Frequently Asked Questions

What are the most common side effects of Fosteum?

The most common side effects of Fosteum are mild to moderate GI symptoms, like nausea, dyspepsia and constipation. If a patient has these symptoms, they may be alleviated by taking Fosteum with food.

How should my patients take Fosteum?

Fosteum should be taken twice a day, with a calcium and vitamin D supplement to ensure adequate intake of these crucial nutrients for bone. Fosteum has no postural limitations and may be taken with or without food and with any beverage. This convenient regimen will likely lead to high levels of compliance among your patients, and serve as a reminder to take their calcium and D supplements daily in divided doses.

Fosteum contains a phytoestrogen. Does it have any adverse effects on breast or reproductive tissues?

In clinical trials possible estrogenic effects of genistein were actively investigated. Clinical trials included the following safety endpoints:

  1. Digital mammograms;
  2. Uterine ultrasounds;
  3. Endometrial biopsies in patients with endometrial thickness >8 mm or vaginal bleeding;
  4. Vaginal cytology.

Importantly, there were no differences between the genistein and placebo groups, nor change from baseline over periods as long as three years in these measurements. These data suggest that Fosteum does not produce estrogenic effects on breast or reproductive tissues.

Does Fosteum have any hepatic or renal effects?

In clinical trials, there were no changes in laboratory markers of kidney or liver function among healthy postmenopausal women over a three year period.

Have the effects of genistein on cardiovascular function been investigated?

The genistein in Fosteum was shown to increase plasma nitric oxide breakdown products, reduce endothelin-1 levels and improve endothelial-dependent vasodilation in postmenopausal women. In a two year study of 389 postmenopausal women, administration of the genistein in Fosteum was shown to significantly reduce plasma levels of the cardiovascular risk markers fibrinogen, F2-isoprostanes, sICAM-1 and sVCAM-1 after 24 months compared to placebo. Other markers of CV safety such as cholesterol, homocysteine and CRP were unchanged. Therefore, based on results from laboratory tests of cardiovascular risk, Fosteum appears safe for the heart and vasculature.

Can I obtain Fosteum samples for my practice?

You can fill in the Request Samples form on this website or you can call 480-483-1410 to have a sample request form faxed to you.

Does Fosteum have any effect on menopausal symptoms?

In a 12-month, prospective, randomized, double-blind, placebo-controlled study involving 247 symptomatic post-menopausal women, the genistein in Fosteum was shown to reduce the number of hot flashes in 74% of the women reporting 5 or more hot flashes per day at baseline by an average of approximately 50%. The severity of hot flashes was also reduced by 37.5% over the 12 month period. A significant reduction in hot flash number and severity was observed at the 1, 3, 6, and 12 month follow-up visits, with progressive improvement observed throughout the treatment period. Anecdotally, women have reported reductions in vasomotor symptoms within the first week of taking Fosteum.

What is the managed care status of Fosteum?

Fosteum is covered by many managed care organization, but coverage varies by plan. Even in cases in which Fosteum is not covered by a patient’s plan the price of Fosteum falls within the standard range of third tier co-pays and is approximately 40% less expensive than drug treatments for bone loss. Primus also offers a point-of-sale discount card that a patient may use for savings on Fosteum and many other prescription products. These cards can be requested on-line.

What is a medical food?

Medical foods are a special category, established by federal law and regulated by the FDA. Medical foods are designed for the dietary management of a specific disease state and must meet a specific series of requirements including:

  • GRAS (Generally Recognized As Safe) status for all ingredients – this rigorous safety standard applies to all food ingredients;
  • The nutrients in medical foods must meet the distinctive requirements of a specific disease state;
  • Medical foods must be administered orally;
  • Medical foods must be administered under a physician’s supervision (Rx required);
  • The nutrients provided must not be available by a simple change of diet.

Fosteum is the first medical food product indicated for the dietary management of the metabolic processes of osteopenia and osteoporosis. Extensive published clinical trial evidence demonstrates that Fosteum effectively rebalances bone metabolism in favor of bone formation, leading to increases in BMD over time.

Last modified on 08-13-2007