$Unique_ID{BRK01395}
$Pretitle{Musculoskeletal System and Connective Tissue}
$Title{Has the New Drug Etidronate Been Approved by the FDA?}
$Subject{bones osteoporosis treatment}
$Volume{M-17}
$Log{
Management of Paget's Disease*0007801.scf}

Copyright (c) 1991   Tribune Media Services, Inc.


Has the New Drug Etidronate Been Approved by the FDA?


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QUESTION:  Recently I read about the new drug etidronate which is supposedly a
real break through in treating osteoporosis with very minimal side effects.
Our doctor seems to know nothing of this drug, but our pharmacist says with a
prescription he can order it and have it in the next day.  Could you please
advise if and when this drug was approved by the Food and Drug Administration
(FDA), and when it will be on the market?  I am sure many people are eager to
learn more about this important drug.

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ANSWER:  Your letter brings up some important points that have been included
in recent mail from other readers and so I am pleased to respond.  The
articles you have been reading about etidronate followed the publication of
two reports about new research using this medication presented in the New
England Journal of Medicine in May and July of this year.  One study was
conducted in Denmark, involved 66 patients and covered a three year period.  A
much larger study involved 429 women with postmenopausal osteoporosis was
conducted over a two year period in centers in Cincinnati, Cleveland, Atlanta,
Seattle, Honolulu, Denver and Columbus, Ohio.  A method called "intermittent
cyclic therapy" (ICT) was used in both studies.  Contrary to the thinking of
many people, bone is not a dead tissue, but a dynamic one, constantly being
torn down and rebuilt by special cells.  The osteoclasts are responsible for
tearing down old bone, with the osteoblasts working to rebuild the bone and
form new bony structures.  During most of our adult life these two processes
are pretty much in balance, but after menopause, the osteoclasts get the upper
hand, with more destruction of bone than new building.  The result is a
thinner or more porous bone, thus the name osteoporosis.  In these experiments
etidronate was given to slow down the osteoclastic activity for a period of
time (15 days), and then stopped, permitting the osteoblasts to function and
rebuild bone.  During the bone rebuilding portion of the cycle, calcium
supplements were given to help the process.  The entire cycle spanned a three
month period and then was repeated.  Both groups of researchers reported that
bone mass improved (as measured by bone density techniques) during the
therapy, and more important still, that the number of vertebral fractures (the
type that cause the formation of a "dowager's hump" or spinal curvature) was
significantly reduced in the group receiving etidronate when compared to the
control group.  Etidronate is not unknown to doctors practicing in the United
States.  It is currently marketed under the name Didronel by Norwich Eaton,
and is already approved for use in treating Paget's Disease of the bone, and
is considered safe and effective for this indication by the FDA.  However,
when a medication that has been approved for one indication, is found useful
for a new disease or indication, the manufacturer must submit evidence and
scientific data to the FDA to prove that it is an effective treatment for the
new disorder as well.  The news is that the manufacturer has submitted the
results of these two studies as well as other supportive data to the FDA at
this time and is awaiting its decision.  Just how long the process will take
is unknown, but I will be happy to let you know when it occurs.  So your
pharmacist is correct, he can order the medication now, but I would strongly
advise your physician to read these two articles before deciding to issue a
prescription, because the medication must be taken in a very precise manner to
obtain the same results as these investigations.
ÿ
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The material contained here is "FOR INFORMATION ONLY" and should not replace 
the counsel and advice of your personal physician.  Promptly consulting your 
doctor is the best path to a quick and successful resolution of any medical 
problem.
