Fosteum: A Natural Treatment for Osteoporosis?

Some of us can't take bisphosphonates, hormone replacement therapy, Forteo, Evista, or Calcitonin for the treatment of osteoporosis, so fosteum may be a solution.

What is Fosteum?

Fosteum is a medicinal food for the dietary management of osteopenia and osteoporosis.  Fosteum ingredients are: zinc, vitamin D3 (cholecalciferol) and genistein, a non genetically modified form of soybeans.  Each capsule contains genistein 27mg, zinc chelazome 20mg, and cholecalciferol 200 IU.

What is a Medicinal Food?

"Medicinal or Medical foods are foods that are specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone. They were defined in the Food and Drug Administration's 1988 Orphan Drug Act Amendments and are subject to the general food and safety labeling requirements of the Federal Food, Drug, and Cosmetic Act." (Wikipedia, 2007)

Can I Just Take Zinc, D3 and Soy?

According to Dr. Francesco Squadrito principle investigator of the study published in the Annals of Internal Medicine on the Effects of the Phytoestrogen Genistein on Bone Metabolism in Osteopenic Postmenopausal Women-A Randomized Trial, "To obtain the amount of genistein found in two capsules of Fosteum, one would have to consume 26 pounds of soybeans or over two gallons of soy milk each day.   Since no other product contains the same genistein as found in Fosteum, Dr. Squadrito urges caution in transferring the information in his paper to supplements purporting to contain genistein: Supplements contain much lower concentrations of genistein and have other, sometimes unidentified, compounds in addition to genistein (Business Wire, June 2007 )."

How is Fosteum Administered?

Fosteum is administered orally in capsule form taken with or without food every 12 hours.   You may take Fosteum with your favorite beverage, and there are no postural restrictions to follow, compared to other osteoporosis medications like Fosamax, Actonel or Boniva.

How Does Fosteum Work?

Fosteum works to slow bone loss and increase bone formation.   By normalizing these two mechanisms of bone turnover, Fosteum increases bone mass and may reduce the risk of fractures.

What Are the Possible Side Effects?

"A possible positive effect of Fosteum is a reduction in the number and intensity of hot flashes over time.   In clinical studies 70% of women who had hot flashes reported a reduction in the number and/or intensity of the hot flashes over time.   Negative effects include breast tenderness that goes away with time and mild to moderated GI symptoms including: upset stomach, nausea, stomach/abdominal pain and constipation (Fosteum FAQ's   Sept 2007)."

How is Fosteum Different?

Fosteum is unique because it can be taken by those women who are approaching menopause, going through menopause and for those who are post menopausal.   The majority of other treatment options available for osteoporosis are indicated for those who are post menopausal.   Some clinicians will prescribe other treatments that are intended for those that are post menopausal when they have a specific medical disorder, or a history of fragility fractures, that warrants the use of these drugs prior to menopause.

Testing on Genistein

The British Pharmacological Society did a study on ovariectomized rats to show the efficacy of genistein aglycone on bone mineral density, bone mineral content and bone strength.   In the study they compared genistein aglycone results with alendronate, estradiol, and raloxifene on bone loss and bone quality.  The authors conclude: "This study clearly shows that genistein aglycone, a well-known, but low concentration, soyabean isoflavone, was able to counteract the bone loss in an experimental model of established osteoporosis.  Not only did genistein aglycone increase BMD and BMC but the isoflavone also restored structure to osteoporotic bone as well or better than other well-accepted treatments." (British Journal of Pharmacology, Effects of genistein aglycone in osteoporotic, ovariectomized rats: a comparison with alendronate, raloxifene and oestradiol, August 11, 2008)

Is Fosteum Available Over the Counter?

Fosteum is only available with a Doctor's prescription, and it  has FDA approval.

Will My Insurance Pay for Fosteum?

Some insurance carriers cover Fosteum with an approximate co-pay of 40.00 to 60.00 dollars a month.   If your insurance doesn't cover this, contact Primus the manufacturer of Fosteum to get information on their discount program  that is available to all patients that don't have coverage regardless of your income level.   You may also request that your Doctor writes a Letter of Prior Authorization or for Medical Necessity, to see if your insurance will consider covering this treatment.

Who Can't Take Fosteum?

If you are allergic to any of the ingredients in Fosteum, you should not take it.   Check with your Doctor and the package insert for any listing on medications that may be contraindicated.

To summarize, speak with your clinician to see if Fosteum is a possible osteopenia or  osteoporosis  treatment for you, which only you and your clinician can decide, after careful consideration.