Fosteum Product Profile
“…when Calcium+D is not enough”
Prescription Required: #68040-603-16
Product Background
- Usage – For the clinical dietary management of the metabolic processes of osteopenia and osteoporosis.
- Ingredients – Genistein (isolated from soy), zinc chelazome (a glycine chelate) and cholecalciferol (vitamin D3), manufactured under cGMP standards.
- Administration – take one capsule every 12 hours, with calcium if taken, under a physician’s supervision. Safe to be taken with or without other foods or beverages.
- How Supplied – Fosteum is supplied in capsules containing 27 mg genistein, 20 mg zinc chelazome (zinc glycine chelate), 200 IU cholecalciferol (vitamin D3) and fillers in a Vcap®. Fosteum is dispensed by prescription only. FOSTEUM does not contain fructose, glucose, sucrose, lactose, gluten, maltodextrin, tree nuts, peanuts, flavors or products of animal origin. Fosteum 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 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 was shown to reduce the number and severity of hot flushes over a 12 month period.
Product Benefits
- Efficacy – Fosteum 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 inhibits the activity of osteoclasts thereby reducing bone resorption.
- At the same time, the genistein in Fosteum increases the recruitment, number and activity of osteoblasts thereby increasing bone formation.
- The zinc in Fosteum enhances the action of genestein and aids in bone mineralization.
- The cholecalciferol in Fosteum increases calcium absorption and bone mineralization.
- Safety – The ingredients in Fosteum 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 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 showed positive effects or no effect on markers of cardiovascular safety.
Menopausal Symptoms – Fosteum reduces the number and severity of hot flushes.
Clinical & Scientific Support – The beneficial actions of Fosteum 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 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 offers opportunities for lowering the cost of osteoporosis in multiple ways:
- Monthly Product Cost: Fosteum is on average 40% less expensive than leading branded prescription products for osteoporosis.
- Total Cost of Care: Fosteum’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 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™: 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.
Last modified on 07-27-2007