Researchers Report That
Combination Therapy
Is Effective for Older Women with Osteoporosis
Posted June 30, 2003
University of Pittsburgh researchers have found that
elderly women with osteoporosis can significantly and safely improve their
bone mass with a combination therapy of hormone replacement and the
bisphosphonate alendronate (Fosamax). Their findings are published in the
May 21 issue of the Journal of the American Medical Association.
"Our study found that a combination therapy of hormone
replacement and alendronate was well tolerated by elderly women with low
bone mass. After three years of treatment, these women showed significantly
greater increases in bone mass than we saw in similar women taking only one
of the therapies," said lead author Dr. Susan Greenspan, professor of
medicine at the University of Pittsburgh School of Medicine and director of
the Osteoporosis Prevention and Treatment Center at the University of
Pittsburgh Medical Center. "Combination therapy is a safe, viable option for
postmenopausal women who have been unable to improve their bone density with
an individual therapy, or in women with osteoporosis severe enough to
require a greater increase in bone density."
Earlier research has suggested similar results with
younger women, but up to now little data were available on the effectiveness
and safety of combination therapy in older, post-menopausal women. The study
was conducted with 373 women aged 65 to 90 years. At baseline, participants
as a group had bone mass thin enough to be classified as osteopenia, a
precursor of osteoporosis. Thirty-four percent of the women had
osteoporosis. Participants were evenly randomized to receive hormone
replacement therapy (HRT) (conjugated estrogen with or without
medozyprogesterone) plus alendronate, HRT alone, alendronate alone, or
placebo. All received calcium and vitamin D supplements.
After three years, dual-energy X-ray absorptiometry (DXA)
scans showed that participants taking combination therapy had greater
improvements in bone mineral density (BMD) at the hip and spine than did
those participants taking HRT or alendronate alone, or placebo. For
instance, the mean increase in BMD at the hip was 5.9 percent with
combination therapy, 4.2 percent with alendronate, 3.0 percent with HRT and
0.0 percent with placebo. At the lumbar spine the mean increases in BMD were
10.4 percent with combination therapy, 7.7 percent with alendronate, 7.1
percent with HRT and 1.1 with placebo. Also, in comparing HRT with
alendronate, researchers found that participants taking alendronate alone
had greater improvements in BMD at the hip.
The university news release explains that while the study
was not designed to examine fractures as an outcome, a higher bone density
is usually associated with fewer fractures.
"We applied a logistic model to our data and determined
that combination therapy would provide an additional 10 percent reduction in
fracture over HRT alone and an additional 8 percent over alendronate alone,"
said Dr. Greenspan. "These results can help elderly women decide whether the
potential risk inherent in HRT use is worth taking to reduce the risk of
fracture."
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