Roll Call: Anyone in the Phase III Trial of Bisphosphonates

Hi China--

I am on the Ibandronate arm of the trial.  I only have bloodwork done every 3 months as part of the trial.  When I saw the trial nurse last Thursday, she said that when I am finished with taking the meds in 2011, the trial group would require some tests (ie. bone scan) to check on the status of my bones.  My med onc did say that the bisphosphonates stay in your body for years after you are finished taking them.  I had questioned him about going on the regular osteoporosis dose after I completed the trial.  He seemed to think that would not be necessary for years after the trial completion.  Hmmmm...

Lorrie 

Did anybody hear the news about Fosamax on TV?  I saw a news story saying that some women get femur fractures while on it.  Would this have any impact on this study?  Just curious...

I am in it - zometa - finished 2 of 30 rounds.   Although I want this port in my arm one minute more than I have to for the regular chemo - (last one is May 3rd!!!!!), I will stay in the study for all 30.  I think it's important.

And yes, I started during chemo. 

Hi!  I've been on the Clodronate of the trial for 6 months now.  I don't have any side effects to speak of.  At first, I noticed a little acid reflux problems but that quickly went away.  When I get up in the morning I drink 2 large glasses of water and get ready for work.  By the time I'm done with the shower, etc, it's time to eat or drink something.

My creatnine level has been normal.  However, my liver enzymes have been elevating while I've been on the Clodronate.  In February, they were elevated and my onc wanted to do a CT scan.  I thought it was probably due to the pills and we took a drug holiday for about 10 days.  They tested again and my ALT/AST levels dropped back to normal.  I went back on the pills in March and they've continued to slowly climb again.  My onc wants me to stay on the study and will monitor my bloodwork every 2 months.  She said we may have to take another drug holiday to give my body a chance to recover.

Has anyone else on the Clodronate pills have a problem with their liver enzymes elevating?  

Hi 123Donna,  I've been away from this thread for awhile or I would have responded sooner.  I am in the clodronate arm too.  I started Nov of 08 and my liver enzymes have been elevated too, but my onc was not concerned.  I have lots of joint pain, but I don't know if it's from the tamoxifen or the clodronate, since I started them both at the same time.  I'm only 52 but feel like 82 with all the aches and pains I have!  I have been thinking of taking my own "drug holiday" and see if things improve!  I was wondering if you noticed any changes when you went off for 10 days?

Hello unklezwifeonty,

I am done with my first 6 monthly Zometa infusions and my next one is in 3 months. I am so glad to be done with the monthly infusions. Being on the trial is way more inconvenient than I thought it would be. I usually spend 3 hours at the Cancer Center (blood draw, awaiting results, Zometa infusion, speak with research nurse) and had to take off work.

Other than the inconvenience, I feel great. No side effects to report. How are you doing?

Hi marion and onty,  I know that you are both on this trial, so I'm hoping that you can answer a question.  I was hoping to get zometa off-label due to my "osteopenia and AI usage" (but really for the lowered recurrence risk possiblity), but now my onc says she only wants to give me aredia.  Do you know anything about aredia?  I know it's not in the trial, and I'm wondering why--I hope it's not because it's a bisphosphonate that has NOT been implicated in lowering the recurrence rates because that was why I was so excited when I first kind-of-sort-of talked my onc into considering zometa.  Now I'm really bummed about not being able to get it, and I'm really wondering how important it might be to keep pushing for it, or should I just accept the aredia and be happy with that????

Hi mmm5, I just saw your PM and read it--I'll respond to that tomorrow after I digest the stage IV of that other gal. . .

About the zometa, though, I thought you were on clondronate, not zometa.  I think part of the reasons my onc doesn't want to do it now is because she'll be retiring in december and really has to have solid evidence to back up why she is giving a stage 1, 39 year old zometa instead of the standard for osteopenia which she said is aredia.  I posted on a few other threads to try to get some research studies to take to her, but I'm thinking she will still try to say no.  I'm at Kaiser, and I think that if she was staying, she would allow me to have it, but having everything transferred over to a new onc--well, I think she doesn't really feel that it is justified enough for someone else to see.  One of the biggest problems I have, though, is I can't find very much info on aredia.  I don't know anything about it.  Why aren't any other women on it for osteopenia if that is the standard?

Dear Weety,

I do not know anything about Aredia either. The trial is for Zometa or Clodronate or Ibandronate. I believe enrollment is the trial is closed. Remember to read up the total dosage level for Zometa in the trial is higher than that given for bone use.

Hi Sanaisa,

I have had 2 zometas after finishing chemo. No issues here. I am taking D3 regularly.

I'm not on this trial, but have been following it since my onc was supposed to give me zometa off-label (don't know if she still will or not)  I read a trial recently, but don't remember where, that the effects of zometa on recurrence rates still held at 2 yrs post zometa treatments.  So, my thinking is, even a short time on zometa must give lasting results!  The trial gives a much higher dose than just what is recommended for osteo.  I understand you questioning whether to continue or not.

I am still in the Zometa trial. I have 5 Zometa IV's left now (have had 7 already).  Number 7 will be here at the end of this month.  I saw my Onc today and asked him about it...he said that while he has no opinion on it that he can offer me, he added that my being on the AI's def affects bone density and the Zometa is a bonus, if nothing more. With the Zometa, he indicates that Boniva, or any of the other oral treatments, will not be necessary.  I was found, BTW, to have "Osteopenia" after finishing chemo...at 46 years old.  The AI's don't help the cause...I plan to continue the Zometa trial.

As mentioned earlier, I dropped out of the trial. I still got to have a bone scan, paid for by the study. The research nurse also asked if they could still follow me, which I accepted.

That's very strange, sanaisa.  From what I understand, there are protocols to be followed when a participant stops the trial, for whatever reason.  I've talked to the study nurse, and she told me that the study requires participants to have a bone scan when they finish treatment - whether they finish because they drop out or because they've completed the trial.  Did she give you an explanation as to why you were dropped?

The jaw necrosis was one of the deciding factors for me on dropping out.  When I joined, I was willing to take the risk, as the benefit of reducing recurrence seemed worth it.  However, now that it looks like I wouldn't really get the benefit, the risk is now too great in my opinion.

sanaisa: I agree with you, this board is creepishly silent... I expected a lot more reactions from women on the trial after what came out of San Antonio.

Same thing happening with other boards related to fertility/periods/babies after BC. I am very interested in those topics but they are just creepishly silent too...