (BTM) and Safety in Women Previously Treated with Alendronate (Abstract # 646)
Data presented from the bisphosphonate transition study, also known as the STAND (Study of Transitioning from AleNdronate to Denosumab) trial, demonstrated that subcutaneous injections of denosumab every six months achieved significantly greater increases in BMD versus those achieved with alendronate at all sites measured. For the primary endpoint, denosumab resulted in significant increases in BMD at the total hip compared with alendronate (1.9 percent vs. 1.05 percent, p less than 0.0001). Treatment with denosumab also resulted in significant increases in BMD compared with continued alendronate treatment at all secondary endpoints including the lumbar spine, femoral neck, hip trochanter and 1/3 radius. Top-line results of this trial were previously released in May 2008.
The incidence and types of adverse events observed in the study, including neoplasm and infection, were well-balanced between the denosumab and alendronate treatment groups. The most common adverse events across both treatment arms were back pain, arthralgia, and nasal pharyngitis.
Preference and Satisfaction with a 6-monthly Subcutaneous Injection Versus a Weekly Tablet for Treatment of Low Bone Mass (Abstract # 434)
As part of the DECIDE (Determining Efficacy: Comparison of Initiating Denosumab vs. AlEndronate) trial, patients were given a questionnaire after 12 months of treatment to gauge preference on mode of administration as well as satisfaction with frequency of dosing of twice-yearly subcutaneous injections versus weekly oral tablet. More than three-quarters of patients in both study arms preferred subcutaneous injection over oral pills (77 percent vs. 23 percent, p less than 0.0001). In addition, significantly more patients were more satisfied with twice-yearly dosing compared to weekly dosing (80 percent vs. 20 percent placebo injection vs. weekly oral alendronate, and 79 percent vs. 21 percent denosumab vs. weekly placebo tablet, p less than 0.0001 for both study groups). The BMD data from this study will be presented at ASBMR in the scientific oral session on Tuesday, Sept. 16.
About the 234 Bisphosphonate Transition Study (STAND)
The 234 bisphosphonate transition Phase 3 study was a randomized, double-blind, active controlled, parallel group study. Eligible patients had T-scores of less than -2.0 and greater than -4.0 at the lumbar spine or total hip, and had previously been treated with alendronate. A total of 504 women with low BMD participated in the study, with approximately 250 patients in each arm.
The study's primary endpoint was to evaluate the effect of denosumab treatment (twice-yearly 60 mg) on total hip BMD in women with low bone mass compared to patients continuing alendronate therapy (weekly 70 mg) at 12-months. The secondary endpoints included evaluation of the effects of transitioning to denosumab compared to continuing treatment with alendronate on percent change from baseline in BMD at the lumbar spine, hip trochanter, femoral neck, and 1/3 radius.
About the 141 Head-to-Head Study (DECIDE)
In this Phase 3 double-blind, double-dummy, active controlled study, 1,189 healthy postmenopausal women (T-score less than or equal to -2.0 total hip or spine), were randomized 1:1 to receive either denosumab injection (subcutaneous 60 mg, Q6M) plus placebo tablet (oral weekly), or placebo injection and oral alendronate (70 mg weekly). Patients were followed for one year to assess changes in BMD at the total hip compared to alendronate. Secondary endpoints were to evaluate the effect of denosumab on percent change from baseline in BMD at the lumbar spine, hip trochanter, femoral neck, and 1/3 radius compared to alendronate. Preference and satisfaction were assessed after 12-months of treatment, with patients being asked to complete a 34-item questionnaire to rate their preference and satisfaction with each mode and frequency of administration.
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, rheumatoid arthritis, and cancer treatment-induced bone loss (in breast cancer and prostate cancer patients), as well as for its potential to delay bone metastases and inhibit and treat bone destruction across many stages of cancer.
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. More than 75 million people in Europe, Japan and the United States (U.S.) have osteoporosis, and most have an estimated lifetime risk for wrist, hip and vertebral fractures of around 15 percent, very similar to that of coronary heart disease. 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. It has been reported that osteoporosis results in more hospital bed-days than stroke, myocardial infarction or breast cancer.
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