The Strength of Calcium
with the Purity of Genistein
Pay no more than $45 on every Fosteum prescription

Healthcare Professionals

Pharmacists

Product Background

  • Usage - For the clinical dietary management of the metabolic processes of osteopenia and osteoporosis.
  • Ingredients - Each FOSTEUM PLUS capsule contains 200 mg of dicalcium malate, 300 mg of pentacalcium hydroxide triphosphate, 70 mg of phosphate, 27 mg of genistein aglycone (genistein), 20 mg citrated zinc bisglycinate, 90 µg of vitamin K2 as pure trans-menaquinone-7 crystals, and cholecalciferol equivalent to 400 IU vitamin D3.

    FOSTEUM PLUS contains the following ingredients as excipients: micro-crystalline cellulose, magnesium stearate and silicon dioxide. The capsule is bovine gelatin, with chlorophyll and titanium dioxide for the capsule color. FOSTEUM PLUS does not contain fructose, glucose, sucrose, lactose, gluten, maltodextrin, tree nuts, peanuts, soy, flavors or products of animal or seafood origin.
  • Fosteum PLUS is manufactured under cGMP standards.
  • Administration - take one capsule every 12 hours under a physician's supervision. Safe to be taken with or without other foods or beverages. There are no postural restrictions on administration.
  • How Supplied - Fosteum PLUS is supplied in bottles of 60 capsules is dispensed by prescription only. FOSTEUM PLUS does not contain fructose, glucose, sucrose, lactose, gluten, maltodextrin, tree nuts, peanuts, flavors or products of animal origin. Fosteum PLUS is suitable for vegans.
  • FDA Regulated Product Class - Medical Food, a prescription product intended for an osteopenic or osteoporotic patient (not a drug or dietary supplement).
  • Distribution - Nationwide by prescription at retail pharmacies. National wholesaler order: Amerisource Bergen (Amerisource: 5006101; Bergen: 600421); Cardinal (399-04-62); McKesson (1638196)
  • Promotion - Only via education and detailing to medical professionals (MD/DO/PA/NP's).
  • Patient Education - Provided via website, and in-office patient materials

Therapeutic Category

  • Osteopenia and osteoporosis are diseases of reduced bone mass. They differ only in severity. Osteopenia, T-score -1.0 to -2.5, precedes osteoporosis, T-score -2.5 or worse. Higher T-score with fracture from minimal trauma is also classified as osteoporosis.
  • Osteoporosis affects 10 million Americans, the vast majority postmenopausal women, and is responsible for over $18 billion in healthcare costs annually.
  • 34 million Americans have osteopenia which may lead to osteoporosis. These numbers are increasing with the aging of the population.
  • Historically, HRT was used to improve bone health of postmenopausal women, but the results of the Women's Health Initiative dramatically reduced the number of women willing to take these drugs.
  • Often, physicians believe that calcium+D is the only option for osteopenic patients because the drugs approved for treatment of osteoporosis may have significant side effects.
  • In double-blind, placebo-controlled randomized clinical trials, Fosteum PLUS was shown to increase BMD at the hip and spine by approximately 3% per year compared to baseline in osteopenic and osteoporatic postmenopausal women.
  • In a double-blind, placebo-controlled clinical trial Fosteum PLUS was shown to reduce the number and severity of hot flushes over a 12 month period.

Product Benefits

  • Efficacy - Fosteum PLUS manages the distinctive nutritional requirements of osteopenia and osteoporosis by restoring the normal balance of bone turn-over in the following ways:
    • The genistein in Fosteum PLUS inhibits the activity of osteoclasts thereby reducing bone resorption.
    • At the same time, the genistein in Fosteum PLUS increases the recruitment, number and activity of osteoblasts thereby increasing bone formation.
    • The zinc in Fosteum PLUS enhances the action of genestein and aids in bone mineralization, and the form chosen for Fosteum PLUS is more easily absorbed from the intestine.
    • The cholecalciferol in Fosteum PLUS increases calcium absorption and bone mineralization.
  • Safety - The ingredients in Fosteum PLUS have a long history of safe use
    • GRAS ingredients - Generally Recognized As Safe (GRAS) - the highest FDA safety standard applied to food ingredients. GRAS indicates that the product is generally recognized by qualified experts as safe for its intended use.
    • In published clinical studies, the genistein in Fosteum PLUS showed no adverse effects on endometrial thickness or vaginal cytology.
    • In published clinical studies, side effect rates were only slightly higher than placebo. The most common side effects were dyspepsia and constipation. In safety and toxicology studies (human, animal and in-vitro), serological, hematological and histological measures were comparable to placebo.
    • In published clinical studies, the genistein in Fosteum PLUS showed positive effects or no effect on markers of cardiovascular safety.
  • Menopausal Symptoms - Fosteum PLUS reduces the number and severity of hot flushes.
  • Clinical & Scientific Support - The beneficial actions of Fosteum PLUS and its ingredients are supported by numerous studies. Some representative results are shown below:
    Table 1. Mean Percent Change in BMD at 12 Months vs. Baseline
    SITE GENISTEIN (n=30) HRT (n=30) PLACEBO (n=30)
    Femoral Neck 3.6% 2.4% -0.65%
    Ward's Triangle 4.0% 3.0% -0.36%
    Lumbar Spine 3.0% 3.8% -1.6%
    Table 2. Mean Percent Change in BMD over 24 and 36 Months (Subgroup Analysis)
    SITE 24 months vs. baseline 36 months vs. baseline
    GENISTEIN (n=71) PLACEBO (n=67) GENISTEIN (n=71) PLACEBO (n=67)
    Femoral Neck 6.2% -4.9% 8.0% -7.7%
    Lumbar Spine 5.7% -8.7% 8.8% -11.7%
    Table 3. Mean Change in BMD over 12 and 24 months
    SITE GENISTEIN (n=198) PLACEBO (n=191)
    BASELINE 12 MOS 24 MOS BASELINE 12 MOS 24 MOS
    Femoral Neck g/cm2

    0.667 0.683 0.702 0.674 0.659 0.638
    Lumbar Spine g/cm2 0.842 0.866 0.891 0.837 0.807 0.784
    Table 4. Mean Percent Change in Bone Markers at 36 Months vs. Baseline
    BONE MARKERS GENISTEIN (n=71) PLACEBO (n=67)
    BAP +48.1% -1.0%
    PYR -19.1% +7.3%
    DPYR -15.5 0.0%
    Table 5. Number and Severity of Hot Flashes per Day
    TIME GENISTEIN (n=125) PLACEBO (n=122)
    Number Severity Scale 1-4 Number Severity Scale 1-4
    Baseline 4.4 2.4 4.2 2.3
    1st month 3.3 2.1 4.4 2.4
    3rd month 2.6 1.8 4.7 2.4
    6th month 2.4 1.7 4.7 2.3
    12th month 1.9 1.5 4.2 2.2

Reimbursement Status

  • Fosteum PLUS Coverage: Mostly reimbursed on Tier-3 (co-pay $40-60 per prescription). Individual plans may vary.
  • Cost Savings: According to the 2004 Surgeon General's Report the cost for osteoporosis in the U.S. is $18 billion annually and increasing. Fosteum PLUS offers opportunities for lowering the cost of osteoporosis in multiple ways:
    • Monthly Product Cost: Fosteum PLUS is on average 40% less expensive than leading branded prescription products for osteoporosis.
    • Total Cost of Care: Fosteum PLUS's low incidence of side effects may lead to significant savings and minimize otherwise costly drugs and/or hospitalizations associated with serious adverse events.
    • Increase in Bone Density: Fosteum PLUS has been proven to increase bone density over time and increased BMD has been linked to reduced fracture in the literature.
  • In clinical studies, 77.4% of patients osteoporotic at baseline were only osteopenic at 36 months based on T-score.
  • In clinical studies, 3.2% of patients osteoporotic at baseline were normal at 36 months based on T-score.

References

  • Morabito, et al. 2002. Effects of Genistein and Hormone-Replacement Therapy on Bone Loss in Early Postmenopausal Women: A Randomized Double-Blind Placebo-Controlled Study. J Bone & Mineral Research 17(10): 1904-1912.
  • Burnett, et al. Fosteum PLUS™: A New Therapeutic for the Clinical Dietary Management of Osteopenia and Osteoporosis with Utility for Menopausal Symptom Management. 7th International Symposium on Osteoporosis April 2007, Washington, DC.
  • Marini, et al. 2007. Effects of the Phytoestrogen Genistein on Bone Metabolism in Osteopenic Postmenopausal Women. A Randomized Trial. Ann Int Med. 19 June, 146 (12):839-848.
  • D'Anna, et al. 2007. Effects of the Phytoestrogen Genistein on Hot Flushes, Endometrium, and Vaginal Epithelium in Postmenopausal Women: A 1-Year Randomized, Double-blind, Placebo-controlled Study. Menopause 14(4):1-8.

U.S. Patent Nos. 5,935,996 and 5,516,925. Patents pending.

U.S. Patent No. 5,516,925 and Chelazome® are under license from Albion Laboratories, Inc, Clearfield, UT.

  • 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.