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Osteoporosis Message Board


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Hi Aleta: I’ll try to answer your questions the best I can. In the Forteo v Fosamax Trial for Back Pain Study, they reported a significant reduction in back pain in the Forteo group and no reduction of pain in the Fosamax group. The researches further explain that the reason for pain reduction in the Forteo group is “unknown.” Even though these results were seen they could not explain the action that the drug might have to reduce back pain. So the answer is no one knows how that would happen. If you want to read more about this do a query on Forteo for back pain and see if you find anything interesting. But for me it hasn’t helped with the pain, so I can’t explain how it would anyway and it seems no one else can either.

I thought that Forteo makes your bone more dense not necessarily larger. When I went to the training class for the pen instructions they explained Forteo’s actions with the following analogy. I hope I can remember exactly how they explained this, so keep in mind that this is what I remember. They compared Forteo working on bone to a road crew that was fixing pot holes on a street and then laying down cement after the holes were filled. The crew fills the pot holes with cement (Forteo) and then a cement truck lays down a new top coat over that to reinforce the newly repaired holes. I’m sure someone else could explain this better, but that’s how I remembered it. So if Forteo fills the holes in your bone, that would make your bone stronger and more dense, then the additional layer of bone that is placed over that reinforces the repair. So I don’t think the bone actually gets bigger, but it does become more dense and of course stronger-but I'm not exactly sure.

The FDA, and an expert panel, approved Forteo with a black box warning saying that the rat study was unlikely to predict bone tumors in humans taking Forteo, and included this info in the package insert. The risk of osteosarcoma would be very small due to the following reasons.

1. In the rat studies the dose was 3-60 times the human dose given over 75% of their lifetime, so contracting cancer was dose and length dependant.

2. Fisher rats are more susceptible to osteosarcoma, and contract it at a 1-3 in 1,000 rates, where human’s incidences of osteosarcoma are 4.5 in 1 million.

3. Humans would only be able to take the drug for a period of 24 months unlike the rats who received it for most of their lives.

4. In the second study done on Fisher rats that were treated with the human dose of 20 mcgs for 6 to 20 months, none of the rats contracted cancer.

5. The rats in the first study were younger, than those used in the second, so their bones were still growing, which is a contraindication in the use of Forteo. Forteo can only be used in subjects where their bone is no longer maturing.

You can find this info in the CCJM pdf on Forteo. Pg 591

I don’t know exactly why they stopped the that trial, except that it’s not unusual to stop a clinical trial when an adverse event is found in animal trials of the drug. There were a number of other trials going on at the same time of this finding that weren’t stopped, but there was a time limit on each trial for drug administration.

HTH:)
Hi Aleta: Unfortunately, all rats are predisposed to "some" cancers, but not all of the types we humans see. When they started the study they couldn't have known that the rats would get osteosarcoma from Forteo. The purpose of the trial was to find out what negative/positive effects it had on the rats, however even though we know that rats are predisposed to most cancers, there's no way they could have known that Forteo would cause osteosarcoma, so stopping that particular human trial was the only prudent thing they could do. Could you imagine what people would have said if they didn't stop the trial, even though human osteosarcoma was rare. The rat studies were the first hint that osteosarcoma could occur at high doses, for long periods of admin, in animals of a young age with growing bones.

I've had a QCT scan twice, but each was before I started on the Forteo. I had the option of having another one instead of a DXA, but choose not to do that. From what I've been told, the QCT over estimates the bmd and DXA under estimates it. I don't know what having another QCT would do, other than confuse me more, so I think I'll just stick to the DXA. This is all so confusing anyway... I don't believe these tests are prefect anyway, so I don't put a huge amount of trust into either. If my score increases that's great but I have to remember the error rate, things that can change the score artificially, like arthritis, hardware, and scoliosis, and then try and figure what the numbers mean:confused::confused:

I was thinking about what your husband said about the bone getting larger, and wondered if it would negatively affect the discs, but I don't think it would. He has bone loss in the spine-right?? So if Forteo increases that by filling in the resporptive cavity, and then a protective layer, it may enlarge the bone but hopefully only back to it's original pre-loss state, like what it was at when he was young. If Forteo could actually return our bones back to perfect density, then Forteo would be some sort of miracle drug-right? I don't think it overly enlarges it to the extent that it would interfere with the discs. There is a disease that grows bones rapidly and makes them go way beyond their original state, which would be horrible, but I can't think of the name of it right now. When I look at my x-rays my discs are almost indistinguishable, but the fxing has stopped for now. It was the fxs that caused the most damage to my discs, so I hope he doesn't have that problem. I still don't understand how Forteo could cause pain relief...but apparently some say it does:confused: Did you read any of the studies on this??

Anyway let us know how his training goes, and hopefully it will work fantastically for him!!!!!





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