Roll Call: Anyone in the Phase III Trial of Bisphosphonates

spinnaker

Dawn, I've been on clodronate for two weeks now and I also have an incredible thirst.  My eyes are much drier and my throat always feels dry as well.  I see the onc for my follow up at the end of this month, so I'm going to ask if this is typical or if something else is going on.  My biggest complaint is exhaustion.  I'm on tamoxifen as well, but I was on that for over a month before I started the bisphophonate trial and I didn't have the tiredness on tamoxifen alone, so I think the clodronate is the culprit. Hope it goes away soon.

Wink

I'm on the ibandronate arm - have not received notice to wait 60 minutes.  I did, however, receive a consent to have additional blood drawn to be sent out for the study.

My onc said that to date the findings have been positive in the prevention of bone & soft tissue mets.

sarahsewer

My new batch of ibandronate arrived yesterday and it does now say to wait 60 minutes. Are there any nutrition/ dietician like folk who can tell me something...

 If I wake up, drink coffee and then exercise for a half hour is my stomach then empty enough to take the pill if I wait for 60 minutes for breakfast? I usually dawdle with breakfast anyway.

Morgan513

Hi Sarah--I'm not sure that would work based on what I've read.  I asked that question early on because my thought was to take the ibandronate before lunch or mid-afternoon when my stomach was clearly empty .  But...they discouraged that and got me to take it first thing in the morning.  Just to say, I am a huge coffee drinker and I was NOT happy at the thought of having to wait for my first cup.  But, I figured out a routine that I've gotten used to.  I keep a bottle of water on my nightstand with a pill ready to go.  I get up a little bit earlier, prop myself up in bed and take the pill.  I then read, browse my iPod or watch TV and basically waste the hour.  I find that I can now prop myself up and fall back to sleep without laying down!  LOL.  If I come downstairs, I WANT MY COFFEE so, I try my best to waste the hour still in bed.  

It's so worth it to take it but, geez, it's tough for coffee lovers!

Lorrie 

sarahsewer

Um, Lorrie, I think I'll call the drug study nurse to plead my case. In our house we call it "shopping for answers". I'd even drink my coffee black!

unklezwifeonty

Dear Lorrie, All,

Wondering what you have heard about the benefits of bisphosphonates. From what I have heard the benefit is reducing bone mets chances and of course helping with bone density issues. There is also a belief that they help with mets in general. Is that something you guys have heard? Is that a reasonable assumption? Do you feel the risk of ONJ is worth taking?

Morgan513

Hi Unkelzwifeonty--

I had long conversations with my onc and my dentist regarding the ONJ issue.  The onc's office assured me that ONJ is a rarer side effect.  They said that they did have a few invdividuals get ONJ but that they were older, in poorer health and had generally poorer dental health.  The onc assured me that if a problem arose, they would stop the bisphosphonate for a little while.  He said that the reason that ONJ occurs is because the blood vessels that feed the bones of the jaw stop while you are on the Bisphosphonates.  He said that once you stop taking the bisphosphonates, the blood flow will begin again.  He said that they would do everything in their power to keep it from happening.  Also, my dentist has acquainted himself thoroughly with the in's and out's of bisphosphonates and ONJ.  He is extremely conscientious with me and is very cautious about my dental work.  

I feel pretty good about the situation.  For me, the pro's outweigh the con's.  So, I'll cross any bridge that I have to--if I ever have too.

Lorrie 

bluedasher

They think that the bisphosphonates may help against mets in general, not just bone mets. I read one theory that cancer cells may sometimes hang out in the bone for a while and than take hold as mets elsewhere. The bisphosphonate makes the bones an unfriendly place for them.

One good thing about being on bisphosphonates was that I followed my dentist's advice to be extra good about dental hygiene. ONJ usually happens as a complication of dental surgery so one wants to keep one's teeth as healthy as possible to avoid that while taking bisphosphonates. The ADA also has recommendations for dentists to follow if a procedure is needed while on bisphosphonates because they need to be extra careful about keeping everything sterile.

Anonymous

I am not in the Phase III trial but have convinced my onc and am taking Zometa infustion every 6 months for 2 years.  The study was just too compelling so I want to try every thing to keep from going into bone mets.  Had my first infusion today.  Had the nurse time the infusion 30 minutes instead of 15 minutes.  Anyone else got any helpful hints?

unklezwifeonty

Dear Aug242007,

Are you getting Zometa infusion WITHOUT participating in the trial? Does your insurance cover this? I am curious to know because my oncologist is not participating in the SWOG 0307 trial. But if I can persuade her to give me Zometa infusions and my insurance to pay for it, I may be game. Still not sure of the ONJ thingy.

mkl48

Why only for pre-meno women when post meno- ER+ would have an even greater exposure to bone instability or loss?? Ruth

Morgan513

Ruth--The trial isn't to test the bisphosphonates for bone health for osteoporosis prevention, it's to test for the optimal dose to protect from bone mets.  I don't believe that the study is for pre-meno women either.  It's for everyone 18 or older.  I'm post menopausal now after chemo.  

For me, the reason to do it was to prevent bone mets, hopefully prevent soft tissue mets and to prevent osteoporosis.  Not only am I on the early side of menopause but my mother had extreme osteoporosis which ultimately led to her health problems and early death.

Lorrie 

unklezwifeonty

Anyone know how to get insurance to pay for Bisphosphonates without joining the trial? And which Bisphosphonate would be best?

didle20Diane

I was told the trial was to see if the oral drugs are as effective as the infusion.  This is the 3rd or 4th phase of the trial...As for the jaw issues, the 2 people that had the necrosis occur out of over 1800 were not caused by the trial drugs.

unklezwifeonty

Thanks Diane, 2 cases of ONJ out of 1800 is worth the risk......I somehow was under the impression the risk was higher.

Morgan513

Hi Onty--Talk to your onc about getting on bisphosphonates.  I'm sure there is some way to get it covered by insurance.  

Good luck!  

Lorrie 

unklezwifeonty

Hi Lorrie,

Will do. I'm already on ECOG 5103. I shall ask her about bisphosphonates and whether I should take them now or after chemo.

bluedasher

Didie, I read that the Clodronate was considered the control in the study because there is already another study where it reduced recurrence by 30% (though I think there is another study where it didn't appear to have much effect).

Onty, until the trial is done, we won't know which is best. Clodronate isn't an approved drug in the US so you probably can't get that. Zometa seems to be the most common for people to get outside the study. Some have gotten insurance to cover it to protect their bones from osteoporosis.

unklezwifeonty

Thanks Bluedasher!

Morgan513

Yes, I think Zometa would be the one they would give you, Onty.  

Yes, clodronate is the control.  

It still bugs me having to wait an hour to have my coffee!  LOL.   

Lorrie 

unklezwifeonty

Lorrie,

Which one are you getting and how (IV or oral) and how often?

TexasRose

I signed the consent for this trial on Tuesday and just got the news that I'm in the Zometa arm. I am so happy as that is the arm I really wanted. I don't mind the infusions but I would mind the fasting with the pills. I'm sure I would have gotten used to it, but happy that I don't have to.  My first infusion is next Friday. I hope the side effects are minimal.

Morgan513

Hi!  I'm on ibandronate pills--once a day everyday.  I have to take the pill first things in the morning on an empty stomach.

I have to chuckle.  When I went into the trial, I was hoping I would not get Zometa because I had had it with infusions.  Done with it!  But now...I think I could deal a lot better with occasional 15 minute infusions instead of the daily drag of the pills. 

I'm really not complaining, taking the ibandronate is no big deal!

Lorrie 

unklezwifeonty

Mary,

I'm also TN like you, am in ECO 5103 and want to enroll in SWOG 0307 also. How cool is that! Would you be keeping the port for zometa?

TexasRose

Lorrie- When I said I was hoping for the Zometa everybody thought I was insane!! I'm not a good pill taker though.

Onty- No, my port is coming out next Wednesday. Supposed to be Monday, but they had to reschedule. It is uncomfortable and sometimes painful. I am so ready for it to be gone. It's in a horrible place - low on the inside of my right breast almost to the scarline from my left mastectomy. I have a very love/hate relationship with it. Loved it for labs and chemo but hate it all the rest of the time. I asked my trial nurse if I had it taken out could I still do Zometa using my veins if I got that arm. She said that was no problem, so the port is out of here!!

unklezwifeonty

I wonder how many triple negatives are getting bisphosphonates besides Mary and Morgan. Also how many are pre-menopausal.

I see several women taking bisphosphonates, I'm on the fence on their usefulness for me. A friend of mine in oncology research told me today that for pre-menopausal women who are triple negative and have good bones, bisphosphonates may not add much value. I was also told something similar by an oncologist who said that she would have recommended bisphosphonates to me to if I was going to get hormonal therapy but not otherwise.

Anyone care to educate me here?

unklezwifeonty

Dear Mary,

Good luck with port removal. I'm told it is fairly straightforward. Ask them to let you take it home with you if you like.

TexasRose

Onty- I'm post-menopausal.

They told me they had one lady who made a necklace out of hers. I told them I was going to smash mine with a sledgehammer.

unklezwifeonty

I  hear ya Mary .... do what you got to do ....lol

azdiva

Well, I decided to press my onc about getting me into this trial.  There appears to be only one doctor in town that works on it.  Do they have to work together?  Hmmmm . . . hope they at least like eachother.  

Does that even matter?  I wonder if I can be put in the trial without going through my onc?  Has anyone ever done this?  I don't know why I'm even worried about this, but it sort of feels like I'm cheating on my doctor, whom I do like very much.  And I don't even know if he would be opposed to it yet.  He just told me that Zometa was not the standard of care for my circumstance.  We didn't even talk about the trial.

Just thinking out loud, but if you all have any insight, it is much appreciated!

Laura