Ipriflavone is a Major Part of the Osteoporosis Solution:
An interview with Carl Germano, R.D.

by

Richard A. Passwater, Ph.D.

According to the National Institutes of Health, osteoporosis is a major health problem for 28 million Americans, 80% of whom are women. Today in the U.S., ten million persons already have osteoporosis and 18 million more have low bone mass, placing them at increased risk for this disease. This translates into -- according to the Osteoporosis and related Bone Diseases Division of the National Resource Center – one out of every two women and one in eight men over 50 will have an osteoporosis-related fracture in their lifetime. Osteoporosis is responsible for more than 1.5 million fractures annually in the U. S., including 300,000 hip fractures, approximately 700,000 vertebral fractures, 250,000 wrist fractures, and more than 300,000 fractures at other sites. The cost of these fractures, in terms of national direct expenditures is $14 billion each year. The indirect cost is impossible to measure as many hip fractures lead to hospitalization that results in pneumonia and thence death!

We hear a lot about increasing the amount of calcium in the diet. On August 13, 1997, the Institute of Medicines’s Food and Nutrition Board reported that people need more calcium and magnesium than indicated by the former RDA. The RDA panel that reviewed the research on calcium and related compounds recommended that Americans and Canadians at risk of osteoporosis should consume between 1,000 and 1,300 milligrams of calcium per day. That’s fine, but bones are not just calcium sticks. Bones are living tissues composed of a protein matrix consisting mostly of collagen to provide a soft framework, and calcium phosphate complexed with calcium hydroxide to form a composition similar to the mineral hydroxyapatite to add hardness and strength. The combination of about 35 percent protein and 65 percent mineral compounds make bones strong, but yet flexible enough to withstand many stresses. Bone tissue is constantly being exchanged. Old bone is removed (resorption) and new bone is being replaced. It has been estimated that about 700 milligrams of calcium enters and leaves bone tissue daily. Calcium makes up only about 20 percent of bone tissue. Trace minerals, vitamins and hormones or hormone-like isoflavones are just as important to the process of bone formation and resorption as calcium.

In this chat with my colleague Carl Germano, R.D., we will discuss ipriflavone and the prevention and treatment of osteoporosis. Next month, I will chat with Drs. Mario Calomme and Dirk Vanden Berghe of the University of Antwerp (Belgium) about the importance of silicon to bone health and health in general. Carl Germano, RD, CNS, LDN is a certified nutritionist with 22 years experience in clinical practice and product development. He is the Vice President of Product Development for Solgar where he has been instrumental in the development of many innovative nutritional products. Carl is an Adjunct Professor in Nutrition at New York Chiropractic College, coauthor of The Brain Wellness Plan and author of The Osteoporosis Solution.

Passwater: Your new book directed at osteoporosis prevention and treatment is very timely, especially since so many people are asking about ipriflavone.. What led you to go from brains in The Brain Wellness plan to bones in The Osteoporosis Solution?

Germano: My attention to osteoporosis was predicated on the staggering statistics of the disease, the misinformation and lack of options given to women today. The disease affects over 25 million Americans and the number could easily top 40 million over the next two decades in the United States. Additionally, a comprehensive, effective treatment for osteoporosis has long eluded traditional medical professionals. Calcium alone has been proven to have severe limitations and conventional drug regimens such as estrogen therapy can have severe harmful effects. With The Osteoporosis Solution book, I try to outline the latest developments in nutritional therapies in an easy-to-understand guide that offers alternatives. The most exciting news comes from new dietary supplements that can dramatically improve bone health - ipriflavone and isoflavones. With numerous clinical trials on ipriflavone, increasing bone density in a manner similar to estrogen without the deadly side effects can be attained. There is also an extensive review of the importance of minerals and vitamins above and beyond calcium, the importance of exercise and a wonderful collection of dairy free, bone building recipes.

Passwater: OK, lets begin with the basics. Most people think of our bones (skeleton) as a mass of dead hard mineralized tissue. Please give our readers a better description of the live bone system.

Germano: While our skeleton is the basic foundation of support and protection, the bones that make up this organ system are not a lifeless collection of minerals stuck together. Essentially, bone is a dynamic organ system composed of both hard and soft tissue. Additionally, bone is an integral part of the human metabolism, not an isolated mechanical structure, and it affects many bodily systems and functions.

Passwater: You mentioned bone breakdown and formation, are these processes that normally take place within our skeletal system?

Germano: Absolutely, despite its appearance, bone is a dynamic living tissue that supports human form and function. The delicate balance between bone breaking down (via specialized cells called osteoclasts) and bone building-up (via cells called osteoblasts) and hormones that regulate their activity underscores bone’s importance to all body systems.

Passwater: What is the difference between osteoporosis, osteopenia and osteomalacia?

Germano: Osteoporosis is a progressive decrease in bone mass and density, causing skeletal weakness and brittle, fragile bones that are subject to breaking. Osteopenia is a reduction of bone mass due to an imbalance between bone breakdown and bone formation. In osteopenia, the rate of breakdown is higher than formation, resulting in demineralization and, ultimately, in osteoporosis. Lastly, osteomalacia is a softening of bone in adults caused by a failure of normal bone calcification, primarily as a result of vitamin D deficiency.

Passwater: You did a superb job in your previous book, The Brain Wellness Plan, with revealing the intricate relationship between our brain and immune system. In your new book, The Osteoporosis Solution, you again enlighten the reader about the importance between the immune system and now, the skeletal system. Could you tell us more?

Germano: When we think of the immune system, we generally visualize busy white blood cellsprotecting us from pathogens. Well, we have come a long way in our understanding of the immune system and how it communicates and influences every organ system in the body, including the skeletal system. The immune system communicates with our bones through chemical messengers called cytokines. In general, cytokines can be either pro-inflammatory agents (amplifying the immune response) or anti-inflammatory agents (calming the immune response). Cytokines are able to control how long, how fast and in what part of the body the immune system acts. When it comes to osteoporosis, we now know that certain cytokines influence the activity of osteoblasts and osteoclasts, directing them to build-up or break down bone. The pro-inflammatory cytokines such as interleukin-1, interleukin-6, interleukin-8, interleukin-12 and nitric oxide can promote osteoporosis by turning on and assisting osteoclasts in their destructive roles.

Passwater: Since cytokines can play a part in prevention or progression of osteoporosis, are there any nutrients that can tame the inflammatory cytokines?

Germano: Yes, Cytokine Modulators such as vitamin E, vitamin D, quercetin, curcumin, boswellia, Pycnogenol® and the omega-3 fatty acids can reduce the destructive effects of inflammatory cytokines that breakdown bone. Additionally, a new dietary supplement called ipriflavone has been shown to decrease the activity of some of these cytokines as well as effectively increase bone density

Passwater: Osteoporosis is a serious illness that affects many people yet we do not hear as much about it as other debilitating diseases. Could you give us some of the facts as it relates to the seriousness of this disease?

Germano: More than 75 million people worldwide have some form of osteoporosis. More than one million fractures per year in the United States are thought to be a result of osteoporosis. The three most common sites of fracture are the vertebrae, the wrists and the hips. The risk of hip fracture in older women is greater than the risk of all female cancers combined. Additionally, osteoporosis substantially increases the risk of death in the elderly within six months of an injury that involves a fracture.

More than 50% of American women currently over seventy years old will suffer spinal compression as a direct result of osteoporosis, a severely painful collapse of the vertebrae that can cause paralysis, as a direct result of osteoporosis. The disease is seriously debilitating and may be fatal and the social cost of osteoporosis is staggering: almost 10 billion dollars yearly. It’s not hard to see why osteoporosis is considered a disease of epidemic proportions.

Passwater: What are some of the misconceptions about osteoporosis?

Germano: There are several, but here are the four biggest misconceptions.

1) I’m too young to get osteoporosis - Osteoporosis tends to develop silently, with few symptoms. It can develop in women in their twenties and thirties and it’s not unusual for women in their forties to start feeling its effects.

2) Only women get osteoporosis - While it is true that most osteoporosis victims are postmenopausal women, men are far from immune. It’s estimated that almost two million American men have osteoporosis and another three million are at risk. Nearly one third of elderly American men will suffer hip fractures, and of these, a third will die within a year.

3) I drink lots of milk - I won’t get osteoporosis - It is true that calcium is important for bones, but calcium is only one of many minerals and nutrients that affect bone health. Milk is certainly not the best source of calcium anyway!

4) If I take calcium supplements - I won’t get osteoporosis - Again, calcium is important, but neglecting the other nutrients necessary for healthy bones is not going to help with prevention. Additionally, if other important factors are not in place including exercise, diet and lifestyle, all the calcium in the world won’t protect your bones.

Passwater: We hear so much about estrogen replacement therapy, what are your thoughts?

Germano: Without a doubt, estrogen replacement is very effective as it plays a vital role in the development and treatment of osteoporosis. Estrogen is known to decrease the rate of bone breakdown, blocks the effects of certain hormones such as PTH that break down bone and estrogen binds to the receptors on osteoclast cells preventing them from functioning normal. Therefore, as the levels of estrogen significantly drop the risk for osteoporosis increases. The overriding problem is that in order for estrogen to affect bone density, levels greater than 0.625mg must be used. Levels at/or below 0.625mg is considered "low dose" estrogen therapy and only address menopausal symptoms - this level does nothing for bone density. Levels above 0.625mg are effective to treat osteoporosis but significantly increases one’s risk for certain cancers. Therefore, I believe estrogen, by itself, is not a viable option for women given that we now have alternatives such as ipriflavone and isoflavones.

Passwater: You mention the role of progesterone - the forgotten hormone. Could you explain?

Germano: Dr. John Lee presented the hypothesis that natural progesterone and not estrogen is the missing factor in osteoporosis as published in Medical Hypothesis 1991. He was able to demonstrate that natural progesterone was extraordinarily effective in reversing the osteoporotic process without the use of estrogen. It seems that progesterone works to influence the bone building process by stimulating osteoblasts independent of estrogen. Today, taken with or instead of estrogen, progesterone is beginning to be recognized and used to treat osteoporosis. Additionally, it seems that adding progesterone to estrogen therapy can significantly enhance the cardioprotective effects of lowering LDL’s and raising HDL’s. With all of this, more research needs to be conducted and more physicians need to be willing to review this intriguing work.

Passwater: Would you review the most common drugs used for osteoporosis and their side effects?

Germano: Gladly. Perhaps, the following table will help organize my comments.

Drug Action Side Effect
Estrogen Can reduce incidence of fracture, enhance osteoblast activity, increases bone density Increases risk of breast
cancer, endometrial
cancer and blood clots
Calcitonin  Increases absorption of calcium, inactivates osteoclasts, reduces risk of fracture Oral form causes nausea, flushing and diarrhea
Nasal form causes dryness of the nasal lining, nosebleeds and itching
Fosamax Interferes with the function of osteoclasts, reduces the risk of fracture, increases bone density Causes GI disturbances, accumulates in the skeleton, long term safety in question
Raloxifene Increases bone density  Causes hot flashes
Sodium Fluoride Increases the number of osteoblasts Creates poor quality, fragile bone
Can increase the risk of fracture
Causes GI disturbances
May cause bone cancer
Calcitriol Increases absorption of calcium Causes elevated calcium in the blood
Increases risk of kidney stones
Tamoxifen Similar effects on bone to those of estrogen Increases risk of uterine cancer
Tribolone Slows the rate of bone breakdown Decreases HDL levels and increases the risk of heart disease

 

Passwater: The table drives home the point that the various options are not as viable as one would like. Is there a solution for women and men to deal with osteoporosis?

Germano: While traditional approaches have their limitations, they should be combined with safer complimentary nutritional therapies and appropriate lifestyle changes in diet and exercise. This is especially important since one of the most important nutritional agents on the market today is ipriflavone - a safe alternative to estrogen. With numerous clinical trials behind it, ipriflavone has shown to inactivate certain destructive cytokines and increase bone density in a manner similar to estrogen, yet without estrogenic activity.

Passwater: Well, you keep mentioning ipriflavone and it seems outstanding as a replacement to estrogen. Can you elaborate?

Germano: Ipriflavone is derived from the class of important phytonutrients called isoflavones, which are naturally found in soy. Ipriflavone is widely accepted around the world and is a registered medication for the treatment of osteoporosis in Europe, Japan and Argentina. It’s chemical structure is similar to estrogen and consequently, the body uses it in much the same way to help reduce bone loss. With numerous human trials behind it, ipriflavone has been shown to be an effective agent for the treatment of osteoporosis and works in the following ways:

1) inhibits bone breakdown and enhances bone growth by boosting the activity of osteoblasts

2) may help in the repair of fractures and increase bone matrix proteins

3) may enhance the secretion of calcitonin, the primary bone building hormone

4) works primarily on bone tissue and not on other organs the way estrogen does

5) helps relieve pain associated with bone disorders

6) works better than calcium or calcitonin in maintaining bone mass

7) works as an excellent adjunct to either low dose estrogen, calcitonin or low dose calcium supplements

These are just a few key points about this fantastic dietary supplement. I thoroughly review most of the literature and provide a synopsis of the most important studies for review in The Osteoporosis Solution book.

Passwater: With all the significant results of the human trials behind ipriflavone, this could well be one of the most important dietary supplements to come to our market. The most pressing question is "Is it safe"?

Germano: Ipriflavone’s dramatic effects on osteoporosis have been demonstrated in numerous human clinical trials. The best part is that ipriflavone consistently showed no significant side effects. A major paper rounded up the data on safety and efficacy of ipriflavone in 60 clinical studies performed in Italy, Japan and Hungry and involving more than 2,769 people. His paper looked at long-term (two year) reactions to ipriflavone and found no significant side effects. The few side effects that were noted included gastrointestinal complaints (bloating and constipation) which were attributed to the combination of ipriflavone with calcium. Since gastrointestinal complaints are common, well recognized complaints of calcium supplements, the authors attributed the minor side effects to calcium rather than ipriflavone. The only effect that was noted that deserves attention is the possibility that ipriflavone may raise liver enzymes. This is an effect similar to what niacin does. The possibility exists that some of the people in the studies were elderly and on several medications which may contribute to raising liver enzymes. Therefore, if you are on medications and want to take ipriflavone, have your doctor monitor your liver function. In The Osteoporosis Solution book, I outline a nutritional protocol to support liver function while on any medication.

Passwater: Most physicians do not know about ipriflavone and have only emphasized taking calcium supplements to nutritionally treat osteoporosis. This is certainly shortsighted, what are the other nutrients we need to concentrate on?

Germano: From a diet and dietary supplement standpoint, the following recommendations are detailed in The Osteoporosis Solution book and represent a comprehensive approach to preventing and treating osteoporosis.

Diet

Avoid sugar, caffeine and excess sodium - all can increase the excretion of calcium
Choose the right types of fat such as omega 3’s (fish), avoid saturated fats
Avoid excess protein intake
Consume more soy and soy containing foods for their beneficial phytoestrogen content
Avoid alcohol

Important Dietary Supplements

Calcium, Magnesium, Silicon, Vitamin D, Vitamin K, Boron, Zinc, Copper, Vitamin C, homocysteine modulators such as Folic Acid, Vitamin B12 and Vitamin B6

Passwater: This has certainly been a re-education on bone health and osteoporosis. While I know you have a lot more to say, is there one last message you would like to leave us with?

Germano: How well we keep our bones and heal from osteoporosis strongly depends upon how well you educate yourself about its causes, effects and treatments. The Osteoporosis Solution will serve as a resource that lets you take charge of your bone health - to improve the quality of your life and the lives of those you love. Most importantly, I provide alternatives to present drug treatment and a comprehensive nutritional protocol that can be immediately implemented. You don’t have to settle for what is being offered to you.

Passwater: Thank you for sharing the main focus of your new book with us.

Copyrighted 1998 by Whole Foods magazine , Whole Foods Incorporated. Reprinted with the permission of the copyright owner. No distribution of any kind permitted without the permission of the copyright owner or Solgar Vitamin & Herb Co., Inc.