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    Old 05-03-2007, 07:22 PM   #1
    montesflus
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    New Osteo Drug Under Review

    I heard on the BBC news this evening and also on one of the local news broadcasts in Los Angeles, that a NEW, once yearly, fifteen minute infusion, for osteoporosis, is now under review by the FDA for use in the United States. I don't remember the name, it may be called ''Reclaste'' (not sure). Now I don't know if this is a bisphosphonate (hope not) - but according to the news reports, the people who underwent the clinical trials, reported few, to no, side effects. Has anyone else on these boards heard about this treatment, and whether or not it's a bisphosphonate?

    TIA to all responders

     
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    Old 05-03-2007, 09:05 PM   #2
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    Re: New Osteo Drug Under Review

    Reclast = zolendronic acid
    It is indeed another bisphosphonate.

     
    Old 05-04-2007, 05:58 AM   #3
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    Re: New Osteo Drug Under Review

    Another serious problem that one medical expert said will probably delay FDA approval is that it can cause irregular heartbeat (afib). I would expect that prospect to make people, especially older women, to think twice about using it. My hope is they will find it possible to use Forteo beyong the two years. I don't mind the daily injections as long as I don't get side effects (I'll never forget how miserable Actonel made me feel). But at least they're working on more and better bone meds.

     
    Old 05-04-2007, 11:05 AM   #4
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    Re: New Osteo Drug Under Review

    If as Pika B says it is a bisphosphonate -that's not new. And if it is an iv delivered bisphosphonate -I don't think that is new either. Is it somehow an advance on the earlier bisphosphonates?

    Last edited by osteoblast; 05-04-2007 at 11:06 AM.

     
    Old 05-04-2007, 11:42 AM   #5
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    Re: New Osteo Drug Under Review

    Just a follow up. In researching Reclast, I found that it has now been approved in the US for treatement of people with Paget's. Novartis states it is being studied for treatement of osteoporosis.

    For those interested, you may want to look at a Medical News Today article dated 4/23/07. There is information in the article comparing reclast with actonel. I know there are a number of people on this board thinking of following forteo with actonel. One point of interest was that they found treatment with actonel to start working 89 days after start of treatment. Reclast started working within 64 days. I wonder would this be the same for people with osteoporosis?

    What does this mean for those of us on forteo---does it mean that our follow up drug does not take effect for approx. 3 months? If that is so , when is the best time to commence taking the follow up med-would it be before you complete forteo or would this diminish the effect of the forteo?

    I am going to save the Medical News Today article and take it to my dr as I get closer to finishing forteo.

    What do you others think about the implications of a lag period before actonel starts working and our desire to preserve forteo gains?

     
    Old 05-04-2007, 12:37 PM   #6
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    Re: New Osteo Drug Under Review

    Hi Osteo: You're right about Reclast, it has been used for Pagets disease and also for hypercalcemia and cancer related fractures.

    I don't know what the optimum timing would be to start your follow up with forteo, but I know that bisphosphonates (antiresorptives) blunt the effect of forteo, so they are not recommended while you're taking forteo. You could use the bisphos's after forteo, if you want, but I always thought it should start immediately after finishing forteo.

    I hope we have more options in a year or so, it will make my decision a lot easier. Has anyone called Lily and asked about the continuation on forteo??? I haven't; my insurance is still telling me they won't pay for it beyond the 24 months.

     
    Old 05-04-2007, 12:46 PM   #7
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    Re: New Osteo Drug Under Review

    Hi DesertBloom-if as the article stated actonel doesn't start working for 89 days ,then perhaps it would not diminish the last 60 days on forteo since the actonel is not starting to work yet. What do you think? I'll bet your Univ. dr. would be willing to think this through and have an answer. Would you let us know if you ever do present this question to her?

    Did you recently ask your med. insurer about extension on the forteo coverage? Maybe the insurer's coverage period is something that will, in time ,change if in fact the drug has now been cleared for longer use. It would be great to get a definitive answer on whether forteo has been cleared for treatment beyond 24 months.

    Last edited by osteoblast; 05-04-2007 at 12:58 PM.

     
    Old 05-04-2007, 02:18 PM   #8
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    Re: New Osteo Drug Under Review

    Hi Osteo:

    When I started taking forteo, my endo, incorrectly told me to continue on the actonel at the same time, and when my mineral metabolism Dr found out about this she was really dismayed, and wanted to know who in the world told me to do that!! Fortunately I didn't take both of them for more than a month or so, and when I told her that, she had this look like I took a hundred pound weight off of her. After seeing her reaction, I was really mad, at the endo, because it visibly shook her, and I didn't know any better. My mineral met Dr isn't the type to over react or get mad, she's really even keeled, great personality, so you can imagine how I felt, since I didn't want to take the actonel anymore anyway, it was making me sick, and the expense was too much added to the forteo. When this happened, I had been taking the actonel for over a year, so if this is correct about the actonel not working for 89 days, I was way past that time frame, and she knew it.

    This is the first I've heard of actonel taking that long to work, so I don't know what to think?? It seems strange, that so many people have side effects on the first pill. I didn't, it took a couple of weeks, but I remember it vividly, so I don't know how to explain that, if the med isn't suppose to be working yet. I suppose you could have side effects, before you get the actual bone benefits from actonel.

    Maybe this study you're talking about has changed the thinking, but I don't know since I've only had that one discussion with her about how bisphosphonates blunt forteo.

    I asked my insurance co about extending forteo, and they continue to claim that anything beyond 24 mos is considered experimental. This is ot, but don't forget to ask your Drs for a free pen occasionally, they need to rotate their stock on forteo and you don't want them to throw it out when they can give it to you.

    Last edited by DesertBloom; 05-04-2007 at 02:25 PM.

     
    Old 05-04-2007, 02:41 PM   #9
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    Re: New Osteo Drug Under Review

    I'd never heard of the 89 day period either, but could it be that it takes that long for it to build up in your system before it starts being effective in what its supposed to do? There are a number of drugs, like antidepressants, that take a while to get into the system and work. Just an idea...have a good weekend...phyllis

     
    Old 05-04-2007, 03:58 PM   #10
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    Re: New Osteo Drug Under Review

    The 89 day period for Actonel was in the Medical News Today article about reclast dated 4/23/07 . The beginning of the title is Reclast Receives U.S.
    Approval...

    What has me concerned is that Taape, a poster on this board, lost all forteo gains and then some within 6 months of ending forteo when she didn't follow with a bisphosphonate. If it takes approx 3 months for actonel to kick in what have you lost over those 3 months- maybe alot if you look at Taape's situation.

    Last edited by osteoblast; 05-04-2007 at 05:19 PM.

     
    Old 05-04-2007, 05:08 PM   #11
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    Re: New Osteo Drug Under Review

    Hi Osteo: I'm confused about something and thought maybe you could clear this up. I read the article you mentioned, and I thought they meant that people with Paget's disease responded to treatment after taking Actonel for 89 days as opposed to the Reclast group which responded in 64 days, making Reclast a better option.

    Now my problem is I don't know much about Paget's disease, so can we say that the study meant the same thing for osteoporosis, or that they just saw improvements faster in Reclast than Actonel for Pagets? I don't know, maybe you do. I also don't know what they meant by "responded to treatment," couldn't this mean a number of things and not necessarily anything related to osteoporosis or how long it takes the drug to work? If they saw improvements in those number of days, does that have to mean the drug isn't working until then? My guess would be that it's working but measurable benefits weren't seen until 64 to 89 days for that disease. Maybe you can help me out here because I'm not getting it

    If you look up Actonel from Proctor and Gambles pdf link, it states that bone marker increases were seen at 14 days after starting the drug for osteoporosis, so that would imply the drug is working in that time frame.

    Thanks for any help!!!

    Last edited by DesertBloom; 05-04-2007 at 05:21 PM.

     
    Old 05-04-2007, 05:52 PM   #12
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    Re: New Osteo Drug Under Review

    DesertBloom-Yes, there is the Paget's /osteoporosis difference to contend with and what that could mean I don't know.

    I like the questions you raised . Somehow the questions make me feel better about the possibility of something happening earlier than 89 days.

    In going back to the article they made the point that Reclast "starts working "faster than Actonel for people with Paget's. Then they compare # of days before "response to treatment" and use the 89 days for Actonel v. 64 days Reclast . I guess that maybe it could be as you speculate that it would be measurable response to treatment. And, I do like the info that you found at the Procter and Gamble site regarding bone marker difference in 14 days on Actonel. Good research!

    I would just like to know somehow that after forteo, we won't have the gains run out of us while waiting for the follow up treatment to start working. It does seem like the researchers are always busy in this field doesn't it? The results of these studies have already helped us.

    I just took a look at studies being done with denosumab by Dr. Michael McClung. I got there by just putting in the dr's name and denosumab and doing a search. Well, in journal published studies he states that osteoclasts were inhibited within 72 hours of commencing treatment. He goes on at some length regarding the fast acting nature of denosumab. While this hasn't been approved yet, maybe it will turn out to be a good follow-up option.

    With all the great people on this board , I have confidence that we will at least find some information to help us communicate with our drs. about the best approach after forteo.

    Last edited by osteoblast; 05-04-2007 at 06:10 PM.

     
    Old 05-04-2007, 07:04 PM   #13
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    Re: New Osteo Drug Under Review

    Hi Osteo and everyone else: I think we are doing pretty good weeding through all the info and studies, and that can only be a tremendous plus for all of us. I also love to *brainstorm* buy it takes a group of people with a lot of passion and curiosity, to do it successfully. I can't tell you how many times I've shocked my Drs by showing in depth knowledge on this stuff, as I'm sure you've all experienced as well. Several times I've corrected what my endo told me and was able to back up the statement with extremely reliable study sources. I know that Drs have to do a lot of reading, but they don't have the amount of time on their hands that I do, and probably some of you. I think that most of you work, but I don't, so that gives me the time to spend reading, which I love.

    I hope you all feel the way I do, because I sure know I get great info from you all

    My Dr @ LLU likes what she's read so far on denosumab, which I know I told you before, so you might be sick of hearing it, but I hope it gets approved sooner than the estimates.

    I don't want to loose any gains from forteo, I would be nuts if I said I did, but I don't think that Actonel would present a problem, as far as when it starts working, because from my own experience and what I've read about it's speed in reducing fractures over the other bisphos's I don't think that time frame (89) would be an issue, because I don't believe IMO, that's what they meant. Glad my questions helped in some small way, but that's how we're going to figure all this stuff out.

     
    Old 05-04-2007, 08:49 PM   #14
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    Re: New Osteo Drug Under Review

    DesertBloom- did your dr. give you any idea when denosumab may be approved?

    If anyone else has any information on possibly when denosumab may be approved please let us know.

     
    Old 05-04-2007, 10:35 PM   #15
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    Re: New Osteo Drug Under Review

    I called Eli Lilly on the doctor's line (purposely) and asked whether there were any studies or guidelines indicating the prescribing of Forteo past 2 years. The person said that it was not recommended, period. As you can imagine I"m not happy to hear this. I wish I could find a doctor that would prescribe it anyways at least until a patch or nasal spray is approved. I guess I need to check the FDA website or medical journals for more information.

    I'm also not happy that my doctor said that 6 months off of medication would be fine and then I find out that I'm worse than when I started the Forteo. Obviously, my system responded well to it. So I still worry about what to do and not wanting IV infusions and can't take oral medication. There are patients who took bisphosphonates which didn't work at all but most posters here plus some friends of mine report that the Forteo did help.

     
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