Interview With MaryAnn Armbruster Ph.D. on Her Work and Treatment With Fosteum®

Pam Flores Health Guide December 16, 2009
  • Today I'll be interviewing my friend MaryAnn Armbruster, about her work on Fosteum® and her treatment with it for bone loss. MaryAnn will dispel some misconceptions about this treatment and explain how this medical food works. Welcome MaryAnn!

     

    MaryAnn Armbruster's Bio:

    MaryAnn Armbruster is a Clinical Chemist with more than 20 years in the in vitro diagnostics and pharmaceutical industries after leaving the clinical laboratory.  She has a B.A. in Chemistry from Georgia College and obtained her Ph.D. from Purdue University.  She worked for Sanofi Pasteur in the U.S. and in France, and for DPC, Iris Diagnostics and Primus Pharmaceuticals.  She worked in Sales, International Product Management, Marketing, Market Development, Clinical Affairs, Technical/Clinical Writing and Customer Training.  She is a Master Gardener and lives in Arizona with her husband and three dogs.

     


     

     

    I understand that you're taking Fosteum for osteopenia; how long have you been on it and how are you doing?  Have you seen an increase in bone mineral density?

      

    Yes, I have been on Fosteum for 2 1/2 years.  I am doing very well.  My bone density increased significantly from my 2006 DXA to the 2008 DXA.  My hip went from -0.9 to +0.5.

     

    Fosteum is a medicinal food; could you explain what that means to our readers and how often you take it?

      

    Medical food is a term coined by the FDA.  It has a very specific definition and specific requirements to be included in the category.  It is not a dietary supplement and it is not a drug.  The capsule is taken twice a day.  Since it can be taken with or without food it's pretty easy to take.  I do mine with coffee in the morning and again sometime after dinner.

     

    What are the ingredients in Fosteum, and how do they work?

     

    The ingredients in Fosteum are genistein aglycone, citrated zinc bisglycinate and cholecalciferol (vitamin D3).  Studies have shown that genistein improves bone density and that zinc makes the genistein work better.  Vitamin D is well known to improve bone health, as well as being used in many other functions at the cellular level.

     

    Can you just take zinc, vitamin D3 and soy instead of Fosteum?

     

    Well, I guess you could try to come up with a similar combination from over the counter products (OTC), but first, let me say that there's no way I will take unfermented soy.  The fermentation increases the concentration of the desirable isoflavones and reduces some of the undesirable ones.  The zinc chosen for Fosteum has a better absorption profile than most other zinc compounds.  I know that there is a OTC product that claims to have the same ingredients.  I have a problem with that, and I won't even mention patent infringement.  Fosteum is a medical food.  One of the requirements of the classification is that the product be used to treat a recognized disease state and that it be given under supervision of a medical professional.  Every Fosteum bottle comes with full Prescribing Information (PI).  Included in the PI are such things as Contraindications, Drug Interactions, etc., all based on scientific studies.  There are people who should not take Fosteum.  The OTC product does not address any of these potential problems leaving the consumer unaware and vulnerable.

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    Do you feel that Fosteum is a safe and superior alternative to the main stream osteoporosis medications and why?

     

    I do feel that Fosteum is safer than the main stream alternatives.  There are some people who have nausea and/or constipation.  These may stop with continued administration.  A few percent of people taking the product in clinical studies had nausea sufficient to make them stop taking the product.  Even so, nausea, which goes away when you stop taking the product, is greatly preferable to deep bone and muscle pain, esophagitis/esophageal ulcers or osteonecrosis of the jaw.  It's a matter of degree.

     

    According to the research done by, Dr. Francesco Squadrito et al. in the study titled: "Effects of Genistein Aglycone in Osteoporotic, Ovariectomized Rats: a Comparison with Alendronate, Raloxifene and Oestradiol (Squadrito et al., 2008)." Fosteum affects both resorption and formation markers, could you explain this concept to the readers and the impact this has on bone loss and bone growth?  Why are bone marker tests important in evaluating the efficacy of treatment, for osteoporosis?

     

    This is a compound question; it involves explaining the process of bone formation and maintenance, defining resorption and formation markers and explaining their clinical use and how they were used in a particular study.  I will try to make it as simple as possible. 

     

    First, the formation and maintenance of healthy bone is a very complicated process.  It involves a large variety of cells, receptors, ligands, enzymes, minerals, etc. that control the formation and resorption of bone matrix.  To make it as simple as possible, think of a teeter-totter.  If the people on both ends are of equal weight, the teeter-totter is level, or in bone terms, the resorption and formation are equally matched; bone is resorbed and formed at equal rates so there is no net change.  If, however, one person on the teeter-totter is heavier than it other, it will not be level.  In osteoporosis terms, when the bone resorption activities outweigh the bone formation activities, the overall result is bone loss leading to osteoporosis.

     

    Next let's talk about markers.  In clinical science some things can be measured directly and with great accuracy.  Weight, height, blood glucose are all things that can be measured directly with no or minimal invasion.  Other things cannot be measured directly without performing serious invasive procedures.  The amount of plaque in your arteries, for example, cannot be measured directly.  Your physician may, however, measure your serum cholesterol, which is considered a 'marker' for the degree of arterial plaque.  It's a simple blood test, relatively non-invasive and inexpensive.  So a 'marker' is an indirect measurement of a process or condition in the body that can be measured with less danger to the patient and usually less cost.

     

    So, what did the study say?  Squadrito's study, on which I am a co-author, used bone markers, as well as direct measurements, to show the relative activities and effects of Fosteum compared with the effects of alendronate (Fosamax®), raloxifene (Evista®) and oestradiol (estrogen replacement) in rats who were osteoporotic and compared those results to each other and to normal rats.  Because the study used rats, direct measurements of cell formation and organization (histology), femur breaking strength and femur crush strength were possible.  Markers were used because they can be correlated with markers in humans.  Bone mineral density (BMD), as well as serum calcium and phosphorus were measured.  These are direct measurements.  The markers used were markers for bone formation and for bone resorption.  The bone formation markers used were bone-alkaline phosphatase and osteoprotegerin; the bone resorption markers were collagen C-telopeptide and soluble receptor activator of NF-kB ligand.  (See what I mean about complicated?)  So let's just say that we measured two markers of bone formation and two markers of bone resorption.  In all cases, both in direct measurements and indirect markers, the genistein-treated rats showed histology (cell organization), breaking strength, BMD, and bone formation markers as good or better than any of the other treatments and very close to the normal.  In the bone resorption markers, the genistein-treated rats showed reduction of these markers to a greater extent than any of the other treatments.

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    In humans, bone markers can be measured and can show changes much more rapidly than DXA can.  It takes one to two years for sufficient bone change to actually show on a DXA; bone markers can show a change in the rate of bone formation or resorption within a matter of 6 to 8 weeks.

     

    Can you explain how Fosteum out-performed Alendronate (Fosamax), Estradiol (estrogen replacement), and Raloxifene (Evista) that's mentioned in the above study?

      

    The most logical reason for Fosteum's excellent performance is the fact that it addresses both sides of the equation, formation and resorption.  In bone loss, the rate of resorption may be dramatically increased, and the rate of formation cannot keep up with loss.  Most of the standard medications treat only the resorption side, reducing the rate of resorption.  Fosteum reduces the rate of resorption, too, but also increases the rate of formation, bringing the overall process back to a more normal level.

     

    Many professionals claim that soy, an ingredient of Fosteum, interferes with the absorption of thyroid replacement medications, is this true and how does this happen?

      

    If one reads the prescribing information for Synthroid®, it states, "Soybean flour (infant formula), cotton seed meal, walnuts, and dietary fiber may bind and decrease the absorption of levothyroxine sodium from the GI tract".   The genistein aglycone in Fosteum has been tested and found to contain less than 0.5 mg of other soy compounds (less than 0.000018 ounces).  This small amount should not be a problem, especially if the two products are taken at different times. 

     

    On a similar note, the Synthroid prescribing information also states, "Agents such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine sodium tablets.  Therefore, levothyroxine sodium tablets should not be administered within 4 hours of these agents."  Fosteum does contain a small amount of calcium, as well as some magnesium, a related mineral; therefore, I would suggest separating the thyroid medication and the Fosteum capsule by the recommended 4 hours.  For example, one might take the thyroid medication on waking and the Fosteum with lunch and before bed.

     

    Can cancer patients take Fosteum for bone loss due to hormone ablation therapy?

     

    Fosteum is contraindicated in patients who have or have had cancers of the reproductive organs.

     

    You've told me that you have fibromyalgia and you're hypothyroid, is Fosteum contraindicated in these medical disorders?   Does this supplement have any impact on these two medical issues?

     

    Clinical studies had no reports of altered thyroid function in patients taking Fosteum.  Personally, I required no change in my thyroid medication dosing and have noticed no impact on my fibromyalgia symptoms.  Please note that I am mildly hypothyroid.  Physicians and patients who have concerns can obtain the latest information from the manufacturer.

     

    According to the manufacturer of Fosteum, this medical food may reduce the incidence of hot flashes; have you had this experience and if so could you explain how this treatment works for this problem?

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    Since the underlying cause(s) of hot flashes is/are not clearly delineated, I could not begin to explain why Fosteum may reduce them.  I do know that in the clinical studies, hot flashes, along with any other symptoms or side effects, were noted by the patients in their journals.  The patients were never told that they were being studied for hot flashes specifically.  On studying the journals, it was noted that a significant number of patients who had hot flashes at the beginning of the study were reporting fewer of them over time.  Personally, I have been on estrogen replacement therapy since I was 36.  I have not changed my medication since beginning Fosteum.

     

    Have you had any side effects from Fosteum, and if so, what were they and how did you manage them?

      

    Simple answer, no.  I, personally, have had absolutely no side effects from Fosteum.  There's a small percentage of people who report nausea of varying degrees and some report constipation.

     

    Is Fosteum taken indefinitely, or can a patient stop taking it at some point?

     

    Indefinite use is a possibility, just as with the traditional treatments.  To the best of my knowledge, there are no studies to indicate that it should be discontinued after a given period.  It is really a decision between patient and health care provider and would depend on the individual situation.

     

    What are your plans for the future, will you continue to take Fosteum?

      

    Yes, as of now I do plan to continue to take Fosteum. 

     

    Thank you MaryAnn for a very informative interview!