<<Disclaimer: Verify this information before applying it to your situation.>>

Response to Fosamax trial in paper:



Fosamax recently published a 10 yr trial on the drug, measuring BMD.
BMD, also known as bone mineral density is one way of measuring if a
drug is working for the treatment of osteoporosis.  Other tests include
bone turnover markers (simple blood tests) and bone biopsies (painful).



Even if your BMD does not improve with your current drug, it does not
mean that your drug is not working.  The ultimate question is, have you
experienced no fractures?



The primary endpoint that the FDA looks at for the effectiveness of a
drug used to treat osteoporosis is FRACTURE



The ideal goal in treating osteoporosis is to prevent fractures.



This study looked at BMD, not fracture, as an endpoint.  About 30% of
all fracture reductions can be attributed back to BMD, that is why this
study is seen as positive.



Other products can build a little, or a lot of BMD.



Fluoride, for example, can build a tremendous amount of BMD, however the
QUALITY of the bone being built is like chalk-- that is why it is not
indicated in the US for treatment of osteoporosis.



Fosamax does have 3 year fracture data for the spine and hip, however
they did not carry the fracture arm of the study out for  analysis--
only the BMD portion.



Other drugs on the market:  Actonel:  has 1, 3,5 and soon to be
published 6-7 year fracture data.  It also has 3 year hip data.  It is
in the same class as Fosamax, and has much better tolerability-- less
heartburn, stomach upset, dypepsia, etc. Both it and Fosamax can be
given weekly.



Miacalcin has 3,5 year spine data, although there are many questions
regarding the study design and the results.  It is a nasal spray,
biggest side effects are nose bleeds, and inconvnience of dosing.



Evista has 3 year spine data, but no hip data.  Side effects include hot
flushes, leg cramps, and very serious DVTs.  It is taken daily and is
more expensive than the 3 listed above.



Forteo (expensive) has 21 month data, but no hip data. This is seen
right now as the product of last resort, when you can't take anything
else.  It is an injection given daily, is VERY EXPENSIVE ($7000 a year).
It is a good medicine, but is a 'biological' drug- meaning it comes from
genetically re-engineering DNA-- therefore, the price tag.



BY NO MEANS IS THIS AN ENDORSEMENT OF ANY PARTICULAR PRODUCT, PLEASE
CONSULT WITH YOUR PHYSICIAN BEFORE MAKING ANY CHANGES TO WHAT YOU ARE
DOING





Kim P.

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