Denosumab Osteoporosis Study Met Primary and All Secondary Bone Mineral Density Endpoints in a Head-to-Head Comparison with Weekly Alendronate (FOSAMAX(R))
THOUSAND OAKS, Calif., Jan 24, 2008 (BUSINESS WIRE) -- Amgen (NASDAQ:AMGN) today announced findings from a head-to-head,
double-blind study comparing the effects of twice-yearly subcutaneous
injections of denosumab versus weekly oral doses of alendronate
(FOSAMAX(R)) on bone mineral density (BMD) in postmenopausal women
with low bone mineral density. The study met primary and all secondary
In this one-year, non-pivotal study, denosumab treatment achieved
significantly greater BMD gains at the total hip, hip trochanter and
distal radius compared with alendronate. For the primary endpoint, the
relative magnitude of BMD improvement at the total hip was
approximately 40 percent greater in the denosumab versus the
alendronate group. The changes in BMD in the alendronate group were
consistent with previously reported studies.
The incidence and types of adverse events observed in this study
were similar between the denosumab and alendronate treatment groups.
The most common adverse events across both treatment arms were
arthralgia, back pain, constipation and dyspepsia.
"We are very encouraged by the results of this head-to-head study
directly comparing denosumab with alendronate, a widely used
osteoporosis treatment," said Roger M. Perlmutter, M.D., Ph.D.,
executive vice president of Research and Development at Amgen. "The
complete analysis of data from this trial will be presented in a
peer-reviewed forum later this year. In addition, we are looking
forward with great anticipation to the results of our large, pivotal
Phase 3 registrational study evaluating the ability of denosumab to
reduce fracture risk in women with post-menopausal osteoporosis.
A total of 1,189 women with postmenopausal osteoporosis were
randomized 1:1 to receive denosumab or alendronate and followed for
one year to assess changes in BMD. The study primary endpoint was to
evaluate the effect of denosumab on percent change from baseline 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 distal
radius compared to alendronate.
Denosumab is the first fully human monoclonal antibody in late
stage clinical development that specifically targets RANK Ligand, the
essential mediator of osteoclasts (the cells that break down bone).
Denosumab inhibits all stages of osteoclast activity through a
targeted mechanism that does not incorporate into bone matrix.
Denosumab is being studied in a range of bone loss conditions
including postmenopausal osteoporosis, rheumatoid arthritis, 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.
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Amgen, Thousand Oaks
Kerry Beth Daly, 516-982-9328 (media)
Arvind Sood, 805-447-1060 (investors)