The news was out yesterday on 5 years of Protelos (strontium ranelate). Its not a hormone like Forteo and Preos. It doesn't just slow bone death like the bisphosphonates nor does it just increase bone formation like the parathryoid hormone drugs. Protelos both increases bone formation and decreases bone resorption. And it's the first and only anti-osteoporotic treatment to show five-year, evidence-based efficacy against both vertebral and non-vertebral fractures. It was approved in Europe in September 2004.
The Phase III clinical trials were called SOTI (Spinal Osteoporosis Therapeutic Intervention, involving 1649 women) and TROPOS (Treatment Of Peripheral Osteoporosis, involving 5091 women) just in case you want to search for the results yourself. All women received calcium and vitamin D supplements during the trials. Signifcant improvement was seen after only 1 year of treatment. Measurement of bone density was done every six months and vertebral xrays annually during the trials.
Some antibiotics are not compatible with Protelos, it shouldn't be used in those w/severe kidney disease and the drug was associated with blood clotting during the trials. Unfortunately, it is a powder mixed with water recommended to be drunk two hours after a mean. (I'd much prefer a pill!)
I did find one letter criticizing the trials for including little information on the adverse effects of strontium. Some points of criticism were:
1] Strontium caused a 50% increase in the risk of venous thromboembolism (including pulmonary embolism).
2] Strontium also increased serum creatine kinase activity in 30% of patients.
3] Neurological and muscular adverse effects were inadequately documented, although disorders of this type were observed in animals.
4] Data from experimental studies and dialysis patients with renal failure raise the possibility of these adverse effects.
5] There is not enough evidence of clinical advantages over diphosphonates.
The use of the term "disphosphonates" confused me. Did they mean "bisphosphonates"?
My question is: will Protelos be trialed in the US for possible approval AND will there be stringent oversight of the reporting of adverse events during those trials. Because, frankly, Protelos sounds interesting, exciting and promising. But keeping in mind Merck's current problems over under reporting adverse cardiac events w/Vioxx ....
"My question is: will Protelos be trialed in the US for possible approval AND will there be stringent oversight of the reporting of adverse events during those trials."
That's the million dollar question. Drug companies employ countless strategies to mislead the public and the FDA about the negatives of their drugs and it's all perfectly legal. Here's just one (I've talked about it before): They begin with a group of test subjects, give them the drug for a short period of time and up to 2/3 of the group, who have any number of adverse reactions, can be dropped from the study. They're called "losers" in the industry. Depending on the drug, number of problems, etc., they repeat this process any number of times until they're satisfied that those who remain, will, at least initially, have a positive experience on the drug. The premareting trials then begin. Does that sound to you, like the results of the study would reflect how the general population would react to a drug? Certainly not and that's just ONE of the underhanded, irresponsible things a drug company can do to get their drugs approved. Skilled writers and no back-up testing by the FDA, can also help tremendously in getting drugs approved, that possibly shouldn't be.
Thanks for more detailed info. about how drug companies operate! I knew they were lax to report side-effects but didn't know exactly how they went about choosing subjects and such for the trials. This is such a serious problem because so many people have bought into the medical model of treating with these toxic drugs.
I know there are many who post here who rely on these drugs. I don't fault them for their choice, because it IS their choice. I look to the drug companies for perpetuating deception in the name of greed.
A bit of an aside, but not really. I don't know if anyone saw the segment on 60 minutes last night. It was about global warming and how the scientists who are trying to warn us about this very real problem, and how it is already having effects on our planet, are being censored and silenced by our administration. It reminded me of the book/movie Farenheit 455 (I may have the number wrong.)
Thanks for the info on this, CrohnieToo. I looked at Servier's site. It does say the patients who dropped out of the study did so because of nausea. I'm trying to make sense of the numbers regarding the venous thromboembolism...It looks like 0.7% or 7 out of 1000 had it, which was about 42% greater than those on placebo, so I guess that the normal risk for VTE is about 4-5 people out of 1000, according to their study. Hence their recommendation that people at risk for VTE not take the drug. Of course, it may be years before we in the USA see it, so by then there should be a lot more post-marketing data available.
My rant on the FDA:
There was a time when the FDA was accused of being too slow to approve new drugs and was depriving patients of drugs that might be beneficial for them. Due to these complaints, Congress passed a new law in 1992 allowing the FDA to make its drug approval process much faster.
Having the drug companies conduct their own studies is indeed problematic, but I'm not sure that we should have the FDA conduct them either. Think of the HUGE bureaucracy it would require to test all the drugs in the pipeline. And considering their past performance, I'm not sure I'd be willing, as a taxpayer, to finance it. Perhaps an independent company should do all clinical trials? I wonder if that's at all feasible, because who would pay for it? That company could also be required to follow up on post-marketing adverse events and report them to the FDA which I agree is the most serious defect in the current scheme of things.
By the way, I looked it up and it seems that diphosphonate is just another way of saying biphosphonate, di- and bi- both being root words for "two".
Dx 5/04, age 49: Spine -3.0, Hip: -1.9
5/05: Spine -2.7, Hip -2.1
Current treatment: Evista