Roll Call: Anyone in the Phase III Trial of Bisphosphonates

Ihavehope

I only got major leg cramps when I travelled and was walking more than I was used to, I was dehydrated so water and gatorade was what I took and it helped a great deal although it took hours for it to start helping. 

Dawnbelle

My oncologist is one of the primary investigators on this trial.

I decided against the first trial she suggested, including ovary suppression/removal.

I am considering this one. I go for my scans tomorrow, I am scared of the nuclear bone scan & what it may find. Is that normal or am I just crazy?

mmm5

I am on clodranate arm and so far no problems with creatin. however I do notice problems with bruising and did not know what to attribute it to, chemo, herceptin, AI, bisphos, who knows

didle20Diane

Dawnn.....no you aren't crazy.  I was scared silly after every test they wanted to do on me.....luckily all is OK for now but jeez....enough is enough eh?

Hugs

Diane

bluedasher

They didn't do a bone scan on me. I thought that the trial only required one at the end.

Wink

I didn't have a bone scan either.

didle20Diane

It was the dexascan....but I did also have a CT Scan and Bone Scan prior to chemo which were clear.

Ihavehope

I look at the bone and CT scans as a reward for all the stuff I go through because I look forward to hearing about positive changes.  You have to think positively.  Imagine things getting better and they will.

Dawnbelle

I was put in the Zometa arm of this study & get my first infusion on Tuesday the 25th.

Has anyone had bad SE's? I have heard flu like symptoms, that Tylenol takes care of.

Any advice, besides drinking lots of water??

Ihavehope

Sorry Dawnn, I am on bonefas and I don't have any side effects related to it.  I do have side effects to my herceptin injections.  I get inflamation in my muscles and joints during my 2nd week of a 3 week cycle for herceptin.   Good luck Dawnn. 

checkum

Hi Dawn,

My 1st treatment I had the infusion in 15 minutes.. had flu symptoms fever/chills/aches all the next day.  2nd treatment slowed the infustion down to 45 minutes and life is good!

bluedasher

After agonizing about it for a couple of months, I've decided to leave the trial. I was on Clodronate and I've been worrying because I've been having elevated creatinine levels that appear to be caused by the drug - it went down when I took a 3-week break from the drug and back up when I went back on.

My oncologist and PCP weren't able to tell me what level of risk to my kidneys this posed so I got a referral to a nephrologist and met with her Friday. She felt that since I've had elevated creatinine for all my approx 3 months on clodronate, that being on it for 3 years was too risky. If I had to stay on it, then she recommended cutting down to a half dose. The risk of kidney failure is dose and duration dependent. Since my kidneys have trouble dealing with the drug, 3 years on this dose is too much risk for me.

I'm just stage I so the benefit isn't that large and risk vs benefit of the trial doesn't make sense for me.

BTW, for those on Zometa, she also mentioned that the kidney result was also dependent on infusion time when the drug is IV so longer infusion time carries less risk. Another reason to prefer a slower infusion.

I hope the rest of you do well on the trial.

Ihavehope

(hugs) Bluedasher.  I think you made the right decision for you.  If you had bone metasteses, then maybe it would be worth the risk.  For me, the clodronate is not a kidney issue but a liver issue.  I can't take pain killers on a regular basis as it is too hard on my liver.  I have learned to live with the pain and only take ibuprophen when I am very stiff from yardwork. 

Good luck Bluedasher, may Cancer be gone from your vocabulary in relation to your health. 

edited to be more specific

lilla

Wow.  This is great to find others on this trial.  I have been on the trial since April 2008.  Have has some side affects with Ibandronate, similar to the ones already mentioned, but still slugging along.  I feel my slight SE are small in the whole scheme of things.  I do have dental concerns, as I was told that the SE for dental would be for life and I have had some concerns regarding high liver enzime levels.  I am scheduled for reconstruction in January 2010....two years from my left breast mastectomy.  I will have the right breast removed and reconstruction done for both breasts at the same time. 

Wink

Welcome aboard Lilla.  I'm on ibandronate too - since Nov 2008.  My BUN & creatinine have been fine & I've had normal liver function test results.  Osteonecrosis of the jaw is scary; my coordinator said that they see it more in patients that have poor dental hygiene.  I need to schedule a regular dental check up, hopefully, bone loss will not be an issue.

2010 sounds so far away, but the reality is that it will be here before we know it!  I had bi-mast Aug 08, started reconstruction July 09, and will have my exchange surgery Sept 28, 09.  What type of reconstruction will you be having?

Ihavehope

Hi lilla and wink.  I will have a double mastectomy and reconstruction at the same time this fall.  Just awaiting my plastic surgeon's reception to call with a date.  Good luck.

Hood1980

Good Luck Ihavhope.  Have you got a date for your surgery yet?  Also - Have you been on the reconstruction threads?  There is a lot of valuable information over ther. 

Morgan513

I am also on the trial.  I started last October and am on Ibandronate.  It's really a breeze.  I think I read that some of you also on Ibandronate only wait 30 minutes before eating/drinking.  Is that true?  My doctor has me waiting 60 minutes.  It's a bummer.  I hate waiting around for an hour before I have my morning coffee!

 Lorrie

DATO

Hi all,

I've been in this study since about July 2006.  I was in the Zometa arm of the trial and I'm now done with the infusions.  I had my bone scan a couple of weeks ago.  It's amazing, I feel great, but knowing that the bone scan would find cancer if it had gone to the bones had me worried.  The results came back with no sign of cancer, but a couple of weird things did show up.  My onc said that something (I can't remember what) could have been a sign of sickle cell anemia, but I'm the wrong ethnic group for that.  There was some overgrowth of bone in my skull which could have been a sign of Paget's disease, but it I had Paget's, then a certain blood test would be elevated and my tests were all completely normal.  She said that the bone growth could be the result of the Zometa since it is designed to increase bone density.  I imagine that they are compiling the results of these scans to see the range of effects that are observed.   I never had any bad side effects from the infusions (30 minute infusions with saline) and being stage IIIa, I feel very grateful to be in the study.

Darlene

Hood1980

Thanks Darlen for the very positve feedback.  You are the first person I have heard from that has completed the clinical trial.  I'm so happy for you that you had good results.  May you be Blessed with a LONG & HEALTHY life.

Dawnbelle

I started this trial. I had bad side effects from the Zometa. I was really nauseous for almost a week. I will talk to my oncologist on the 24th when I go in, I may not do it again. I can NOT be sick like that for a week every month. I have kids & my DH is out of town a lot

They gave it to me over 15 minutes. No saline. Does this drug really have a 10 year half life?

If so, why do they give it so often?

kt57

DATO:   Are you on any bisphosphanates now?  

Wink

Lorrie - I was told to wait 30 minutes (sometimes I have my coffee after only 25).

Panchoandlefty

Lorrie-- On the trial, the Ibandronate instructions say to fast 30 minutes. 

I know some people who are on the monthly Boniva and they have to wait 60 min.  Your doctor may have given you the blanket instruction w/o carefully reading the protocol. 

 Stephanie 

holligoog

I am in the study at UNC Chapel Hill. I am in the Zometa arm and have had 2 infusions. I had nausea and body aches after the first infusion, no side effects after the second infusion. I plan on sticking with it since I had Triple-Negative and the hope is that it will prevent it from coming back in my bones.

Panchoandlefty

Ibandonate for 15 months. I guess I started April '08. 

No SEs, but I have a hard time with the fast. When enrolling, the nurses said that an "average American breakfast" whatever that means, would decrease efficacy by 70%. I don't east a big breakfast, but I d have a hard time making it the full 30 minutes w/o coffee. I worry it is decreasing the benefit. 

If I could get IV Zometa, I might drop the trial and switch. For me, I think it would be more effective since I would be more compliant. 

I'm premenopausal, so I don't know if my insurance will cover bisphosphonate therapy.

 Stephanie 

holligoog

Insurance will pay for Zometa if you are stage 3 or 4., The purpose of this study is efficacy in stage 1 & 2. If it has a positive outcome then insurance will pay. It is also trying to see if the oral meds are as effective - easier than going in for infusions. Hang in there!

Panchoandlefty

I'd SO rather have infusions. This is going to be a bit of a vent. 

I guess after chemo, IVs just don't bug me much. For someone like me, who would comply with infusions, I think that the oral meds won't be as effective because of compliance issues (eating too soon, etc). 

I REALLY want off the Ibandronate and onto Zometa.

I think part of my issue is psychological. I am on 6 different oral meds. I am a 2D6 Intermediate Metabolizer, so I have to super careful about inhibitors of Tamoxifen. I am have hypothyroidism and the pill for that has timing suggestions as well. 

My whole life seems to be in the confines of when/if I can/can't take medication. I'm sick of it. At 41, life shouldn't be like this. I take Synthyroid and Tamoxifen together (which isn't optimal) at night since I can't take them with the Boniva. At the same time, I also have to take Singular and Xyzal to minimize my chronic hives, since "real" antihisamines all inhibit Tamoxifen too much for daily use. Mid morning (12 hours from Tamoxifen),  I take a anti-fatigue drug for a sleep disorder. It is a mild inhibitor, but I can't stay awake without it. 

I never seem to remember the Calcium supplement. I don't want to take it with the fatigue med... can't take it in the morning... cant take it in the evening with the Tamoxifen/Synthyroid/Xyzal/Singular cocktail. Really, the best time to take it is mid-afternoon when I am picking the kids up from 2 different schools and shuffling everyone to-from activities. Usually, I am late and overwhelmed and forget. Then I beat myself up about it.  

Every morning, I have to take the stupid Ibandronate. First thing, EVERY day, I feel like I am having to confront the cancer. I feel like it is starting me out on the wrong foot...  On its own, it wasn't THAT big of a deal, but I have had HORRIBLE hives every morning for 3 months. We can't figure out what is causing them. I am just worn-slick. They are at their worst the first 45 minutes I am awake, but I can't take anything for them because of the Ibandronate (and b/c of the Tamoxifen).

I just want to get my coffee (brewed on a timer and already smelling so good) and to get back in bed for a while.  

I have 5 yr old twins and a 7 yr old. We have always had a sweet little morning routine where they wake up at about 6:15 and come into my bed and watch a 30 minute cartoon while I drink my coffee. When it is over, we have to get up and get ready for school. No time for coffee then. With  kids that age, it is always hectic. For about a year, I was setting my alarm for 5:45 just so I could take the Ibandronate and sit up in bed before they came down, but with the hives, I am just too tired. Now, I typically am drinking my coffee about 15 minutes after taking the pill. 

This sounds silly, but that morning coffee time with my babies is just so precious. During that time, everything seems normal and sweet. We snuggle and giggle and talk and I KNOW this stage of their lives is so short-lived. I want to enjoy it.  I 100% totally and completely HATE that cancer interrupts it. I hate that I was bald for kindergarten and I hate that I started chemo on the same day as my twins 4th birthday party.

Giving up my morning coffee should be an easy, simple thing, but I think it has become symbolic of something bigger...  I resent that I should stop. Stupid, childish and irrational but true. 

And, since I am drinking the coffee in bed, I am not getting the full benefit of the Ibandronate... I don't know how much a tablespoon of fat-free half-and-half reduces the Ibandronate, but I know it isn't good.

That said, my health is also important. I HAVE to take the Tamoxifen. I HAVE to take Synthyroid. I may have other options for bisphosphonates which don't require me to give up something so important to me. 

And, isn't that what the study is about? If oral bisphosphonates are as effective as IV? If the oral drugs lose efficacy if one is having coffee w/i 30 minutes (which a lot of people are) then the drugs will be shown to NOT be as effective. Furthermore, just as people will drop off the IV arm because they just can't deal with getting stuck, some people may drop the oral side because hey can't tolerate the fast. Maybe I am one of them. 

I just need to figure out how to get on an IV...

Thanks for letting me rant. I know I SHOULD be grateful. I actually brought the study to my physician! 

bluedasher

Panchoandlefty, I was told that I could take my synthyroid with my bisphosponate, Clodronate. Since they both had to be taken on an empty stomach, that helped. It was too hard to find two empty stomach times of the day when I could reliably take them. Maybe you could double check whether you can do that for Ibandronate.

Does the fat-free half-and-half have calcium? I recall reading that calcium in foods particularly interfered with absorption of the bisphosponate.

On days that I couldn't face the calcium pills (two big Clodronate pills a day was already hard enough for me), I would use some of the chewable Calcium supplements that are like a caramel (a bit chalky but not too bad). Maybe that would help for taking it on the go and feeling like there are fewer pills in your life. There is also a Calcium/vitamin D supplement that mixes into water.

I kind of know how you feel. I had to drop out of the study because it was making my creatinine levels too high indicating that my kidneys were stressed and it was relief to not have to fit those pills and the diarrhea that the Clodronate was causing into my life. I feel kind of guilty to feel glad about having to drop out.  I appreciate those of you who are able to keep going on this.

Part of what they will find out is what works best for compliance. I would rather of had the infusions too, but there would still be the calcium pills. 

Morgan513

Hmmm...very interesting that it seems like most only have to wait 30 minutes with Ibandronate.  I'm going to call the protocol nurse (not very helpful) and see what she has to say.  It says on the medication they give me from the study group to wait 30 minutes, but my onco was very clear that I needed to wait 60 minutes.  

I also love my coffee in the morning.  I get up really early during the week (like 5:15-5:30) so I can kill at least a half an hour in bed sitting up.  I've gotten really good at propping myself up and falling back to sleep.  LOL.  

I'll let you know what they say about the 60 minutes.  

Oh and I asked about taking supplements and things after the Ibandronate.  The doctor said that 2 hours after Ibandronate is sufficient time to wait before taking the calcium supplement or multi-vitamin.

Lorrie