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Does anyone know how this works? Is it a bisphosphonate? Does it work the same as one?
Thanks
Does anyone know how this works? Is it a bisphosphonate? Does it work the same as one?
Thanks
Has Denosaumb been approved? No it is not a biophosphonate . If it works, IMHO Amgen's stock will go up even in this market. Google the name and you'll get some more info. Gloucester
No Denosumab hasn't been approved yet but no doubt it will be. I am concerned about this drug because I have read that it increases the risk of infections. zeta
Thanks for posting this..I will be watching to see what develps with this.
I found in in Google..also nearly fainted to see that AMGEN is selling 56.00 a share...I sold my Amgen stock about 10 years ago [or around that time I think] when it was hot at about 6 or 8 $ a share!!!
I have been advised to use Reclast but I am holding off as I have had problems with my immune system and am not anxious to take something that has a rare chance of causing problems..the last 2 immune problems I had have a 1 in 100,000 to 1 in 200,000 posibility of hitting someone..Since I have been the lucky jackpot winner in both of those [Guillain Barre' and Polymyalgia Rheumatica] I think I might sit Reclast out while hoping for something else to show up!
Raindancer - Is Forteo an option for you? Do you know, have read anything about it? My endo doc recommends for me and I'd like to have other input before I step into another treatment.
Here's a link on Denosumab that explains how it works versus Fosamax...
http://content.nejm.org/cgi/content/full/354/8/821
Hi raindancer and others,
Here is a link to an article that discusses a class of drugs called biologicals. Denosumab belongs to this class of drugs. Infection is a potential problem with biologicals, and someone else suggested to me that it might be risky for folks with autoimmune diseases, so this may be worth a look in terms of evaluating its potential safety.
http://jama.ama-assn.org/cgi/content/full/300/16/1887
zeta
windblown, thanks for posting the link re Denosumab versus Fosamax. There is a commentary on that article by Yazici MD. (a link to it appears at the end of the article you reference, but unfortunately only an excerpt is available to those who don't have a paid subscription to NEJM) which is highly critical of this article. The criticism involves a number of things, but I will note here that he takes issue with the failure of the authors, McClung and others, to adequately report adverse effects of Denosumab.
Even though it is just an excerpt, I encourage all interested in the safety issues surrounding this drug to click on that link at the end of the article windblown cites. zeta
Hi Zeta: I agree with you, that the incidence of neoplasms and infections are buried in table 2. I would hope, though, anyone reading this or any other study would always include the tables within the study, as part of their reading.
I read another article on this issue a while back where they take issue with the infections/neoplasms, but I can't find it now, but I believe it said that these infections were community based (study group) but I'm not absolutely sure on that. It may be on one of the other Denosumab threads-on this board-but I haven't looked there yet.
When considering any drug, make sure you don't have a potential additional risk to the form of treatment/drug, like the kind you mentioned for yourself (autoimmune disorders) before you ever consider taking it. I don't know if Denosumab will be approved, but it does seem to be looking like it will. What do you think?
I'm curious though, do you think that 6 patients (1.9%) with a neoplasm and 3 (1.0%) with infection-listed on table 2-is considered a large number of patients out of a total of 369? Just wondered, since the percentage seems low to me, but then I could be entirely wrong.
Thanks for the info on biologics... ;-)
Zeta:
Thanks so much for the information on the risk of Denosumab. It looks like it could be riskier than Forteo. I have seen on TV risks discussed with other monoclonal antibody drugs mainly I think for MS. Gloucester
Thanks for the reply windblown and Gloucester.
windblown, you raise a couple of points worth a mention, I think.
Just a first note on where adverse effects should be mentioned. Almost always, the body of the article contains the salient information and refers to a graph or table, but only to confirm, often by comparison with another tested item, the article's claim. For non-experts, it is notoriously tricky reading tables and graphs, so burying a result in a table or graph in effect hides it. It's just not enough.
The finding of neoplasm and infection, 6 and 3 cases respectively, is noteworthy. Especially in light of the fact that no cases of either were reported in the Placebo and Alendronate goups. It points to a problem, and must be investigated further, in my opinion. The withdrawals are also in the noteworth category because they're virtually all from the Denosumab group.
I also note that the lead author of this article, McClung MD., receives grant money from Amgen (the manufacturer of Denosumab), as do many of the co-authors, which sets me wondering about their objectivity, or possible conflict of interest.
Just a side note, I do not have an autoimmune disease; sorry if I was unclear on that.
I have no way of knowing of course if Denosumab will get FDA approval, but my hope is that it will not until it is investigated more forcefully regarding its potential for adverse effects. zeta
More information on Denosumab for those interested:
http://highwire.stanford.edu/cgi/medline/pmid;18981994
twice-yearly denosumab beneficial in postmenopausal women with osteopenia but no history of fracture?
Sherri-Ann M Burnett-Bowie
Nat Clin Pract Endocrinol Metab, November 4, 2008;
SM Burnett-Bowie is an Instructor in Medicine at Harvard Medical School and a Physician-Scientist in the Endocrine Unit at Massachusetts General Hospital, Boston, MA, USA.
This Practice Point commentary discusses the findings and limitations of the first randomized, placebo-controlled trial of twice-yearly denosumab to be performed in postmenopausal women with low BMD but no previous fracture. Bone et al. found that treatment with denosumab significantly increased BMD at all sites measured and reduced the levels of bone turnover markers when compared with placebo. Despite these beneficial effects, denosumab was associated with increased rates of sore throat, rash and infections requiring hospitalization. Furthermore, the study was limited by lack of information on antifracture efficacy, although such information will presumably be forthcoming in the near future. Here, I highlight how denosumab therapy differs from other antiresorptive agents with respect to mechanism of action and effects on BMD. The findings of Bone et al. suggest that denosumab might represent a novel anti-osteoporosis agent. Nonetheless, further investigations of efficacy and long-term safety are needed before denosumab can be adopted into routine clinical practice
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