Roll Call: Anyone in the Phase III Trial of Bisphosphonates

Hood1980

Hi samiam,  I didn't start the study until I had completed chemo.  I had just gone to the dentist just prior to chemo so he completed the form for me.  I go every 6 months to the dentist.He did not have a problem with me going in the study.  He told me the risk is very small and that the recurrence of bc without it was greater than the risk of jaw necrosis.

sunandsandgirl

Hi Samiam,

I did not have to take chemo, but I did start the Tamoixfen at the same time.  

The research coordinator at the onc office said that I would have to pay for my dental exams.  I actually called the dentist because I was nervous about taking the biophosphates.  I had just been to the dentist as well, and he said that they would do a more extensive xray when I returned for my next appointment.   He had knowledge of the jaw necrosis side effects, but he thought it was a very minimal risk.  He thought with careful monitoring they would be able to recognize any evidence of early necrosis of the jaw, and that if I stopped the medicine (if there was necrosis) there probably would not be any permanent damage to the jaw.  He also said the same thing that Hood1980's dentist said. 

bluedasher

Has anyone gotten Clodronate recently? I got randomized to Clodronate, but the pills were on backorder and have been for a while so I couldn't start last week. If they don't come this week, next week will be more than 8 weeks since I finished chemo. I'm not sure what they will do about that since one is suppose to start this study within 8 weeks of chemo but I'm already signed up and they don't have the drug.

sunandsandgirl

I just started the Clodronate this month.  I am to go back to the onc on Friday for a refill.  It will be interesting to see if they have any.  I will let you know.

MarketingMom

Route53's wife finally here, chiming in...:)

Yes, after just picking up my next few months' worth of Clodronate pills, (like others have been told) my coordinator told me they are having supply issues and by the next batch they might be running low.  I started in early December (along with Tamoxifen and Zolodex/ovarian suppression), and so far, I'm only getting hot flashes from the latter two - e.g. no Clodronate side effects at all. I decided to take it before bedtime. They said you might have stomach issues if you don't sit upright for a bit, but I have taken even right before bed and not had any problems.  I just make sure to wait at least an hour after dinner before I consider taking it and usually take it at least a little bit before bed.

Hood1980

I went to my onc visit today.  It was my last monthly visit before to every 3 months between visits while on the clodronate.  I was hoping to get a 3 month supply but they too are running low and only gave me a one month supply.

Wink

When I heard that about the backorder of clodronate; I called my coordinator and asked if the ibandronate (Boniva) was also in short supply.  She told me that it was not - the clodronate is manufactured in England, but she did not tell me why it's in such short supply - probably something to do with the world economy.

ptjen

I received my first month's worth of clodronate yesterday. I'm waiting to start it on the weekend in case there are any side effects - nausea was one mentioned. I'm really disappointed I didn't get the Zometa. It was the research on Zometa and letrozole (Femara) that caused me to ask about taking it since I was going to be taking letrozole anyway. So when this sudy was offered, I was happy to join. I'm not so sure I want to stay on it though. It's clear this study is to compare the Zometa results to the other two drugs. I'm feeling like a guinea pig at the moment. I wasn't told there was a shortage of the clodronate. I'd hate to start it and get it interrupted.

bluedasher

I was suppose to have started 3 weeks ago but they still don't have clodronate for me.

ptjen, I read that clodronate was the control in this study because of two earlier studies that showed that clodronate showed a survival benefit.

https://www.ctsu.org/data/protocols/SWOG/S0307/ppt.pdf 

bluedasher

I went in for my Herceptin infusion yesterday and they had a big box of Clodronate for me - perhaps the supply problems are over. It contained about a 9 month supply. I had my first dose this morning.

samiam40

Well ladies, I finally signed the consent forms yesterday and should be finding out this week what arm I'm randomized into.  Good to hear about the Clonodrate having anti-recurrence properties. I'm kind of hoping for that one, since I want to be done with infusions after I finish chemo in June!

samiam40

I was told by the study coordinator that I wouldn't need a bone scan or any other kind of scan prior to beginning the study.  Has anyone else gone without?  I would have thought they would need this to have something to measure against at the study's completion.

Wink

I did not have a bone scan either; I don't think that the study is actually measuring bone density - that would have been of concern when the drug was in trial for it's original purpose (IMHO).

bluedasher

No bone scan for me either. The study doesn't call for an initial bone scan unless it's needed to rule out mets or other cancer. The study description on www.cancer.gov/clinicaltrials/SWOG-S0307 says "Patients with skeletal pain are eligible provided bone scan and/or roentgenological exam are negative for metastatic disease."

samiam40

Well wouldn't you know it, I wanted one of the oral medications, and got ramdonized into the IV Zometa group.  I start Monday and will get it along with my chemo infusion. 

Second thoughts....I have them.

Hood1980

Let us know how it went samiam40.  I hear the first dose gives you flu like symptoms but after that it goes smoothly.  I hope all is well for all the other ladies in the trial!

Hood1980

Bump

Sukiann

Samiam40, how did the Zometa go?  I'm thinking about being in the trial too so I'm interested to hear how it went.  I hope you ok.  Just when you think it ends after surgery, chemo and radiation, you have to deal with the bone stuff.  So hard! 

JustSaying

I have had 3 Zometa infusions so far on the trial. No problems at all. Just a little fever achiness after the first 2. After the third, nothing. And I had a Lupron shot on the same day of the 3rd Zometa, and still no side effects. So it's a lot better than I had anticipated. BTW, I am on Effexor which is supposed to help a lot with hot flashes/menopause side effects.

samiam40

Thanks for asking about me.  Unfortunately, I had some bad side effects after Zometa infusion.  I got it at the same time as my 4th chemo infusion, though, so I don't know whether it was the chemo, zometa or a combination of the two.  I spiked a fever of 101 on day 2 and had to spend a few days mostly in bed with aches, nausea and fatigue.  I wish I hadn't started the bisphosphenates until I was done with the chemo; then I would know for sure what is causing the side effects.  Hopefully the next one will be better!

Anonymous

     I have been getting zometa via infusion for at least 4 years ( I get fuzzy on dates, maybe it's been even longer)   and my insurance pays for it and so far as I know I have had no ill side effects. I was on pamidronate (sp) before my onco switched me to zometa and I like it better becaust it takes much less time to administer.  I did not have problems with ins paying for either drug.....probably due to the fact I had bone mets.  Why are they doing trials now?.....because of osteonecrosis?...or to see if the other med is as effective?  I have treatment tomorrow so will ask my onco when I am there since I had never heard of clonodrate.  I find it amazing all the things I learn from these message boards.  I do get very mild flu-like symptoms a few days after my treatment  ....eyes burn, BUT that has only started since I got on this abraxane/avastin combo of chemo.  I was told that I would get zometa the rest of my life and again am sure this is because of my bone mets. 

sandy2009

I will be starting Zometa this Thurs. 5/21.   This was the drug I was randomly picked to be on for the clinical trial.   Before I knew which drug I would be given, I had to have a chest x-ray, a bone scan, cat scan and my dentist sign a form.

I am hoping I won't have any SEs.  I would like the infusion to to be given slowly (longer than 15 mins. - LindaLou53 gave some wonderful information regarding this, she also stated to ask for a saline bag hooked up too - less SEs, better for kidneys).

I am also on Tamoxifen (since May 1st, no major SEs, only some minor hot flashes - so far).

Sandy

sarahsewer

Hi Ladies,

I started ibandronate in January and I have found my lower back is achy each morning. My shoulders feel tight too. But the one REALLY WEIRD side effect I experienced is the hugest bruise on earth after stopping a football with my lower leg! I had an instant purple blue mound on the inside of my ankle. SInce then I've been told ibandronate messes with your platelets. Like chemo and radiation don't, sure.

Have any other iband ladies snuck a sip of coffee before 30 minutes? I have and my oncologist was surprised I didn't get a belly ache.

Sarah

Hood1980

I'm in the clodronate arm & oh yea, I sneak a sip of coffee but not much!  ;-)

Alyad

I'm on the ibandronate arm, but I just started a few weeks ago, I haven't noticed any side effects at all. I really struggle with having to wait 30 min to eat- I tend to sleep as late as possible and rollout out of bed and grab a bite on the way out the door. I tend to wake up starving and don't want to wait to eat  either.

bluedasher

For those who sneak a sip of coffee - does it have milk or cream added? My understanding is that milk will interfere with absorbing the drug. I tend to wake up some time between 3 and 5 AM and need to use the bathroom so I take the Clodronate and my thyroid medication then and go back to sleep for a while.

I haven't noticed any side effects except I'm having mild diarrhea at times. Is anyone else having that on Clodronate?

Marybe, this trial is for women who don't have mets. They have been using these drugs for women with mets for a while based on earlier trials that showed it helped there. The question is whether these drugs will help prevent reccurrence and if one of them does it better. There have been some small studies that indicate that they help but this is a larger one and compares the three drugs where the earlier studies just used one drug.

sunandsandgirl

Hood1980

I was not instructed to quit drinking coffee.  I was told to take the clodronate in the morning with a glass of water and then stay upright for one hour.  I've been drinking coffee as soon as the hour is up. I will check with the clinical coordinator.  

bluedasher

Is anyone else having trouble with elevated creatinine? Mine was high at the end of chemo. After chemo it went down a little but it has come back up to its high point at the end of chemo. My onc called today and said she may want me to quit taking Clodronate if it doesn't come back down.

MarketingMom

I'm on my 7th month of the trial now.   Other than the Hot Flashes and the monthly OS shots, I'm okay with the side effects which have been minimal.

What I have noticed though is that I have had lots of bruise marks that show up black and blue when i don't recall bumping into anything real hard or falling.  My husband will just point out and say, "What happened there?"  They just show up for no reason.  Anyone else have this issue?

bluedasher

Marketing Mom, I don't see hot flashes as a side effect for any of the bisphosphonates. Since you are hormone positive, isn't that more likely due to whatever hormone therapy you are taking? What is a monthly OS shot? I haven't had any bruising and don't see anything related to that on the side effects lists either.

I'm on the Clodronate arm of the study.  I'm still having problems with my creatinine level staying up at the level where it was at the end of chemo. I'm not getting any definitive answers from my oncologist or my regular doc on whether that means that staying on the Clodronate is okay or might pose too much danger of more kidney damage - especially considering that I'm stage I and don't have that much potential benefit from the bisphosphonate. The PCP said I should ask the onc and the onc said I should ask the PCP - maddeningly frustrating!

I had a kidney ultrasound and they look okay except for mild thinning of the renal cortex which one doctor told me is normal for my age. 

I'm really torn. Somethings I read make it sound like any elevation of creatinine is very bad and others say my level of elevation isn't a big deal. 

I was trying to get a referral to a nephrologist (kidney specialist) but my doctor left on vacation without getting back to me on that. Yesterday I talked to the doctor covering for him and at least he agreed to send an email to one of the nephrologists to get an opinion on this.

Meanwhile, I learned that the study allows one to take a 4 week break from the Clodronate without leaving the study so I'm doing that to see if it lets my creatinine level go down. At least that way I'm not worrying about doing harm to my kidney while I wait for an answer. I'm almost 2 weeks into that so I hope they get on the ball and get me an answer before the times up.

My onc and PCP have been so good about answering questions in the past. Perhpas in this case they just don't know the answer but then they should refer me to someone who at least can give me a more educated opinion.