Phase 2 Trial Results of a Pre-Planned Exploratory Analysis in Postmenopausal Women Released at American College of Rheumatology Annual Scientific Meeting
SAN DIEGO, Nov 13, 2005 (BUSINESS WIRE) -- Amgen (NASDAQ:AMGN), the world´s largest biotechnology company,
today announced that twice-yearly subcutaneous injections of denosumab
(60 mg) (previously referred to as AMG 162) increased bone mineral
density (BMD) in the lumbar spine, total hip, distal 1/3 radius and
total body compared to placebo at 24 months. The study also included
an open label FOSAMAX(R)(1) (alendronate) arm. Investigators reported
on a pre-planned exploratory analysis at the American College of
Rheumatology Annual Scientific Meeting in San Diego, California.
The ongoing, multi-center, Phase 2 dose-ranging trial includes
results from 337 healthy postmenopausal women with low BMD who
completed two years of study. Researchers reported denosumab 60mg
increased BMD of the lumbar spine by 7.4 percent in women administered
the therapy twice yearly and 6.2 percent for FOSAMAX(R) 70mg weekly.
Across all doses and dosing intervals, denosumab increased the BMD of
the lumbar spine by 4.3 to 9.0 percent over baseline.
"The two-year results showed the continued effect of denosumab in
increasing bone mineral density in postmenopausal patients with low
bone mass," said Michael Lewiecki, M.D., clinical assistant professor
of medicine, University of New Mexico School of Medicine, Albuquerque,
NM. "These data suggest denosumab, when administered twice a year, may
offer a promising alternative for the prevention and treatment of
Denosumab is designed to target RANK Ligand, a protein that acts
as the primary signal to promote bone removal. In many bone loss
conditions, RANK Ligand overwhelms the body´s natural defense against
Preclinical models have demonstrated that inhibiting RANK Ligand
leads to significant improvements in cortical and trabecular bone
density, volume and strength.
Denosumab is currently being studied for its potential in a broad
range of bone loss conditions including osteoporosis,
treatment-induced bone loss, bone metastases, multiple myeloma and
"Because denosumab targets RANK Ligand, it functions in a way that
is entirely different than other bone loss treatments," said Willard
Dere, M.D., senior vice president of global development and chief
medical officer, Amgen. "We believe its unique, targeted approach to
regulating bone loss may have the ability to transform how we treat
Researchers also reported twice-yearly injections of denosumab (60
mg) increased total hip BMD by 5.1 percent after 24 months. FOSAMAX(R)
70 mg weekly produced a 3.4 percent increase during the same time
period. Denosumab, at all doses and dosing intervals studied,
increased total hip BMD from 2.8 to 5.1 percent. Across all doses and
dosing intervals, distal 1/3 radius BMD increased from 0.6 to 2.5
percent, and total body BMD increased from 0.9 to 4.5 percent.
Occurrence of adverse events was similar among the denosumab,
placebo, and FOSAMAX(R) groups and showed no new pattern of events in
the second year of treatment. No neutralizing antibodies to denosumab
were observed throughout the two years.
Denosumab (AMG 162) Study Design
Investigators randomized 412 postmenopausal women, average age 63,
with low BMD to receive denosumab, placebo or FOSAMAX(R). The purpose
of the study was to determine the safety and efficacy of denosumab on
lumbar spine BMD compared with placebo at 12 months. The doses of
denosumab evaluated included 6, 14 or 30 mg every three months or 14,
60, 100 or 210 mg every six months. The researchers administered all
doses of denosumab via subcutaneous injection. Patients receiving
FOSAMAX(R) followed the approved indication and oral dosing
instructions of 70 mg once weekly.
At entry, the women averaged -2.1 on their T-scores, a
densitometric rating of BMD in which scores between -1.0 and -2.5
indicate osteopenia (thinning bone) and below -2.5 indicate
osteoporosis, according to the World Health Organization (WHO).
The Need for Bone Loss Treatments
Bone loss represents a significant clinical and economic burden.
Osteoporosis is a major public health threat for an estimated 44
million Americans, or 55 percent of the people 50 years of age and
older. In the U.S. today, 10 million individuals are estimated to
already have the disease and almost 34 million more are estimated to
have low bone mass, placing them at increased risk for osteoporosis.
Of the 10 million Americans estimated to have osteoporosis, eight
million are women and two million are men. In addition, one in two
women and one in four men over age 50 will have an
osteoporosis-related fracture in their remaining lifetime.
In Europe, recent estimates have stated that approximately 3.8
million people have experienced bone fractures related to
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(1) FOSAMAX(R) is a registered trademark of Merck & Co., Inc.
Amgen, Thousand Oaks
Christine Cassiano, 805-447-4587 (Media)
Anthony Gringeri, PhD, 805-447-1060 (Investors)