June 20, 1997, Baltimore
Some 30 to 40 percent of postmenopausal women suffer from
osteoporosis, the "bone-thinning" disease that
results in a bone so brittle and easily fractured that it
can break spontaneously. In the U.S. alone, the cost of
treating such fractures is about $10 billion a year. A
hip fracture can turn a self-sufficient, active woman
into one who needs constant care and even cause her
death. But a new drug, Alendronate, can reduce the risk
of fracture. In five different studies involving 1,602
women, researchers reporting in a recent issue of the
Journal of the American Medical Association found that
the drug reduced fractures by nearly 30 percent and that
those who took the drug also experienced increased bone
mineral density. In this InteliHealth interview, Edward
E. Wallach, J. Donald Woodruff professor of gynecology at
the Johns Hopkins Medical Institutions, says he believes
the drug shows great promise.
InteliHealth: How does Alendronate work?
Dr. Wallach: It's a member of a family of drugs called
bisphosphonates. These drugs have an effect on the bone
matrix. It was first used in patients with Paget's
disease, a disease where continued destruction of the
bone occurs. The first of these drugs was etidronate,
used exclusively for Paget's disease; then doctors
started using it to treat osteoporosis. But it was
difficult to give, it had to be given for two weeks at
three-month intervals. Alendronate can be given on a
daily basis, which makes it easy to take. It works on
strengthening the bone matrix.
IH: How does it accomplish that?
Dr. Wallach: It prevents three types of fractures:
forearm fractures, hip fractures - which is probably the
most significant in terms of mobility and mortality - and
vertebral collapse. There are two types of cells in
bones: osteoblasts, which build bone, and osteoclasts,
which cause bone to reabsorb. This drug prevents the
reabsorption of bone.
IH: Should most post-menopausal women take this drug?
Dr. Wallach: No. Only those who have osteoporosis or a
significant risk for osteoporosis need to take this.
IH: Is Alendronate a better choice for women at risk of
osteoporosis than hormone replacement therapy?
Dr. Wallach: It would be ideal if a postmenopausal woman
at high risk for osteoporosis would receive both
estrogens and Alendronate.
IH: What are Alendronate's side effects, if any?
Dr. Wallach: The most significant side effect is
esophageal irritation, which is true of all drugs in this
group of compounds. It probably causes acid to enter the
esophagus and cause the irritation. But that can be
reduced by the way a woman takes the drug. The drug must
be taken 30 minutes before eating, since food prevents
its absorption. The woman should take it when she first
gets up, standing, with a full glass of water. Then she
can't lie back down. She should take it 30 minutes before
breakfast. But that's kind of difficult for working
women. I personally don't know why it can't be taken in
the afternoon; I suspect it's because the morning is when
there is the longest period of time without food in the
IH: Is it safe in the long term?
Dr. Wallach: The drug has been studied for a number of
years. Before it was released, there were three-year
studies to evaluate its use, and it's fairly safe. But
the length of time on the market is relatively limited,
so we don't have long-term data.
also Prevents Bone Fractures In Women
Women with low bone density but who have not yet had tiny
spinal fractures indicative of osteoporosis can take the
drug Fosamax to prevent broken bones, a new study
Women taking Fosamax, also known as alendronate, had a
44% reduced risk of such spinal fractures and a 14% lower
risk of broken bones in general, according to the report
scheduled to be released Thursday at the American Society
for Bone and Mineral Research annual meeting in
About 200 million women around the world suffer from
osteoporosis. In the U.S., the bone-thinning disease is
responsible for 1.5 million fractures and 37,500 deaths
every year due to fracture-related complications.
The findings of the new study were from the second
portion of the Fracture Intervention Trial (FIT).
Previously, the study had found that women who did have
spinal fractures could reduce their risk of a spine, hip
or wrist fracture by 50% by taking Fosamax.
The new study included 4,432 women aged 55 to 81 who had
a low bone mineral density but no fractures due to the
bone thinning. Preliminary results from 79% of the study
participants suggest that those who took alendronate for
more than four years had 5% greater bone mineral density
in the hip and nearly 7% greater bone mineral density in
the spine as women who took a placebo or inactive
Overall, 3.5% of women taking a placebo had spinal
fractures compared with just 1.7% of those taking
The finding is important because "after women
experience a first spinal fracture, they are twice as
likely to fracture their hips and four to five times more
likely to suffer additional spinal fractures than women
who have had no spinal fracture," said study author
Dr. Steven Cummings in a statement released by the
University of California, San Francisco. The study is a
collaborative effort with researchers from Merck Research
Labs, a division of Merck & Co. Inc., the
manufacturer of Fosamax.