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Topic: Talk to your dentist regarding drugs for bones

Forum: Clinical Trials, Research News, Podcasts, and Study Results —

Share your research articles, interpretations and experiences here. Let us know how these studies affect you and your decisions.

Posted on: Jun 26, 2007 10:05AM

cp418 wrote:

http://medicalnewstoday.com/medicalnews.php?newsid=75307 Log in to post a reply

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Jun 26, 2007 04:11PM Rosemary44 wrote:

What an informative article. Right on point for us taking those drugs:

"In addition, there is a new screening tool now available that can help patients who have been taking an oral bisphosphonate for more than three years to determine if they are at risk of developing osteonecrosis of the jaw. It is a laboratory test called the CTX (C-Telopeptide) which measures the osteoclastic activity. If the results come back above 150 pg/ml, then it is deemed safe to proceed with a tooth extraction or oral surgery."

That is such good news to know they have a test before having the dental work done.
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Jun 26, 2007 05:05PM joanne_elizabeth wrote:

They want to put me in a trial of these drugs to see if it helps prevent bone metastases. I don't know these drugs sound a bit scary. May I ask why you were prescribed them?
Thanks,
Joanne
Joanne_elizabeth
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Jun 27, 2007 07:44AM saluki wrote:

Joanne --I was put on Fosamax initially because I had a massive shoulder break (or should I say many breaks).

The orthopedists were convinced it was due to brittle bones from Chemo. They replaced the shoulder because it was too badly injured, and they put me on Fosamax.

When I got out of the hospital. My oncologist put me on Femara.

I also had a baseline Dexa Scan that
showed osteopenia. So, considering that Femara may contribute to bone loss the Doctors decided to keep me on it.

I have since had a followup Dexa that continues to show osteopenia so for the time being they have decided to keep me on the bisphosphonate and will re-eval the situation in another year.

By the way----between long term chemo-brain, the Femara and being estrogen deprived; My memory, and attention span are nil-----So they switched me to Boniva so I would only have to remember once a month instead of weekly which I always missed.

And yes one of the reasons I am willing to keep taking it is in hopes of it preventing bone mets.

Susie
Susie, member since Jan. 2003 Dx 12/12/2002, IDC, 2cm, Stage IIB, 0/1 nodes, ER+/PR+, HER2-
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Jun 27, 2007 07:55AM saluki wrote:

Quote:
What an informative article. Right on point for us

That is such good news to know they have a test before having the dental work done.



taking those drugs:

"In addition, there is a new screening tool now available that can help patients who have been taking an oral bisphosphonate for more than three years to determine if they are at risk of developing osteonecrosis of the jaw. It is a laboratory test called the CTX (C-Telopeptide) which measures the osteoclastic activity. If the results come back above 150 pg/ml, then it is deemed safe to proceed with a tooth extraction or oral surgery."
That is such good news to know they have a test before having the dental work done.



Gosh Rosemary,
My oral surgeons office was so concerned that I signed pages of Bisphosphonate acknowledgment forms.
I wonder how the surgeon would have reacted had I asked for that test.
A little late for me since I had the extraction last week.
Susie, member since Jan. 2003 Dx 12/12/2002, IDC, 2cm, Stage IIB, 0/1 nodes, ER+/PR+, HER2-
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Jun 27, 2007 08:48AM saluki wrote:

Thank you Jlong,
I will be printing this out and taking it to all my Doctors.
One thing these last years have taught me is to never assume.

In this case meaning to never assume your Doctor is aware of
anything---No one has enough time to keep abreast of the latest
news and practice full time. In my situation what you have posted will impact on both my medical and dental care.

Thanks again,
Susie
Susie, member since Jan. 2003 Dx 12/12/2002, IDC, 2cm, Stage IIB, 0/1 nodes, ER+/PR+, HER2-
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Jun 27, 2007 11:12AM cp418 wrote:

saluki - Yes, I feel the same way where sometimes doctors are not aware of the latest news, tests, treatments, etc. It is in our best interests to stay informed and ask questions to stay healthy. Best wishes, Joann

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Jun 27, 2007 03:06PM JerseyGemini wrote:

I squeezed in an emergency dental exam/cleaning the day before I started my biphosphonate and talked to the dentist about it. My onc. didn't mention it though...if i wasn't addicted to the internet I don't know how i would know these things :-)

tess
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Jun 27, 2007 08:44PM Rosemary44 wrote:

JoAnne,

I take Actonel because I failed my dexa scan even before starting Arimidex. It's been holding steady over the years, but no improvement. I don't exercise enough either.

If you decide to do the trial, have they filled you in on the jawbone necrosis problem? And seeing a dentist first and getting any work done that needs it? How long is the trial for? I know, it's a hard decision to make.
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Jun 27, 2007 08:55PM Rosemary44 wrote:

Good grief Susie, have you ever been through the doors! Broke your shoulder? Why is it, we have to find out about these tests before the Dr.s do? Unreal.

In my case, I took the actonel before there was anything out there about jawbone death. When that news came out, first thought...doomed.

Geez, you've been through a lot. And now the tooth problem on top of it all. I give you credit, your here keeping us well informed. Thanks and please feel better.
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Jun 28, 2007 02:34PM AlaskaAngel wrote:

Thanks for the link posted earlier. I'd like to get some feedback with your impressions about the clinical trial some are considering. It may be a trial that is truly important and needed so I'm hoping that your responses will give that serious consideration too. I'm genuinely trying to figure out whether the trial, despite some drawbacks, is worthy.

Here's my concerns:

The incidence of osteonecrosis of the jaw in those taking bisphosphonates is less than 8% in studies so far, but the study involves the use of IV bisphosphonates rather than oral I think? The dose IV is massively greater than the oral dose and is of more recent use than the older oral bisphosphonates, so I don't know that the new trial really recognizes that the percentage of necrosis risk from studies done earlier may not be the same at all. So that would be one thing to ask about. One thing that seems clear from the studies that have been done so far is that the longer the use of a bisphosphonate or the bigger the dose, the more cases of osteonecrosis of the jaw that there are.

Part of the question I have about this trial is based on the fact that bisphosphonates are permanent in the body. I would guess that every person entering the study is advised to have any need for extractions or root canals done prior to entering the study since those seem to be triggers for the development of osteonecrosis. But the study is being done with NED people and if somewhere down the road during the study (or even long after the study) you need extraction or a root canal, stopping the bisphosphonate and then having the procedure doesn't mean that the accumulated bisphosphonate won't cause osteonecrosis. So... it is a very different thing to be taking IV bisphosphonates for an established need, such as significant osteopenia/osteoporosis or known mets, versus taking such drugs as someone who has good bones and is NED.

I also wonder how relevant the trial results will be if the adjuvant group that is enrolled is more unlikely to ever have mets (much less bony mets)?

If I were doing the trial, for sure I'd be asking about the test mentioned in the link earlier here, to get some idea what my risk is.

As I understand it, less than 50% of those who ever do have mets would even ever have bony mets. Yet this trial will expose thousands of adjuvants to the bisphosphonates.

I probably just need to understand better why the people behind this trial are willing to expose the thousands of early stage NED women being recruited for it to what seems to me to be such relatively high risk. I could understand a little better maybe if this trial were being done with those who already have a legitimate reason for doing the bisphosphonates.

Thanks for any comments. It would be nice if an experienced news reporter would ask some of these questions of the researchers conducting this trial for us.

AlaskaAngel
Dx 12/3/2001, DCIS/IDC, Left, 1cm, Stage IA, Grade 3, 0/1 nodes, ER+/PR+, HER2+ (IHC) Surgery 1/3/2002 Lumpectomy: Left; Lymph node removal: Left, Sentinel Chemotherapy 3/12/2002 Adriamycin (doxorubicin), Cytoxan (cyclophosphamide), Fluorouracil (5-fluorouracil, 5-FU, Adrucil) Radiation Therapy 9/10/2002 Breast Hormonal Therapy 11/15/2002 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)
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Jun 28, 2007 05:43PM Rosemary44 wrote:

Alaska,

It's really hard to reply to your thoughts cause we'd need to see the trial objectives and what type of method they plan to use to deliver the med. I.V., oral? Are they looking for a particular type of BC survivor, one that has a better chance for bone mets, or just any type of survivor?

I just read a story about a Dr. doing a vitamin D study and she's keeping people from getting D as part of the study. I'm still shocked that doing something like that can be part of a study, or allowed. They already know how serious it can be to withhold D they don't have to study it again. They really do need to be watched.
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Jun 28, 2007 07:05PM saluki wrote:

Well, Joanne and Rosemary----Thats the end of Boniva for me for at least for the forseeable future. Turns out they may have to do more surgery to close the whole in my sinuses.

Knowing the bisphosphonate situation the surgeon wants to give it more time to heal on its own. But thanks to you guys I printed out the info from the initial post.

I'm more relieved because the surgeon is putting off any further surgery and knew about the test. In fact, he thought it was a very good idea and wants it done right away before he has to make any more decisions.

So I'm to get the CTX (C-Telopeptide) and stop the Boniva till further notice. He'll give it another month to try to heal and ten days more of additional antibiotics because of the situation.---by that time the results should be back from the test and we'll decide how to go from there.

In the mean time its very weird to take my meds and have all the water come running out my nose. But I am greatly relieved that this oral surgeon knew about the blood test and is handling me with a great amount of care. Thanks again for bringing the test to light------You gals are great!

Susie
Susie, member since Jan. 2003 Dx 12/12/2002, IDC, 2cm, Stage IIB, 0/1 nodes, ER+/PR+, HER2-
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Jun 29, 2007 09:37AM AlaskaAngel wrote:

Rosemary,

It appears trial participants are the general group of adjuvants, and that the drugs used are IV:

http://www.cancer.gov/ncicancerbulletin/NCI_Cancer_Bulletin_051507/page8?cb_email=1

I still have to question the need for this trial. Why aren't they simply studying the effect using women who are prescribed the drug to begin with, rather than those who are not? Maybe they think it is more likely to prevent mets if the women have healthy bones to begin with... but if it generally takes 3 years of bisphonate use for problems to crop up (?), considering that IV use is higher risk... Please, please convince me that the results from the Phase I and II are good enough that this Phase III trial is not going to do significant harm to NED bc survivors.... Am I just too simple-minded to understand?

AlaskaAngel
Dx 12/3/2001, DCIS/IDC, Left, 1cm, Stage IA, Grade 3, 0/1 nodes, ER+/PR+, HER2+ (IHC) Surgery 1/3/2002 Lumpectomy: Left; Lymph node removal: Left, Sentinel Chemotherapy 3/12/2002 Adriamycin (doxorubicin), Cytoxan (cyclophosphamide), Fluorouracil (5-fluorouracil, 5-FU, Adrucil) Radiation Therapy 9/10/2002 Breast Hormonal Therapy 11/15/2002 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)
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Jun 29, 2007 10:41AM saluki wrote:

Alaska, I posted this somewhere before. I think you may want to read it. I also was looking for a live discussion between
Two very well known Doctor's ONE from MSKCC, the other from Dana Farber and one researcher (Budzar- From MD Anderson).

They were talking about AI's. But toward the end of the conversation There was a rift about the use and risks of Bisphisphonates----and I think it was Sloane that was backing away from using them so automatically in the adjuvent setting unless you had osteoporosis----They were not considering osteopenia as a disease.

I can only go from memory as the thread seems to have dissappeared. Its ashame----
but I did find this post that will probably dissappear forever in the next few weeks---(Don't mind me- I'm perpetually frustrated.) Before I post any info here now, I
scrapbook it.
--------------------------------------------------------
Talk about snippets--I've been reading about some suspicions
regarding bisphosphonates that frankly, I was clueless about.

Oh yes I was aware of the jaw necrosis but what threw me was a suspicion that meds such as Fosamax may actually make some even more suseptable to fractures by oversupressing bone turnover.
"The drugs incorporate into the bone and, over time, accumulate. That could make the bone rigid and more likely to break, theoretically speaking."
This is the third time I've read it and all three times it was a snippet. The last time being in of all places More magazine.

http://www.more.com/more/story.jsp?catre...47448787662.xml


Susie
Susie, member since Jan. 2003 Dx 12/12/2002, IDC, 2cm, Stage IIB, 0/1 nodes, ER+/PR+, HER2-
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Jun 29, 2007 06:09PM KarenO wrote:

I've been asked to participate in this study as well and have been going back and forth on whether to do so or not. I really appreciate the relevant posts in this thread and would be interested from hearing from anyone else who faced this decision, what choice they made (and why) and how it is going for those participating.

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Jul 2, 2007 04:44AM Rosemary44 wrote:

In this day and age, they don't know who is more prone to get bone mets?

"Additionally, we hope to determine which types of breast cancer preferentially metastasize to bone," Dr. Gralow added."

That tells me there is no follow up of any kind going on out there. There should be a registry of who has what and gets what after an initial diagnoses. And how long it takes to get what.

Plus, I don't see any warnings, things that we know that are going on and are real, where are they?

I can only speak for myself, and after what I've read about jaw necrosis and how painful and dibilatating that is, I couldn't sign up for this study.

I possibly could sign up if I knew that I had a better chance of getting bone mets, I would want to do what I could do to keep that away, but they don't seem to know who is more prone to them.

This kind of research should be for the ladies whose cancer usually do go into bone mets and they don't already know that?
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Jul 2, 2007 09:04AM AlaskaAngel wrote:

Saluki Susie, Rosemary, Joanne...

Well, now we are getting into some interesting things, although I hope we don't get sidetracked from the bisphosphonate discussion. Maybe we need to start a separate discussion for the issue of tracking cancer patients and I'm all for that. The key problems with tracking are privacy and practicality, but given the magnitude of useful info that we would get if we could get past those problems it still seems worthwhile to try...

Anyway, back to bisphosphonates.... Susie I saw the same discussion between oncs online. Practitioners waffle a bit about defining the difference between osteopenia and osteoporosis and some confuse them and prescribe anyway. The best practitioners only prescribe bisphosphonates when enough is going on with the patient that vitamin D, calcium, magnesium, etc. is not enough. And the best docs avoid IV use and use IV ONLY when something else is going on, like the patient whose stomach or throat can't handle the lower-dose pill. (PLUS, the best docs consistently track the patient's DEXA results, and they don't prescribe the IV dose any longer than they absolutely have to.)

The IV dose is much greater than the pill dose. I don't know what dose is being used for the IV dose in the trial. The common IV dose is given every 3 months whereas the pill is a weekly pill, so I think the standard IV dose in non-trial patients is larger partly because of that.

The question of whether the bone actually becomes more likely to fracture if it is too rigid is also interesting so thanks for that input.

AlaskaAngel
Dx 12/3/2001, DCIS/IDC, Left, 1cm, Stage IA, Grade 3, 0/1 nodes, ER+/PR+, HER2+ (IHC) Surgery 1/3/2002 Lumpectomy: Left; Lymph node removal: Left, Sentinel Chemotherapy 3/12/2002 Adriamycin (doxorubicin), Cytoxan (cyclophosphamide), Fluorouracil (5-fluorouracil, 5-FU, Adrucil) Radiation Therapy 9/10/2002 Breast Hormonal Therapy 11/15/2002 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)
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Jul 2, 2007 09:35AM Rosemary44 wrote:

I've read a stat that floored me. Something like 96% of Dr.s are on the big pharma dole-out for prescribing certain drugs.

I go to my PCP, and there's an ad for HRT's. My cardio is advertising zetia everywhere, my Onc has everything Femara all around. I haven't been to my GYN in awhile, so I don't know his latest advertisement.

Is there too many prescriptions for bisphosphonates, I can't say but if I'm on it, you can believe it's the latest pharma dole-out pill. My Onc gave me the prescription for a osteopenia dx, but knowing the havoc of having less estrogen, I decided to take it. He could have said, you need to go on calcium, etc, get exercise and see what happens with the next dexa scan. Maybe had a hand-out of advice for bone health. Instead, he reached immediately for the prescription pad with no advice of any kind.

I can't say how bad my bones would have gotten without Actonel, I've been on it as long as I've been on Arimidex. But are they jumping with pad in hand to prescribe too quickly, probably.
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Jul 2, 2007 10:03PM biondi wrote:

rosemary, i conmpletely agree with you. my pcp wanted to start me on actenol one yr ago. i refused and told her i had not yet been dx'd with osteoporosis, and that i was having dental work done. (she hadn't mentioned the se's of the bisphosphonatel). NOVARTIS, who is pharma that produces FFEMARA, knows that this drug hurt our bones, soo, they have come out with a one a year IV'bisphosphonate, you see, they have to keep the ball rolling..next they will come out with a artifical jaw replacement as a result of "dead jaw". or osteonecrosis..caused more frequently from the IV bisphosphnate!! $$$ i will do everything i can, exercise, diet,vitamins to control my osteopedia..
also, consider STRONTIUM as a dietary supplement. been used in europe for years as a bone builder, not approved in US. BY FDA--DUH..available in the U.S. however, as STRONTIUM CITRATE. and i am going to start on that soon. it's a natural occurring mineral in bones.
www.drbvitamins.com & GOOGLE has lots of sites about it..
thanks for sharing info, it's important to all of us, and helps us to make more informed decisions about our course of TX. HUGGS TO ALL YOU LOVELY LADIES.
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Jul 3, 2007 04:49AM joanne_elizabeth wrote:

Hi again,
The trial they offered me had 3 types of bisphonphanates, only 1 was IV, the second was in abnormally high doses, the third I believe typical. So far I am afraid to join.
I agree, in this day and age they can't tell who has bc half the time and have no clue who is at highest risk for metastases. Where is the progress?
Joanne
Joanne_elizabeth
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Jul 3, 2007 05:45AM saluki wrote:

Quote:
In this day and age, they don't know who is more prone to get bone mets?

"Additionally, we hope to determine which types of breast cancer preferentially metastasize to bone," Dr. Gralow added."

That tells me there is no follow up of any kind going on out there. There should be a registry of who has what and gets what after an initial diagnoses. And how long it takes to get what.

Plus, I don't see any warnings, things that we know that are going on and are real, where are they?

I can only speak for myself, and after what I've read about jaw necrosis and how painful and dibilatating that is, I couldn't sign up for this study.





Does anyone warn you --aside from the danger of osteonecrosis of the jaw; ------of the very real possibility of kidney toxicity when getting these IV?..........

Personally, I think that is a very real concern.

When you have bone mets you wind up weighing risks vs benefits; You really don't have the luxury to not take the risk, so its a matter of monitoring you very closely.

But, since this is essentially a prophylactic move with no really long term results I think I'd pass as well.

I think we are guinea pigs enough, with the Femara (also courtesey of Novartis) Arimadex and Aromasin.
Susie, member since Jan. 2003 Dx 12/12/2002, IDC, 2cm, Stage IIB, 0/1 nodes, ER+/PR+, HER2-
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Jul 3, 2007 09:29PM biondi wrote:

BE SURE AND GO SEE, MICHAEL MOORE'S "SICKO" REALLY A TRUTHFUL AND HUMEROUS LOOK AT "BIG PHARMA. ACTUALLY, FRANCE HAS THE #ONE HEALTH CARE SYSTEM. IT'S ABOUT HMO'S ,INSURANCE COMPANIES GONE AMUCK, A MUST SEE! HOW CAN A PERSON PAY $300.00 PER MONTH FOR ONE DRUG, FOR EXAMPLE, FEMARA..NO WONDER THEIR PUSHING IT! TIME FOR CHANGE, FOR SURE..

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Jul 4, 2007 07:16AM LizM wrote:

Interesting thread ladies, I have been on Arimidex for a year and had my first bone density scan in May. Results came back on the high end of osteopena. My pcp immediately put me on Fosomax with D3. I have been taking it for approximately a month. I have not discussed it with my oncologist but will at my follow-up appt in two weeks. This may seem strange but for some reason I was secretly hoping my bone density scan would cause me to go on bisphosphonates because I had read about the thought these drugs may possibly prevent bone mets. When my pcp mentioned fosomax/d I didn't put up an argument because I thought I would be killing two birds with one stone - preventing osteoporosis and possible bone mets. Now after reading this thread I wonder if it is such a good idea. However, I was doing everything right before my bone density scan. I walk briskly on the treadmil or outside for 2 miles every day and have for almost two years since my diagnosis. I take my calcium and vitamin D. I had my vitamin d levels checked and they were OK. It is either the Arimidex or chemo or the fact that I only weight 115 lbs and am 5'6" but I am afraid of getting osteoporosis. If I had been asked to be in the clinical trial I probably would have accepted.

Dx 9/19/2005, IDC, 2cm, Stage II, Grade 1, 1/8 nodes, ER+/PR+, HER2-
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Jul 4, 2007 12:05PM maxgirl wrote:

I've been asked to be in the trial, and since I'm a triple negative, it sounded like a good idea to try something that might prevent bone mets.

Then I started reading up on the SEs, and I've changed my mind. I've had extensive dental work in the past, and I'm sure more will be coming, and I don't want to fool with osteonecrosis of the jaw.

Also, I can't even take a multivitamin without getting stomach pains, and except for the IV form, these drugs are hard on the stomach.

One thing to remember about statistics such as "only 8% of patients have been found to suffer from this side effect" is that number applies to a large group of people, not any particular person individually. So my individual chance, because of whatever history I have, might be much higher.

If I end up having to take bisphosphonates for mets, so be it, but I'm not going to take them because they "might" prevent mets.
Dx 1/10/2007, IDC, Stage IIA, Grade 3, 2/15 nodes, ER-/PR-, HER2-
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Jul 4, 2007 03:48PM AlaskaAngel wrote:

To Liz: If you are getting Fosamax (pills) you are not getting the megadose that one gets with IV, and in no way do I mean to imply that it is not useful if you have osteopenia. However, they don't know for sure yet how long women should take it and it may be a good idea to take a break eventually, or at least have the test done.

To ALL: One problem with believing the problem occurs in less than 8% is that, as mentioned previously, bisphosphonates can be upsetting to the stomach, especially if they are not taken according to instructions, but sometimes even if they are taken according to instructions. This usually means that a fair number of patients will get the prescription but not take the drug at all or only haphazardly, which would then mean the 8% is very likely understated.

Another problem is that much of the documented history of use of these drugs is based on use in metastatic patients, since it was used for them first. Sad to say, many of the patients with mets did not live long so there are less long-term results for them, and extended use of bisphosphonates would also then be understated. Bisphosphonates do not have a long history of use yet, partly because the AI's like Femara and Arimidex and Aromasin that can contribute to bone density loss haven't been around that long either. (Just 5 years ago, Arimidex was the only approved AI available.)

Thus the 8% may be an understatement.

AlaskaAngel
Dx 12/3/2001, DCIS/IDC, Left, 1cm, Stage IA, Grade 3, 0/1 nodes, ER+/PR+, HER2+ (IHC) Surgery 1/3/2002 Lumpectomy: Left; Lymph node removal: Left, Sentinel Chemotherapy 3/12/2002 Adriamycin (doxorubicin), Cytoxan (cyclophosphamide), Fluorouracil (5-fluorouracil, 5-FU, Adrucil) Radiation Therapy 9/10/2002 Breast Hormonal Therapy 11/15/2002 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone)
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Jul 4, 2007 07:26PM biondi wrote:

DR. WEIL TALKS ABOUT BONE BOSTERS--BISPHOSPHNATES- VERY INFORMATIVE ARTICLE..

http://www.drweil.com/drw/u/id/QAA400139
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Jul 7, 2007 11:40AM maxgirl wrote:

The Kaiser research nurse for the bisphosphonate study left a message for me yesterday about signing up for the trial, and one of the things she said was, "They're finding that bisphosphonates prevent bone metastases." Now, while not entirely false, this is certainly not true either. I scoured the Internet last night to see if any new studies had shown up and found only the same 3 -- all small studies, with contradictory findings. In fact, one of them found that triple negs on the IV form had a much poorer overall survival. That doesn't prove anything either -- the studies were too small to say anything conclusively. I wonder how many people she's luring in with that kind of misrepresentation.

Dx 1/10/2007, IDC, Stage IIA, Grade 3, 2/15 nodes, ER-/PR-, HER2-
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Jul 9, 2007 07:13AM cp418 wrote:

I've recently come across articles regarding the role of Vitamin K in bone health for Calcium and Vitamin D3 to work together. See another link below.

http://lpi.oregonstate.edu/infocenter/vitamins/vitaminK/

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