Is your company seeking approval of Protelos (strontium ranelate)for osteoporosis in the United States of America? If so, at what stage in the process is it?
BoneLady
Thank you for your interest for Protelos. Protelos is registered in 84 countries worldwide but has not yet been filed to the FDA and thus, for the time being, it is not possible to give you any indication on availability date in the USA.
Sincerely,
M. Rebuffé-Scrive
Scientific Director Servier International Canada, USA, Northern, Central & Eastern Europe
Skeleton Pirate
Artist: LindaB
WELCOME TO STRONTIUM FOR BONES BLOG
Have you experienced negative, and even dangerous, side effects from Fosamax (alendronate), Boniva (ibandronate), Actonel (risedronate), Reclast (zoledronic acid), Prolia (denosumab), Forteo (teriparatide), Tymlos (abaloparatide), or other drugs prescribed for osteoporosis? If you have, then rest assured there is a safe, effective treatment for this condition. Strontium, primarily in the form of strontium citrate, is taken orally once a day.
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Browse the posts and visit the link library of references.
Visitors to my blog can leave comments or ask questions and can remain anonymous, if they wish. Their comments are relayed to my g-mail inbox. Below each post, the number of comments for that post is cited and underlined because it is a link. By clicking on that link below any post, a window opens so that a visitor can leave a comment. Ideally, visitors leave comments on posts most relevant to their comments. All comments to my posts are moderated by me.
Browse the posts and visit the link library of references.
Wednesday, May 21, 2008
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Wandering Skeleton
Artist: Joel Hoekstra
Osteoporotic Bone
Source: www.mayoclinic.com
How Strontium Builds Bones
Strontium is a mineral that tends to accumulate in bone. Studies have shown that oral doses of strontium are a safe and effective way to prevent and reverse osteoporosis. Doses of 680 mg per day appear to be optimal. See my "For More Information About Strontium" links section.
Osteoporosis is caused by changes in bone production. In healthy young bones there is a constant cycle of new bone growth and bone removal. With age, more bone is removed and less new bone is produced. The bones become less dense and thus more fragile.
Scientists believe that strontium works in two ways. It may stimulate the replication of pre-osteoblasts, leading to an increase in osteoblasts (cells that build bone). Strontium also directly inhibits the activity of osteoclasts (cells that break down bone). The result is stronger bones.
When taking strontium, be sure to take 1200 mg calcium, 1000 IU vitamin D3, and 500 mg magnesium daily. It is best to take strontium late at night on an empty stomach. Calcium and strontium may compete with each other for absorption if taken together.
Osteoporosis is caused by changes in bone production. In healthy young bones there is a constant cycle of new bone growth and bone removal. With age, more bone is removed and less new bone is produced. The bones become less dense and thus more fragile.
Scientists believe that strontium works in two ways. It may stimulate the replication of pre-osteoblasts, leading to an increase in osteoblasts (cells that build bone). Strontium also directly inhibits the activity of osteoclasts (cells that break down bone). The result is stronger bones.
When taking strontium, be sure to take 1200 mg calcium, 1000 IU vitamin D3, and 500 mg magnesium daily. It is best to take strontium late at night on an empty stomach. Calcium and strontium may compete with each other for absorption if taken together.
For More Information about Strontium
- A Dose-response Study With Strontium Malonate
- A Review of the latest insights into the mechanism of action of strontium in bone
- Antifracture Efficacy Over 10 Years With Strontium Ranelate
- Combination of Micronutrients for Bone (COMB) Study: Bone Density after Micronutrient Intervention
- Echolight REMS Scan of Young, Normal Female
- Effect of bone strontium on BMD measurements
- Effect of Lumbar Scoliosis on DXA Results
- Effects of SrR on Calcium Metabolism
- Effects of strontium ions on growth and dissolution of hydroxyapatite and on bone mineral detection
- Influence of strontium on bone mineral density and bone mineral content measurements by dual X-ray absorptiometry
- Interpretation of BMD Scans in Patients Stopping Strontium
- Melatonin-micronutrients Osteopenia Treatment Study (MOTS)
- National Osteoporosis Foundation
- Osteoporosis And Bone Physiology
- Post-Marketing Assessment of the Safety of Strontium Ranelate
- PubMed Abstract On The SOTI Study
- PubMed Abstract On The TROPOS Study
- Strontium ranelate Aristo
- Strontium Ranelate For Spinal Osteoarthritis
- Strontium: Breakthrough Against Osteoporosis
- Summary Safety Review - Strontium
- The Influence of Strontium on Bone Tissue Metabolism and Its Application in Osteoporosis Treatment
- Thirteen Key Diagnostic Tests
19 comments:
can it (protelos) be used for treating fibrous dysplasia?
marielle.rebuffe-scrive@fr.netgrs.com to me
show details 11:34 AM (1 hour ago) Reply
Thank you for your interest for Protelos.
Protelos is registered in 92 countries worldwide but has not yet been filed to the FDA and thus, for the time being, Protelos is not available in the USA. Therefore, due to US customs and FDA regulations we cannot supply this prescription medicine to the USA and we are not selling Protelos online.
For your information, at least for the time being, the indication for Protelos is "for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures".
Sincerely,
M. Rebuffé-Scrive
Scientific Director
Servier International
Canada, USA, Northern, Central & Eastern Europe
Can Protelos be used to treat fibrous dysplasia? In the U.S.A., bisphosphonates are used to treat this condition when there are symptoms of the disease.
BoneLady
Have you told your endocrinologist you are taking Strontium? If so, what does he/she say? I started taking it in May 2008, but I am only taking 340mg daily instead of the suggested 680 mg. I worry a little because I have read it changes the internal structure of your bone (plates instead of rods or something like that). What is your thinking about that? And what if it is impure, lead etc?
My Endo wants me to take the yearly IV form of Fosomax, but I don't want to because I worry about the necrosis of the jawbone. And I think it is a horrible drug.
Response to 10/22/08 post:
I have never seen an endocrinologist. I have been to an orthopedic surgeon for spinal problems. I have a family physician who ordered a Dexa scan at my request because the orthopedic guy would not, although he thought it was likely I had osteoporosis. When the results came back, my family doctor prescribed Fosamax once weekly for me, and it made me very ill. I have not been back to see him since getting off Fosamax and going on strontium citrate.
Doses of 680 mg elemental strontium per day appear to be the optimum dose, although lower doses are clinically effective. Strontium tends to accumulate in bone,especially where active remodeling is taking place. This is a good thing, because it helps prevent and reverse osteoporosis. As for assurance on the purity of any product, deal only with companies that have a good reputation. I buy Doctor's Best Strontium Bone Maker.
If you take a once-yearly bisphosphonate by IV and have a bad reaction, it could take a year before the drug is out of your system. Jaw necrosis is more common with the IV form of bisphosphonates.
I wish you the best whatever you decide.
Bisphosponates are toxins. Some are
used to treat bone cancer. Their
method of action is that they are
more toxic to bone=breakdown cells
than bone building cells. The interval between doses is not how
long it takes to clear the drug from the body. Rather, it is the length of time it takes for the most affected cells to recover.
RE: Bisphosphonates are toxins. Strontium Chloride is radioactive and used to treat bone cancer. Does that make Strontium toxic too?
To: Anonymous, 01/11/2010,
Certain bisphosphonates (e.g., Zometa) are used to treat breast and other cancers that have metastazized to the bone.
Strontium chloride is not radioactive when the strontium is stable strontium. Strontium chloride was used in toothpastes for sensitive teeth (e.g., Sensodyne) before nitrates became more popular.
You are talking about strontium chloride Sr 89, which is radioactive. Strontium chloride Sr 89 is used to help relieve the bone pain that may occur with certain kinds of cancer. The radioactive strontium is taken up in the bone cancer area and gives off radiation that helps provide relief of pain.
Strontium citrate is not radioactive because it contains stable strontium. Strontium citrate is nontoxic and well tolerated by most people at the recommended dosage of 680 mg strontium daily.
can i use protelos and biphosphonate in the same time.......
taha,
To date, there have not been any published clinical trials to test the safety and efficacy of concurrent use of a bisphosphonate and strontium renalate or a bisphosphonate and another strontium salt. Now and then, you can check www.clinicaltrials.gov/ to see if anything new comes up.
I have read testimonials from a few people who said they are successfully taking a bisphosphonate and strontium citrate concurrently. These people posted at www.inspire.com, which is an osteoporosis discussion group of the National Osteoporosis Foundation (NOF).
I've had MRI's and been diagnosed with bone spurs. I have a lot of pain with this condition. Will the Strontium Citrate help with the pain issue, as well as rebuilding bone?
Constance,
The treatments for bone spurs that cause pain are pain medications such as NSAIDs and surgery. The Mayo Clinic has information on bone spurs at www.mayoclinic.com/health/bone-spurs/DS00627.
I have never seen a study on the use of any strontium salt for bone spurs. Bone spurs usually occur as a result of a disease condition--commonly with osteoarthritis (OA). There was a study on the "Effects of Strontium Ranelate on Spinal Osteoarthritis Progression." The results suggest that strontium ranelate could reduce the progression of the radiographic features of spinal OA and back pain in women with osteoporosis and prevalent spinal OA. I have a link to this abstract at the end of my blog. Under "For More Information About Strontium,"click on "Strontium Ranelate for Spinal Osteoarthritis."
I hope you find relief from your pain.
I am 51 years old male. Found out aboout Protelos from my doctor at Columbia University Hospital. Nothing worked well from fda approved drugs to treat my osteoporosis condition. I started using Protelos for 5 month now. I purchased it in Germany. Bone density test shown dramatic improvements in my spine (almost 11%) new bone mass. And 2.3% increase in hip as well as in my arms.If this is a treatment choice of 73 countries around the world than why is FDA so thick headed.
mikhail,
Thank you for your comments, and congratulations on your success with Protelos. However, we cannot blame the FDA for not having the drug approved in the U.S.A. Servier, the manufacturer, has not filed for FDA approval. The company must take that first step to begin the lengthy approval process.
got so sick after taking usa drugs after 2 pills. I was in France seeing family I asked what could I take for this bone problem I was told about Protelos I have now been on this for three years with outstanding results I had no idea that I could not bring this into the country. Well I will stay with what I know is best for my body and hope that it will be appoved some time soon
To Anonymous of 01/01/2011:
I am glad that you are doing well on Protelos (strontium ranelate). Based on what Servier's representative said, I do not expect Protelos to be approved for use in the U.S.A. anytime soon. The company has not even filed to begin the approval process--perhaps it never will-- and the entire process can take many years.
I am waiting for the results of the strontium citrate for osteoporosis clinical trial recently conducted by the University of California at Davis. Srontium citrate is sold as a health food supplement and is available in the U.S.A. without a prescription. Results should be available any day now.
I was on stronium citrate for over a year and lost bone denity. Of course everyone is diffrent.
To: Anonymous of 04/15/2011:
I am sorry to hear you lost bone density after more than a year on strontium citrate. Have you been checked for secondary causes of osteoporosis? For example, you could have a problem with your parathyroids and require surgery, or celiac disease or other malabsorption problems requiring special diets. Also, when you take strontium, you must also take calcium and magnesium separated by at least two hours. You must also make sure you have adequate vitamins D and K and essential fatty acids. There are so many possible factors involved in osteoporosis, and, as you said, we are all different.
Marielle Rebuffe Scrive was involved in the Fen-Phen lawsuit in the U.S. and, along with others, was found guilty. She is not an authority on ANY sort of medical condition. She is, in other words, a "quack."
To: Anonymous of 06/05/2012,
Dr. Marielle Rebuffe-Scrive is a biochemist who has spent many years in France and Sweden studying lipid metabolism and the factors that regulate distribution of fat to different regions of the body, particularly the effect of hormones on this process. A few years ago, she came to Yale University's department of psychology on a MacArthur Foundation fellowship to expand her research to include behavior as a factor in assessing the relationship between hormones, body fat distribution and health consequences.
Two Servier weight-loss products, both closely related to Mediator (a diabetes and weight-loss drug made by Servier and said to have caused thousands of deaths in France recently), were at the center of the fen-phen scandal of the late 1990s in the United States. The FDA banned all such weight-loss products after the Fen-Phen scandal in the U.S., and insider and political connections fail to get such drugs approved here.
All medications involve the weighing of benefits and risks, and even the most honorable evaluators make mistakes. There is plenty of blame to go around--the drug company and its executives and employees and the government agency that should have done a better job of overseeing drugs and looking out for the public welfare.
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