THOUSAND OAKS, Calif., Sept. 17, 2011 /PRNewswire/ — Amgen
(NASDAQ:
AMGN) today announced new long-term data showing that
Prolia® (denosumab) treatment for up to eight years in
postmenopausal women with low bone mass or osteoporosis was
associated with a continued increase in bone mineral density (BMD),
an important determinant of bone strength, and a persistent
reduction in markers of bone turnover. The data were presented at
the annual meeting of the American Society for Bone and Mineral
Research (ASBMR) in San Diego.
Results of the Phase 2 study extension showed that for
postmenopausal women with low bone mass or osteoporosis who
received up to eight years of continued treatment with Prolia, BMD
at the lumbar spine and total hip increased on average by 16.8
percent and 6.9 percent as compared to baseline, respectively.
The overall adverse event profile is consistent with events
previously reported.
“We don’t yet have a cure for osteoporosis, and many
postmenopausal women with this condition who are at high risk for
fractures require long-term therapy for this serious disease,” said
lead author Michael McClung, M.D., founding director, Oregon
Osteoporosis Center. “This study provides additional data that
Prolia continues to increase bone mineral density progressively
over a treatment period of eight years. This study supports the
long-term clinical experience of Prolia for women with this chronic
condition.”
This Phase 2 study extension sought to determine the effects of
up to eight years of continued treatment with Prolia on BMD and
bone turnover markers in postmenopausal women with low bone mass or
osteoporosis.
In the original Phase 2 dose-ranging trial for Prolia, 412
postmenopausal women with a BMD T-score (amount of matter per cubic
centimeter of bones) between -1.8 and -4.0 (lumbar spine) and/or
-1.8 and -3.5 (total hip or femoral ne
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