Discussions that mention reclast

Osteoporosis board


I just read in our local newspaper last night about the once a year infusion called Reclast by Novartis that is about to be approved. Does anyone have any information about this drug?:confused:
Quote from Sassiesmom:
I just read in our local newspaper last night about the once a year infusion called Reclast by Novartis that is about to be approved. Does anyone have any information about this drug?:confused:



Hi Sassiesmom: I just read about this drug, and Novartis has applied for an NDA (new drug application) with the FDA on 9-16-06. It's also known as zoledronic acid, which has been around for awhile. Unfortunately, I don't know how long it takes the FDA to approve these drugs, but from everything I read, Forbes, Novarits, other osteo web sites etc, they say it seems "promising". I'm not sure how they come to that conclusion, since the final stage is up to the FDA, but since it's a *once* a year *15 mins* infusion, they feel it will help a lot with patient compliance, and also for the patients that can't tolerate oral bisphosphonates, due to the intestinal, and esophageal probs. In the clinical trials, the most common side effect after 3 days was: headache, fatigue, and bone pain. After that amount of time the effects seem similar to oral bisphos... w/o the instestinal probs. I couldn't find anything on the half life of the drug, but am sure anyone interested could find that info out thru various sources.

The company claims that it decreases spinal fractures by 70% and 40% in hip fractures and helps fracture prevention in other areas of the body (paraphrased). Make sure you verify this, to make sure my figures are correct. One thing that wasn't mentioned was how long it takes to get these percentage increases, but these figures are quite high, so I hope it is accurate, over a period of time. I have found that when you read these precentage claims, they tend to leave out the amount of treatment that is necessary to reach such a high % rate success.

Good Luck, if you're considering this... And I hope it doesn't take long to get the FDA to put it on the market.:wave:

Pam
Below is a very good link to research on ONJ:

[url]http://www.rheumatology.org/publications/hotline/0606onj.asp[/url]

We all have to remember that "all" bisphosphonates have side effects, just like all medications, foods, vitamins etc.

Aredia and Reclast are made by the same co. (Novartis) but they are not the same drug. They are in the same 'class' of drug, iv infused bisphosphonates, but to say that these two meds are the "same stuff" that is causing ONJ is inaccurate. "All" bisphosphonates have the ability to cause this, and some more than others, but you also have to remember that the greatest risk factors are for cancer patients, patients on long term corticosteriod treatment, patients with dental trauma, etc. The number of non cancer post menopausal osteoporotic patients being treated with oral or iv infused bisphosphonates contracting ONJ is still very small. Of course that is not to say we shouldn't be very careful with these drugs and fully consider their impact before agreeing to take them.

In the end all you can do is weigh the risk vs benefit of these drugs, and decide for yourself what you will do.

I am personally more afraid of osteo, than ONJ, because I don't believe I fall into the high risk category for contracting Osteo Necrosis of the Jaw. Osteo... is a disease I already have at the severe stage, and I'm not going to worry about possibly contracting another disease many years down the road when I'm not considered to be at high risk for it anyway and where the instances of contracting it are very low. Should I deny myself it's benefits, if it could help me tremendously? I have enough problems without adding more unfounded ones to the list.

I have never had cancer, nor have I been treated with long term cortisones, and I haven't had any oral traumas, chemotherapy etc, so if I was told that this drug "could" improve my t-score over a relatively limited amount of time, I would consider it's use. On the other hand if I had all of the known risk factors that contribute to ONJ, then I certainly would think twice about using it.

The half life on this drug is probably something I wouldn't want to deal with, but before I would worry about that someone would have to prove to me that this is proven to be extremely detrimental, which so far I haven't heard, given my personal med history.

Good Luck to All...
It would be nice to only have to be treated once per year. I take weekly Fosamax now, but if Reclast is demonstrated to be just as effective I'd be glad to switch.
Quote from Kaitrin:
It would be nice to only have to be treated once per year. I take weekly Fosamax now, but if Reclast is demonstrated to be just as effective I'd be glad to switch.


Kaitrin I agree with you... If the FDA approves this, and it's as effective as claimed, I would switch to this when I'm done with my forteo. I like the idea of avoiding the stomach/bone pain probs that go with the oral bisphos... so I hoped it is approved. A once a year injection over 15 mins sounds great to me, and since it's a low dose, the onj worry is extremely unlikely for that reason and others.