New Drug therapies for Osteoporosis-DENOSUMAB

windblown
4 Recommendations

Hi All:



Raven and I have been discussing the possible approval of a new osteo med, and I thought I would start a new thread on it so everyone can find it. Keep in mind that this drug is in Phase III clinical trials, and just recently outperformed Fosomax in a head to head study, so we don't know yet if it will make it through the requirements of the FDA, but a proposed new drug application is scheduled for sometime in 2009 barring any set backs. The new drug is Denosumab or Dmab for you acronym lovers; it's made by Amgen in Thousand Oaks CA, and is a fully human monoclonal antibody, and NOT a bisphosphonate. Since Fosomax is going off patent, and if Dmab is approved, there may be a price concern, but this is completely speculative since we have no idea what the price would be "if" it is approved.



I've posted a link below, but unfortunately it wasn't the one I was actually looking for that had a greater explanation of the trials and how the drug works. If you want to know more you can query Amgen + Denosumab or Densomab v Fosamax (alendronate)" leaving out the words in parens. As of Jan 08, it's slated for a twice yearly subq injection, but I would imagine that could change if final approval is received. You can find quite a bit on this drug at various places, if you are interested. If interested, I would suggest seeking the newest articles you can find, since the info on this drug has changed over the years of it's clinical trials process. Medscape has a good article on it, but it's from 2005, so if you are registered there you can easily find it, or maybe a newer one. If you aren't registered, I would recommend it since they have great articles-plus it's free.



I will be finishing Forteo at the end of June and as yet have not decided what to take, but I'm leaning towards Evista because I had trouble with BP's (Bisphosphonates). If Denosumab gets approval I would consider switching to that since Evista works pretty slowly, and I have made great gains on Forteo that I don't want to loose.



Good luck to all...



http://www.mskreport.com/articles.cfm?articleID=2772

48 replies

Raven1

Hi Windblown,
I just read and printed out the article on DEMAB. Since it's dated Jan 08, it seems like it may get some approval relatively soon?? I hope! I know that time goes by so quickly.
I got some of my labs back and I again have to take a huge dose of Vit D. I can't wait until it warms up enough here to take some clothing off and get some D in through my skin. I walk on the beach every day, but I'm in a hooded parka. Spring in coming soon and I can't wait. I took the n-telepeptide 2nd urine test, but I'm not sure there was enough and if I did it right. I'm so unmedical.
I hope DEMAB is approved because I don't want to take more bisphosphonates and EVISTA is a hormonal based drug which can cause blood clots and I'm at high risk for a blood clot because I had one in my shoulder when I was 36. It's a great idea to keep tabs on these new drugs. We all benefit from our collective scrtutiny.

windblown

Hi Raven

Did the dr give you any specific instructions on the NTx test? I "don't" think there is a specific amount of urine that you have to give, so hopefully you'll get a great result. Since we are on Forteo we want the numbers to go up, so I would ask for a copy of the lab results and hang on to them for your next test and comparison. I realize I'm repeating myself ;) but this test is good for those of us who need some additional info in between dxa's.

My first test result came back at 78 which is an increase from baseline and also for my age and meno status. Normal for my age/meno status is 30, so I guess 78 is good, but then it dropped down to 60 on my last test, and the dr said she felt it was a result of the low dose estrogen I was taking. Since that last NTx I stopped the estrogen, so I hope my score goes back up on the next try. Antiresorptives (bisphos's, hrt, calcitonin etc) will lower your bone marker scores and supposedly hinders the positive effects of Forteo, so I won't be going back on hrt "again." I was only taking it because I have horrible night sweats, and haven't been able to sleep very well, but I'll just have to put up with that now that I'm off hrt, because I don't want anything messing up the good effects of the Forteo, especially since I'm almost done with it. Luckily I only took estrogen for 7 mos, so I hope it didn't do any real damage to the Forteo. It's funny that estrogen-by itself-is good for your bones, but not when your taking Forteo, or at least that's what my dr feels. If you want to read any articles on NTx and the other bonemarker tests, just let me know, and I'll post it.

My dr says that "any" increase is considered good because it means you are making new bone, you just don't want it to go down from the normal reference range. Since we are in different locales your lab may have a different normal range so don't be surprised. My dr has patients that had scores in the 300 range, and I asked if that is good, and again she said any increase is great. I think I might be concerned if my score came back that high, but according to her the higher the score the better (she's an osteo research dr at a local Univ Med Center).

Boy I envy you walking on the beach, I haven't done that in years. I used to live near the coast in college, and loved the walking. I hope it warms up there soon.

Is your vit D really low? Mine is low too, but I have high cal (hypercalcemia) so they won't put me on rx dose D, so I'm taking 2,000 IU's a day and hope that doesn't raise my cal levels. When you are on Forteo (might have mentioned this already) your calcium and D125 can go up by 19%, and your D25 can drop by 19% so keep that in mind when they check your levels--this info is listed in the Forteo literature under the calcium and mineral metabolism paragraphs, which they discovered during the clinical trials. My D25 and calcium were low and elevated before I started Forteo so no one can figure out what's going on. They've tested me for all the typical cancers :( and all the tests have been okay, so I don't know if I'll ever find out why my cal and D is messed up.

I hope your score is real good, and that you don't have any more scares on ice again...

Let me know what you find out if you feel comfortable posting that info.

Pam

windblown

Hi Raven and All: I forgot to mention that I agree with Raven, we need to stay on top of the new research that comes out on osteo meds, since a lot of the drs don't follow these things real closely until a drug reaches the market.

My dr knew about denosumab, when I asked her a year and a half ago, but she didn't have an opinion on it, even though she's in the research end of this medical disorder. I found out about it just by staying abreast of the new trials that come out, and that's pretty easy to do.

Hopefully we'll all have other choices, for drugs, when it comes to treating osteo than what is available now. There is also a company that is studying an oral form of Forteo, in Australia, so that may be of interest to some who have trouble with the price of Forteo or the injection process. The oral form is being presented in a tablet form that doesn't break down in the stomach, so it will be different from the way the injectable works since that form can't survive going through the stomach-hench the injection delivery.

Raven1

Hi Windblown,
I had very low Vit D before I began to take Forteo. I also had low levels of calcium ( 24 hour urine test) and I was tested for multiple myeloma by a hemotologist oncologist. Something that can account for low D is my suiting & hatting up in summer to protect myself from theravages of the sun due to basel cell carcinomas of my past. I have done such a good job that I'm not getting enough D in through my skin. I'm determined to "sun myself " this summer. I live on the eastern tip of the North fork of Long Island, surrounded by water. I swim and kayak all summer long but I haven't had a tan in years. I have to let the sun in without burning myself. I hope I can do it. Walking on the beach is a my great weight bearing exercise. What a pleasure!

I would very much like to read the article you mention about the 2nd urine of the day test (NTX) ? My instructions were very specifically my 2nd void of the day. I woke up at 5:15 am and immediately voided, then about 15 minutes later I did my 2nd void and that's what I gave them. It wasn't much and it was so soon after the first that perhaps it was to be considered only 1 1/2 voids???. I hope you are right and I don't need any more urine than I gave them, and it was truly the 2nd void of the day.

It's times like this that I feel very ignorant about medical procedures. I still can't believe that I inject myself with Forteo so easily every day. I don't think twice about it. I can think about preparing myself for the future and spend time looking into new drugs.

I feel entirely comfortable posting the information about my bone marker tests. It's really good for me try to understand the numbers and ask my dr for specific numbers to give me and explanations for them. I also didn't know that hormones caused forteo not to work. I think the same may be true for bisphosphonates. When I read about forteo I remember being concerned about Fosamax canceling out some bone growing. What's done is done. Whatever I get will be better than what I have.

I'll also start talking to my Dr about DMAB.

Best to evryone reading this,
Raven

Blues

Windblown & Raven, thanks so much for sharing your experiences with me and the rest of this group. I didn't know about the NTx test until I read about it in an earlier post (I believe by you Windblown). I asked my GP about having this test done (next month I'm due for other lab work); she's checking to see if Medicare will pay. I'll remind her when I go back in April. I'm hoping to have a new Dexa scan although Medicare says every 2 years but I think they will pay if you are being treated. I would like also like to read the article on the NTx.

I try to read as much as I can about meds. and test dealing with Osteoporosis because I know my dr. is very busy and doesn't always think of all the tools available.

I've got to get used to the new site; I've had problems finding past communications. Change is good.....?

Thanks, again.

Raven1

Hi Blue, Windblown and you all,
I'm trying to get used to the new face of the site. It's getting easier???!? I would also like to read the article about NTx. I typed the name of the test in and got test sires that were seemed to be labs and descriptions were too scientific for me to really wrap my brain around. I would love to find an easy to understand version of exactly what it does. I agree with you, Blue, we have to be proactive about our medical treatment.
Stay in touch,
Raven

windblown

Hi Blue and Raven,

Blue it's nice to meet you!! Medicare does pay for the NTx test. I have Medicare and this is how they pay. If you start a new drug, they pay for 1 baseline and 2 follow up urine NTx within the first year. The second year they pay for it 1 time, unless your dr states that it is medically necessary. You can look this up in the Medicare NCD manual which is available online. If you look it up in that manual, check for the section on "collagen crosslink" tests. If you aren't on a new drug, they pay for the test as follows: 1 baseline and 1 follow up within 12 mos. and 1 more the following year. In regards to dxa's you can have one every 24 mos or if you are on a "new" drug it can be done every 12 mos. If you are on a new treatment, make sure the dr writes the code for that. I had 3 dxa's in 3 years because of the new drug exception. When I had the first one I just started on Actonel, and then with the second and third, I was just started on Forteo, so I was able to have it done once every 12 mos.

Here's an article on bonemarker tests that is pretty easy to understand, and how and why they use this test. It's at Medscape, so you have to register first to read it, but from that point on you can access the site free of charge. I don't think it took very long to get the registration back (maybe a couple of hours) before I was able to access the site completely. You may want to have the site remember your username and password for convenience, but that's up to you.

Bonemarker tests can be done as a blood or urine test, but I've only had the 2 hour and 24 hour urine NTx (n-telopeptide). This test has been around for about 12 years, but some drs aren't real familiar with them unless they are an oncologist, or osteo specialist. My primary care dr wasn't aware of NTx, but my Mineral Metabolism dr was. It can also be used to check on the progress of other treatments besides Forteo, like the antiresorptives (fosomax, boniva, reclast, actenol, hrt, etc).

If you have any other questions don't hesitate to ask. Maybe we should start a new thread on this since it isn't really about dmab-so to speak ;)

Have fun reading the links,

Pam

http://doctor.medscape.com/viewarticle/463099

New Therapies and Bonemarker Tests- Includes info on Strontium Ranelate and Dmab (monoclonal antibodies of RankL).

http://www.medscape.com/viewarticle/549140_9

This following article is really long, and is a bit harder to understand, but it covers every aspect of the bonemarker test and then some... It also has graphs/pictures to help with the detail.

http://www.medscape.com/viewarticle/508542_print

windblown

Hi Raven, Blue and All: This is a note about the above post on NTx. The first link is the easiest one to understand, so start with that one at Medscape.

Nancy3

windblown,

Thanks for agreeing to be my friend, otherwise I would have dropped off this site.

No; I did not receive anything advising me of the changes. I just began to get emails from this new site and when I would open them my computer started doing strange things. I thought maybe it was a virus or spam.

When I went to the NOF site, nothing looked familiar and I was totally confused. From the FAQ's it was obvious I was not the only one who didn't know what was going on. One of the comments stated "I don't remember joining this site and how do I get off the list."

Just wanted to let you know the bed worked out fine and we are in love with it.

My husband and I went back to the doctor for more test about 10 days ago and we got the results today. He is being referred to an endocrinologist, who happens to be the same doctor I use for treating my diabetes. We had quite a discussion with the doc concerning my dh's decision not to take Boniva and said if it was him he would take it.

Today he asked him to begin Actonel weekly. We still haven't decided which med is the lesser of the evils. You mentioned that you are finished with Forteo and I can't keep these drugs straight in my mind. I'll have to look it up, along with the side effects. I know he would rather take something that receives positive reviews.

If you wouldn't mind; please give me a rundown on your experience with Forteo.

Glad I found you.

Nancy3

windblown

Hi Nancy,

Sorry your having trouble with the site, are you still getting the daily emails that tell you about new, and active threads? What I do is click the link to the replies to my posts and then check all the new and active discussion by using the link in the email.

I'm really glad the bed worked out, I was wondering what happened, and was hoping you didn't have bad news about it.

I answered you question about Actonel on your other thread, so I won't go into it here.

I haven't finished Forteo yet, the end of the 24 mos will be the end of June. I went on Forteo because my t-score didn't get any better on Actonel. I started out at -3.6 and stayed there until 12 mos after taking Forteo and at that point my score increased a whole point -2.6. I haven't had any side effects from the Forteo, and I wish I could take it longer than the 24 mos. Forteo is a daily injection, but I haven't had any trouble with it. I have to switch to a new drug at the end of the Forteo treatment, and at the moment it's looking like I'll take Evista, since I don't want to take any of the bisphosphonates. Hopefully Denosumab will be approved soon and I can switch to that instead of the Evista.

Good luck to you and your dh...

ShellyB

Hi I am new here and at first did not see too many discussions on Osteo. i would like to learn as much as I can. I was tested this past fall and am high risk..will get out my info tomorrow as I must get copies.
Dr let me know on phone message to pickup fosomax butafter I read info as her office gave me none..I returned the pills.My GI said not having very good luck with and I have 2 years off Interferon Treatment, they were not recommending me to get on it. I go back to Docttor and her NP said well youmade your decision and refused to talk about Reclast and other options. As soon as I get mytruckout of shop I amgoing to find a specialist because although I am an organic person I do need some help. I didnotsee a lot of discussion here but today..
I was with support on Interferon(still help new ones) and we kept more up with new meds, and care giving than our docs could keep up with but My GI atleast got back to me.My Family doctor and office just does not want to discuss other options so I am looking on my own. Then I may get rid of her.
I would like to learn more anyway I can. I take 1200 Calcium, 800 D, Magnesium and too many more minerals and vitamins. but no one went over my Calcium or my D. I havebeen on chondroitinand Glucofor 18 years.ButInever had a likng for Milk.
Interferon robs lots of things from body but I was shocked to get report and then no support.soany help thanks.
I will get more info onto profile but I am in some pain right now as I pulled a muscle and this gets to me for too long. I amhaving surgery as I have a toe thathas disentegrated..Freiberg disease and it is from Osteo.
Rare and woman's disease. I have put off surgery but cannot run too much longer..
Support is a good thing. I never thought I could come online and chat but I have made friends all over the world and that was so good to have while battling I wish you a goodday...

Raven1

hi windblown, blue and everyone else on this line. I just found out that the n-telopeptide test that I just took after 4 months on Forteo is my base line. i'm really annoyed at my dr., but, it just goes to show how important it is that we be informed about our treatment and new drugs coming on to the market. I should have had that base line done before I started Forteo.

I don't like this new site. What is Inspire? I'm having trouble getting on to it. When I click onto anything in the daily newsletter I get a screen that says "Whoops!" It's a royal pain.
They also changed my name as you can see. I'll try to keep posting. Right now I'm off to read the articles on collagen cross link tests. Thanks very much windblown. I registered at MEDECO which was quite easy. I'll let you all know what I think.
Raven1

windblown

Hi Raven and All: The same thing happened to me on the NTx test, because I couldn't find a dr to order it until I was on Forteo for 4 mos. I would have really liked to have know what my score was before I started it, but oh well. I was told by my osteo dr that normal for my age and post meno status would be "around" 30 if I wasn't taking Forteo so when I got the first test back and it was at 68, I was happy about that since she was able to give me a ball park score for someone who hadn't started Forteo yet.

I'm not having any trouble getting onto the site, I still do it the way I always have, but I'm trying to get used to the changes. I got an email explaining the name change to Inspire, and from what I understood it would be a larger group with other medical disorder boards "including" the NOF. The name is suppose to represent inspiration through the members. That may not be a very good explanation of what I read, but that's what I remember.

I haven't gotten any "whoops" screens so I don't know what that could be. When I joined the NOF I added it to my favorites lists so I just click that link and it takes me to the Inspire/NOF site without any problems, the same way it always did. I'm trying to get used to the changes so we'll see what happens. If you haven't contacted anyone yet about your error screen (whoops) I would try to find out what that's all about and maybe it could be easily fixed. I still use the email/newsletter I get to get to others replies to my discussions, and any new threads, so that hasn't been a problem.

I hope the Medscape article helped, and let me know if you have any questions about it.

Talk to you all later...

idie

Hello,
I have never ever blogged, so I have no idea what I am doing. Read your blogs, windblown, and would like to thank you for the info you continue to post. I have struggled for 2 years with the bad dexa results I received, -3.4 in my spine and 2.6 in my hips. The doctors wanted to put me on Fosomax or Forteo immediately, and I was terrified. Terrified of the potential risks, the side effects of possible jaw necrosis, etc. I opted for HRT - a patch of the lowest strength. Haven't had a dexa in two years out of fear, but know that I must have another one soon. The reason I bring this up is that reading your and other's blogs encourages
me to finally go back to a doctor instead of sticking my head in the sand. These blogs really are supportive and
encouraging besides informative.There is nothing better
than a group of people who are talking about their own
experiences with medication and their knowledge that you
wouldn't necessarily get from doctors. I will continue
to read the blogs and take comfort in knowing that
I am not alone with this awful osteoporosis.
Edie

Blues

Windblown, finally got around to reading the link you posted for Denosumab and then searched Amgen+Denosumab and found a press release dated 2/22/08; I hope they continue to have success and get this on the market soon. I am especially happy to read about the effect on hips since my left hip (last dexa) was -3.2 (spine -2.8). That's after 6-7 years on Fosamax. To others who are taking Fosamax don't be discouraged by my results I've read on this site about others who have had excellent results with Fosamax. I'm hoping for better results on Forteo.

windblown

Hi Edie Welcome... I'm glad we all could help you out some how. Are you considering taking Forteo? I took Actonel for over a year and it didn't help my t-score any, but lots of people get good results from it, I guess it just depends on how your body reacts to it.

Unfortunately all drugs, foods etc cause side effects, you just have to find something you can tolerate and that helps to build new bones. Like I mentioned I haven't had any trouble with Forteo so I recommend it, but the decision has to be yours.

If you want to read new or active posts just click on the tab at the top of the screen that will take you to those. There are plenty of other threads on the antiresorptives like iv reclast or boniva, actonel and fosomax. When you've read the thread you're interested in just go to the next page to continue reading that topic.

If you have any questions on Forteo don't hesitate to ask, if you are considering it. Have you read the Cleveland Clinic PDF on it? That will give you a lot of info on it, both the positive and negative.

Good luck with whatever you decide to take, and you can always start your own thread and the others will jump in with their experiences.

idie

Hi windblown, thanks for responding to my blog or whatever
you call it. Don't think I can take Fosamax, Actonel or Boniva,
I had very bad reactions to them. So I only have Forteo
left as a choice. I have not read the Cleveland Clinic PDF,
but will do so in the next few days. All of these drugs are
scary to me and I wish there would be more natural and
effective medications for us to take. When you do research,
you realize that we don't have all that much to choose from.

How do you do your own thread? Thank you so much.
Edie

windblown

Hi Shelly, Welcome to the group...

I don't know anything about Interferon, does it have a negative effect on your bones? I wish you luck with your surgery and hope you can get more answers from your dr on osteoporosis.

Do you know what your t-score is? It sounds like you are only taking the vitamins, are you thinking about adding one of the bone meds, and exercise?

I hope your surgery goes well, and you can get more info or a new dr for your osteoporosis.

windblown

Hi Edie: Have you done any reading on Strontium Citrate? That's the only other med that most consider natural. It's the OTC version of Strontium Ranelate which they use in the UK and other countries for osteo but isn't approved for use in the US. I don't know if it works and if you ask a dr about it they will probably tell you they either know nothing about it, or it doesn't work, but you certainly could look into that. There are some here taking that as well.

For "me" Forteo has been great, but like all meds it could have side effects that I haven't experienced. There's also miacalcin nasal spray (salmon calcitonin hormone), but they say it works really slow and isn't recommended for anyone with really low t-scores, but then again a lot of people have success with it, but usually if in the osteopenia range.

Hopefully there will be more options in meds soon... Since you can't take bisphosphonates, that leaves out most of the meds unless you consider Reclast. As you know, Reclast is an iv bisphosphonate, so they say it doesn't cause the gi and esophagus problems, but I've never used it; however there are quite a few here that are taking it. The gi problems are avoided because it bypasses your stomach by going through an iv. You could do a Search on the name if you're interested in it, or reading the others opinions on it. The Search box is at the top right of this page.

To start a new thread/discussion, scroll up to the top of this page and click on "Start a Discussion" it's on the right hand side of the screen, and just write about whatever topic you'd like.

Also, if you want to read the Cleveland Clinic PDF on Forteo, just click on my name (above next to picture) and scroll to the bottom of 'following' page, which is my personal page, then scroll down to "My Favorite Links" and it's the first one listed along with some others you might be interested in, on the right side.

Glad you could join us, and hope you find a treatment that is right for you.

MotherGoose

I would not plan on exposing my skin to the sun, if I were you, with your basal cell carcinoma history. That " history" is still there.
You are getting good resistance exercise for your shoulders when kayaking, but be carefukl getting in and out of the kayak and keep your back all in a line, bending at the knees and hips. Be sure your back is not rotating just at the waist, but involving the pelvis as well.
Walking on the beach is also strengthening for your legs -- that sand makes it more work than simply weightbearing on the pavement, doesn't it!
Lucy Buckley PT

Add to the discussion

New user? Join here.
Forgot password?
Keep me signed in on this computer until I sign out

Search

Find information and discussion about health topics in 350,482 posts by members like yourself. Learn more...

Join

Join safe, secure groups sponsored by trusted organizations that care about your health. Learn more...

Connect

Connect with 88,079 members and make friends who share your interests, learn about conditions and treatments, find support and more. Learn more...

You