The Strength of Calcium
with the Purity of Genistein
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Science

Efficacy Profile

T-Score

A T-score is a measure of your bone density. Higher numbers usually mean stronger bone. The T-score is determined by comparing your bone to the bone of a large group of healthy 30 year olds. The difference between your result and the young average result is a T-score. If your bone is the same as the young average the result would be 0. If your result is lower than the young average, your T-score would be a minus number. A score between -1.0 and -2.5 indicates osteopenia. A score lower than -2.5 indicates osteoporosis.

A T-score is the result of a test that measures your bones using a type of X-ray. The gold standard test is called dual energy x-ray absorptiometrytry, commonly referred to as DXA. Every woman over 65 should have a DXA, but a pro-active approach is to have a DXA when menopausal symptoms begin or soon after a hysterectomy. This provides a baseline for future tests. You should have a follow-up DXA every year or two, or as recommended by your doctor. If your T-score remains stable, then the period between tests can be increased. If your T-score goes down significantly from one test to another, you should discuss some type of intervention with your doctor. Twice daily dosing with the genistein found in FOSTEUM PLUS has been shown to increase BMD at the hip and spine with continued use.

Hot Flashes

Frequency and severity of hot flashes

In a 12-month, prospective, randomized, double-blind, placebo-controlled study involving 247 symptomatic post-menopausal women, the genistein in Fosteum PLUS was shown to reduce the average number of hot flashes in 74% of the women reporting 5 or more hot flashes per day at baseline by approximately 50%. The severity of hot flashes was also reduced by 37.5% over the 12 month period. A significant reduction in hot flash number and severity was observed at the 1, 3, 6, and 12 month follow-up visits, with progressive improvement observed throughout the treatment period. Anecdotally, women have reported reductions in vasomotor symptoms within the first week of taking Fosteum PLUS.

Significant Reduction of Hot Flashes Over Time
Frequency: avg. -25% in 1 mo. to avg. -57% in 12 mo.
Severity: avg. -13% in 1 mo. to avg. -38% in 12 mo.

BMD

Bone mineral density (BMD) is a measure of the density of minerals (like calcium) in your bones. BMD is used to assess the overall quality of your bones. The better your BMD, the higher quality bone you have.

BMD change over three years

Everyone loses some bone mass with age, it’s a natural part of growing older. Our bones become thinner with time because our existing bone is broken down faster than our body can make new bone. Our bones lose calcium and other minerals to become less dense, more porous and lighter. This process leads to a state called osteopenia, which means our bones are weaker and at an increased likelihood of fractures.

Unless something is done, osteopenia may lead to osteoporosis, an even weaker state in which the likelihood of fracture is even higher. Osteoporosis can occur in men and women, and most people will develop some symptoms of osteoporosis in their lifetime. Osteoporosis is most common in post-menopausal women, because it occurs earlier in women than in men due to menopause. As men age, their incidence of osteoporosis increases.

Quality Bone

Quality bone. That is not a phrase that is often heard, but it is very important. What is ‘quality bone’? Bone is bone, right? Well, no, bone can be healthy and formed correctly or it can be of lower quality, osteopenic, and/or osteoporotic, faulty, full of old areas, and prone to breaking. Its structure is disorganized, or the crystals are too large. Studies have shown that even bone that is being treated with anti-resorptive therapies, like bisphosphonates, can be of inferior quality. Unfortunately for absolute answers, the only ways to evaluate bone quality are at autopsy or by performing a series of bone biopsies. Bone biopsy is extremely painful and very few women would be willing to have more than one performed for the good of science, so the next best thing is to look at the effects of various therapies on animal bone.

A study that tested rat bone compared the effects of the genistein in Fosteum PLUS against hormone replacement therapy (HRT), alendronate (Fosamax®, a bisphosphonate), and raloxifene (Evista®, a SERM). In this study one group of rats had their ovaries removed. Another group did not; this was the control group. Their bone would be expected to be normal. The rats that had their ovaries removed were then divided into four groups. One group was not treated; this group was the secondary control group, it showed how bad bone can get when estrogen is removed. Of the other three groups, one was treated with the genistein in Fosteum PLUS, one was treated with raloxifene, one was treated with alendronate, and the last group was treated with estrogen. After a period of time the rats were sacrificed and their bones were evaluated for histological structure. Of course, you expect the quality of the rat that did not have its ovaries removed to be normal, and it was. The rats that had their ovaries removed and were given no treatment had terrible quality bone; it was completely disorganized. The raloifene- and alendronate-treated groups showed varying bone quality, neither of them very good. Not only was the bone quality of the rats treated with the genistein in Fosteum PLUS better than the quality of any of the other treatments, but it was very close to the normal bone from the rats that had not had their ovaries removed. Based on this result, we can infer that the genistein in Fosteum PLUS causes the bone created by treatment to be of high quality. [Insert the graphic from the bone quality flashcards showing the histological cross sections of bone] The strength of the genistein-treated bone was significantly stronger than that of the untreated bone or the bone resulting from the other therapies. It strength showed in both crushing and breaking tests. (Reference: Bitto A, Burnett BP, Polito F, Marini H, Levy R, Armbruster MA, Minutoli L, Di Stefano V, Irrera N, Antoci S, Granese R, Squadrito F, Altavilla D. 2008. Effects of genistein aglycone in osteoporotic, ovariectomized rats: a comparison with alendronate, raloxifene and oestradiol. Br J Pharmacol. 155(6):896-905.)

There is another, indirect, way to estimate bone quality. The process of bone turnover creates very specific by-product proteins that we know are produced in the formation of bone, like bone-specific alkaline phosphatase (BAP), and osteocalcin (OC). The process creates other proteins that we know come from the break-down process, like N-terminal cross linking telopeptide (NTX), carboxyterminal cross-linking telopeptime, (CTX), pyridinoline (PYR), and deoxypyridinoline (DPD). These proteins can be measured in blood and/or urine.

A study of genistein against these other treatments showed that the genistein group had both increased BAP and OC and decreased NTX, CTX, PYR and DPD. So what does that mean?

Some drug treatments, like alendronate and raloxefene, reduce the break-down products from the bone turnover process, but they do nothing for the formation process. This was confirmed in the study. Genistein, however, does both. It reduces the by-products of the bone resorption process, and it increases the b-products of the bone formation process. This brings the bone turnover process back towards normal levels and results in more, healthy bone being formed.

[Bitto A, Polito F, Burnett BP, Levy RM, Di Stefano V, Armbruster MA, Marini H, Minutoli L, Altavilla D, Squadrito F. 2009. Protective effect of genistein aglycone on the development of osteonecrosis of the fermoral head and secondary osteoporosis induced by methylprednisolone in rats. J Endocrinol. 201(3):321-8.

Bitto A, Burnett BP, Levy RM, Polito F, Marini H, Di Stefano V, Armbruster MA, Minutoli L, Altavilla D, Sqadrito F. 2009. Genistein aglycone reverts glucocorticoid-induced osteoporosis and increases bone breaking strength in rats: A comparative study with alendronate. Br J Pharmacol. 156:1287-1295.

Bitto A, Burnett BP, Polito F, Marini H, Levy R, Armbruster MA, Minutoli L, Di Stefano V, Irrera N, Antoci S, Granese R, Squadrito F, Altavilla D. 2008. Effects of genistein aglycone in osteoporotic, ovariectomized rats: a comparison with alendronate, raloxifene and oestradiol. Br J Pharmacol. 155(6):896-905.

We are talking about using Fosteum PLUS for osteopenic or osteoporotic bone.

3-Year Progression

Now we’re going to discuss a particular study. This study showed that the genistein in Fosteum PLUS produced dramatic turn-arounds for most of the patients taking the product. Remember that this was a placebo-controled, double-blind study. Neither the doctors nor the patients knew who was receiving the real genistein and who was getting the placebo. For three years, these women followed the protocol, taking the capsules they were given and coming in for regular check-ups. At 1, 2, and 3 years after the start of the study, the women went through repeated DXA measurements and blood tests. Their study diaries were examined for side effects. The results were astounding.

At the start of the study, all of the patients were either osteopenic or osteoportic at either the lumbar spine, the femoral neck (hip),or both. About 31% of the patients were osteoporotic at the femoral neck. At the end of three years, in the placebo group, that number had increased to 70%. In just three years, 39% of the patients in the placebo group went from being osteopenic at the hip, to being osteoporotic. And remember, these patients were taking calcium and vitamin D3.

In the genistein treatment group though, the percentage of osteoporotic patients went from about 31% at the start to less that 10% at the end of three years. Yes, over 21% of the patients who were osteoportic at the start of the study improved sufficiently so that they were no longer classified as osteoporotic. That is a significant improvement. But that’s not all; 3% of the patients were classified as normal by the end of three years. They went from being osteoporotic or osteopenic at the hip, to being normal in just three years of treatment.

And the news at the lumbar spine was great, too. Sixteen percent of the patients in the placebo group were osteoporotic at the lumbar spine at start of the study, and 49% were osteoporotic at the lumbar spine at the end of three years.

In the genistein group, though, 14% were osteoporotic at the lumbar spine at the start and none of them were osteoporotic at the end of three years. Yes, none of them were osteoporotic at the end, they were either osteopenic or normal. About 17% of the patients assigned to the genistein group were normal at the lumbar spine at the start of the study, but about 65% were normal at that site at the end of the study period.

That means 14% went from being osteoporotic to being osteopenic or normal, and while only about 17% were normal at the lumbar spine at the start of the study, at the end an additional 48% were normal for a total of about 65%. Remember that there are no serious side effects from taking Fosteum PLUS, and no special protocols to follow. Take it with food or without, sitting, standing or lying down. It doesn’t matter, the product works no matter how you take it.

3-Year Progression/Regression vs Baseline

  • Why Fosteum Plus?
  • Why Medical Foods?
Why Fosteum Plus?
Fosteum PLUS is the only product available clinically proven to manage bone loss that offers calcium, phosphate and MK-7 in a single capsule along with genistein, citrated zinc bisglycinate and vitamin. Each ingredient is chosen for its specific action in helping to build quality bone.
Why Medical Foods?
Medical foods are an official Food and Drug Administration (FDA) category of products that must have therapeutic value based on recognized science. The name “medical foods” was chosen by the U.S. Congress. All medical foods must meet the distinctive dietary requirements of a particular disease.