Frequently Asked Questions about OsteoSun

General Information:

How is OsteoSun different from products already on the market?

Unlike other products on the market, the main ingredient in OsteoSun is premium-quality red yeast rice, which enhances the body's natural ability to restore bone mass and is scientifically proven to build new bone.

How does OsteoSun actually get into the system?

OsteoSun enters the bloodstream through the lymphatics (lymph vessels), which act as a portal between the intestines and the bloodstream. Although some of the product is initially metabolized by the liver, much enters the bloodstream, from where it can start its work on building bone.

Are the benefits of increased bone mass lasting or do they disappear if you stop taking OsteoSun?

The process of bone breaking down (resorption) is continuous, and is a natural process in the body. To counter the constant effects of resorption, it is recommended that OsteoSun users make it part of an overall healthy regimen that includes a balanced diet, regular exercise, and plenty of fresh water.

Why isn't calcium enough for my bones?

Calcium is effective in strengthening existing bone but does not generate new bone growth. The main ingredient in OsteoSun, red yeast rice, strengthens existing bone and is scientifically proven to form new bone as well.

Should I take calcium along with OsteoSun?

OsteoSun is not a source of calcium. So if you have been taking calcium supplements in order to address a calcium deficiency, you would want to continue that regimen.

Will your product help my cholesterol as well as my bones?

FDA regulations prohibit our making pharmaceutical claims about our dietary supplements, therefore OsteoSun is not promoted as a cholesterol-lowering supplement.

Has OsteoSun been known to strengthen teeth as well?

Since OsteoSun is formulated to help support bone health in general, the product could be very useful in strengthening the bone around the teeth (periodontics). However, at this point no studies have been conducted on this topic.

How does a consumer know if or when to adjust the daily amount, as the label suggests?

The usage suggestion is as follows: "1 capsule, or as needed, once or twice each day. You may wish to adjust this amount based on your individual needs." A healthy adult may consume as many as four capsules daily. However, since many factors may be involved, and individual needs and results can vary widely, we recommend that consumers consult with their health care adviser in this matter. While OsteoSun is designed to help maintain bone health, it is important to remember that we do not promote this or any other product as a cure or treatment for any disorder. Those with questions about dietary supplementation are encouraged to consult with a professional health care practitioner who is familiar with their health history and current nutritional needs.

Am I too old for OsteoSun to really make a difference?

OsteoSun's bone-strengthening benefits will aid adults of all ages. It is recommended that OsteoSun become a daily part of your lifestyle in adulthood.

What exactly is red yeast rice?

Native to China, red yeast rice is a fermentation by-product of cooked non-glutinous rice on which red yeast has been grown. Since 800 A.D., red yeast rice has been employed by the Chinese as a food and, in its dried, powdered form, as a medicinal agent. The active constituents in red yeast rice are: rice starch, protein, fiber, sterols, fatty acids, and monacolin K, dihydromonacolin, and monacolin I to VI.

Which strain of red yeast rice was used for OsteoSun?

Many strains of red yeast rice were tested, using different batches, suppliers, and fermenting methods, and the most bone-active strain was identified. As you can no doubt appreciate, formulations and processing methods are carefully devised by manufacturers and must be as carefully protected. Therefore, please know that some details, such as the particular strain of red yeast rice as well as specific figures and protocols for the laboratory experiments, are considered proprietary information that remains within the purview of the vendor to disclose.

Red yeast rice is not the kind of yeast that causes infections and other health problems for certain people; it does not ferment on animal tissue. This is a different strain that ferments on rice and is then dried and ground into a powder.

How does red yeast rice work to regenerate bone tissue?

Red yeast rice contains several different monacolins (phytochemicals) that activate the promoter of the bone morphogenetic protein 2 (BMP-2) gene. Osteoblasts are cells that are responsible for bone growth. Osteoblast differentiation is enhanced by BMP-2. The monacolins were identified from a library of 30,000 natural compounds as the most anabolic. Human bone cells exposed to monacolins show enhanced expression of BMP-2 messenger RNA. When tested in vivo (in a living body), the monacolins showed increased bone formation of two- to three-fold.

I've seen other supplements labeled 'red yeast rice.' Can I get the same results with these as with OsteoSun?

No. OsteoSun is derived from a patented technology which tested many different strains of red yeast rice. Only the strain that is the most bone-active is acceptable for OsteoSun. Not all strains of red yeast rice are the same. Red yeast rice contains many different phytochemicals that have a variety of health benefits. These include many kinds of isoflavones and monacolins. We have found that several of these phytochemicals are bone-active. Also, due to variations in the process of fermenting the yeast on rice, there are variations in the phytochemical content, which result in different levels of bone activity for different strains.

Some strains of red yeast rice are not bone-active at all. OsteoSun's proprietary screening process allows us to identify and include the most bone-active strain of red yeast rice.

Some Internet sites state that red yeast rice has been banned by the FDA. Is this true?

The FDA has ordered several red yeast rice retailers to stop selling their products because they were making pharmaceutical claims. Also, upon review of their certificates of analysis, their products were deemed to contain significant amounts of lovastatin, a drug for lowering lipids (cholesterol).

The red yeast rice strain found in OsteoSun contains many different monacolins and phytochemicals that are bone-active. It is not designed or marketed for lowering cholesterol, and we make no pharmaceutical claims whatsoever. Our product is completely legal and compliant with Dietary Supplement Health and Education Act (DSHEA) regulations.

In addition, in June of 2002, the U.S. Patent Office issued a Use Patent for red yeast rice, which means that the product can be used for a specific purpose (in this case, bone health). The patent number is 6,410,521.

Does OsteoSun contain sugar or carbohydrates?

The red yeast rice used in OsteoSun contains 0.8 gram carbohydrate, including sugar. Apart from naturally occurring sugars in the 50 mg of Omega Sun incorporated in the formula, OsteoSun has no other sugars. The flow agent is microcrystalline cellulose, which does not contain any sugar. As with all Simplexity Health products, we recommend that those with dietary concerns consult with their health care practitioner regarding nutritional supplementation.

Does OsteoSun contain ephedra or Ma Huang?

No.

Does OsteoSun contain gluten?

No.

Can you explain the OsteoSun label warnings in more detail?

Although the scientific studies of red yeast rice and the regular use by millions of individuals over thousands of years have shown it to be well-tolerated and to have no significant side effects, there are some areas about which it would be wise to be cautious. Health care professionals warn that you should not use either pharmaceutical statins (see below) or red yeast rice if you suffer from liver disease, or if you are pregnant or nursing.

“Keep out of reach of children.” OsteoSun is intended for use by adults. Red yeast rice is also known to lower cholesterol levels. Growing children need ample cholesterol for their healthy development. Although inadvertent intake of OsteoSun would in no way be harmful to a child, children should not use OsteoSun. Because the fetus needs cholesterol for healthy growth this caveat is also extended to pregnant women and women who might become pregnant. The red yeast rice strain found in OsteoSun is not designed or marketed for lowering cholesterol, but because there may be a slight cholesterol-lowering effect, we feel it is prudent to issue this warning.

“Discontinue use if you develop muscle pains or flu-like symptoms.” Rhabdomyolysis is a common disorder which may result from a variety of diseases, traumas, or toxic insults to skeletal muscle, including misuse of certain statin drugs (see next paragraph). Patients who develop rhabdomyolysis can have a number of symptoms but most often complain about muscle aches in their calves, back, or entire body. Red yeast rice has not been specifically linked to rhabdomyolysis, but because it contains monacolins, which are considered natural statins, we include the warning.

“Do not take if you have, or are at risk for, liver disease or have a history of liver disease.” Since OsteoSun is partially metabolized in the liver, the product is intended for use by people who have a healthy liver that is not compromised by disease. A liver that is damaged due to disease or alcohol may have a difficult time with the partial metabolism of OsteoSun that occurs in the liver. It should be remembered that all drugs may be associated with potentially serious side effects. Even though OsteoSun is not a drug, it does contain monacolins, which are chemically analogous to natural statins. Persons who have a history of liver disease or transplant surgery, or who take more than two alcoholic drinks a day, are advised to avoid substances that may further undermine liver function, such as statins and similar substances. (Please note that the monacolin amount in OsteoSun is anywhere from 10 to 50 times less than the related statin amount in the statin drugs.)

“Do not take if you have undergone organ transplant surgery or other major surgery.” Occasionally, myopathy (a general term referring to muscle disease) has developed in patients who have undergone statin therapy during hospitalization for major surgery. Therefore, it is prudent to withhold statins during such periods. Because the monacolins in OsteoSun are chemically analogous to statins, we include this caution.

Will OsteoSun interact with the medications I'm already taking?

Do not take red yeast rice if you are on a regimen of any of the following: High-dose niacin, atorvastatin, cerivastatin, fluvastatin, lovastatin, nystatin, pravastatin, or simvastatin.

OsteoSun is a safe, all-natural dietary supplement when taken according to directions. If you have questions regarding other specific medications, please consult your health care professional.

What problems are associated with the medications listed?

The medications listed are all cholesterol-lowering agents. Because OsteoSun also has a mild cholesterol-lowering effect, it could potentially interfere with the desired results of those prescription medications. Consumers who have questions about incorporating any dietary supplement into their nutritional regimen are advised to consult with their primary health care practitioner.

Can I take OsteoSun if I have had Hepatitis "B"?

Since OsteoSun is partially metabolized in the liver, this product is for people who have a healthy liver that is not compromised by disease. A liver that is damaged due to disease or alcohol may have a difficult time with the partial metabolism of OsteoSun. As with all Simplexity Health products, we recommend that those with known health disorders consult with a physician or alternative health care practitioner before adding any supplement to their nutritional regimen.

Were the experiments mentioned on the website performed on humans?

In vivo (in a living body) efficacy studies on the effects of OsteoSun’s primary ingredient, red yeast rice, on bone formation were performed on rodents. These experiments showed that OsteoSun’s red yeast rice is osteogenic in vivo. The particular in vivo model used is highly predictive of results in humans. These experiments were conducted after it was discovered that red yeast rice demonstrated striking bone formation in vitro (in a test tube). Observational studies by other groups on human subjects who have taken pharmaceuticals with similar active ingredients have confirmed a positive effect on bone mineral density and lower fracture risk. This is a revolutionary area in the natural supplement field, and research by reputable scientists is ongoing.

What is the amount of red yeast rice consumed by study subjects?

Each subject in the animal study consumed daily between 200 and 500 mgs of the same red yeast rice used in OsteoSun. Consumption regimens varied as researchers sought to identify the optimum daily amount. In the study, the bone mineral density (BMD) development was observed at 500 mg/day, determined as the optimum daily intake of red yeast rice. The OsteoSun maximum serving size of two capsules provides a total of 500 mg/day (400 mg red yeast rice and 100 mg Aph. flos-aquae).

Over what period of time was the bone mineral density experiment conducted?

The bone mineral density experiment described was an in vivo animal study that was conducted over a period of five weeks. It is recommended that users make OsteoSun a part of their daily health regimen. Positive results can be seen in weeks or months; but as indicated by this experiment, a dramatic increase in bone mineral density would require many months of usage.

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