Frequently Asked Questions (FAQs): Fosteum (fos-tee-um)

What is Fosteum?

Fosteum is a specially formulated prescription medical food, developed from natural ingredients, that is used for the clinical dietary management of osteopenia and osteoporosis. Fosteum is indicated when a good diet and supplements like calcium plus vitamin D are not enough, but you are not ready for drugs with their potential for side effects. Learn more about Fosteum

Is Fosteum safe?

All the ingredients in Fosteum are GRAS (Generally Accepted As Safe). GRAS is a strict FDA designation that applies to all food ingredients and indicates that the ingredient is safe for its intended use. All medical foods must contain GRAS ingredients. In addition, Fosteum has been tested for safety in clinical trials. In three studies over one, two and three years, safety was determined by tracking vaginal bleeding and by measuring uterine endometrial thickness (vaginal bleeding and thickening indicate possible uterine cancer) and by regular measurement of breast density (increased density indicates possible breast cancer). No changes were seen in breast or uterus measurements in either the genistein group or the placebo group. Learn more about medical foods.

What are osteopenia and osteoporosis?

Osteopenia and osteoporosis are grades of the same condition indicating degrees of bone loss. Learn more about osteoporosis and osteopenia

What is a T-score and how is it measured?

A T-score is a measure of how dense is your bone. Higher numbers usually mean stronger bone. The T-score is determined by comparing your bone to the bone of a large group of healthy 30 year olds. The difference between your result and the young average result is a T-score. If your bone is the same as the young average the result would be 0. If your result is lower than the young average, your T-score would be a minus number. A score between -1.0 and -2.5 indicates osteopenia. A score lower than -2.5 indicates osteoporosis.

How do I know if I have osteopenia or osteoporosis?

The best way to know is to KNOW YOUR T-SCORE. That means you should have a DXA and get your doctor to tell you what your score is at spine and hip. If your T-score at any site is -1.0 to ‑2.5, you have osteopenia (your bone mass is lower than average). If your T-score is worse than ‑2.5, you have osteoporosis.

If you do not know your T-score, at first, you would not know if you are losing bone because osteopenia and osteoporosis have no symptoms in the beginning. That’s why osteoporosis is called “The Silent Disease”. There is no pain or feeling of discomfort when osteoporosis begins. Later, after a lot of bone is lost,

  • You may break a bone, even from simple everyday movements.
  • Broken bones may cause you to require assistance with routine living. The majority of people over 50 who break a hip lose their independence and 20% die in the year following the break.
  • You may ‘shrink’ (get shorter) because of broken bones in your spine.
  • You may get a ‘dowager’s hump’, a curve to your spine caused by broken bones in your spine.
  • You may develop severe back pain that keeps you from doing things you want to do.

If I have a lot of risk factors for osteoporosis, can I take Fosteum?

If you and your doctor agree that early intervention is appropriate, you certainly can take Fosteum.

Talk to your doctor about Fosteum

What can I do to reduce my risk of osteopenia and osteoporosis?

You can change a lot of things that affect your bone health, like:

  • If you smoke, stop.
  • Exercise. When you do weight bearing exercise it stimulates your bones to become stronger. This may be walking, stair climbing, dancing or lifting weights. The weights do not have to be heavy. Lifting even a one pound weight will help to increase bone strength.
  • Do not drink more than one or two alcoholic drinks each day.
  • Make sure you get enough calcium and vitamin D.

Learn more about lifestyle changes

How does Fosteum work?

Fosteum decreases the activity of cells that break down bone and stimulates the cells that build up bone. This restores a more normal balance of bone breakdown and formation (also called bone turnover) and results in increased bone mass. Increased bone mass may lead to a reduced risk of fracture over time. You won’t feel a change, but your BMD may increase over time. Learn more about how Fosteum works

Who should take Fosteum?

Anyone at risk for bone loss may take Fosteum.
Women approaching menopause (the change), women in menopause and women after menopause may take Fosteum.
Women who have had surgery to remove their ovaries may take Fosteum. Read more about taking Fosteum

Who should not take Fosteum?

Do not take Fosteum:

  • If you are allergic to any ingredient in Fosteum. (See What are the ingredients in Fosteum?)
  • If you’re pregnant or nursing (because it has not been tested in pregnant or nursing women.)
  • If you are under 18 years of age (because it has not been tested in pediatric patients.)
  • If you are taking hormone therapy or a SERM (Selective Estrogen Receptor Modulator, such as Evista®) for osteoporosis (because it has not been tested in combination with these products).
  • If you have or have had cancer of the breast or reproductive organs.

Talk to your doctor about Fosteum

How should I take Fosteum?

  • Take Fosteum with or without food. Take it with any beverage you like, even grapefruit juice or coffee.
  • You do not have to stand or sit after taking Fosteum. You may take Fosteum and lie down immediately if you wish.
  • Decide on convenient times to take Fosteum. Take one capsule approximately every 12 hours; for example, when you get up in the morning and after your evening meal, or any other combination that works for your schedule and makes it easy to remember. Learn more about taking Fosteum

What are the possible side effects of Fosteum?

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.

Does Fosteum have any effect on hot flashes?

In the clinical study all women were asked to keep a journal describing any symptoms that they may have. This should include GI effects, hot flashes, etc. An important point is that the women were never told that hot flashes were being studied. They were only told that bone was being studied. The investigators examined the journals and then followed the women who reported hot flashes in their journals. This is important because hot flash studies are notorious for high placebo effect – that is, a large number of the patients taking placebo report reductions in hot flashes. Since these patients were never told that hot flashes were being studied, placebo effect was minimal. This says that the genistein in Fosteum was responsible for the reductions.

Read more about the clinical study.

Graph: Number of Hot Flashes Graph: Severity of Hot Flashes

In clinical trials, the women who suffered from hot flashes and took Fosteum had fewer hot flashes and the hot flashes they did have were not as strong. This improved hot-flash effect of Fosteum became better the longer they took Fosteum. Talk to your doctor about Fosteum

What if I miss my dose of Fosteum?

If you miss a dose you may take it when you remember. If it is very close to the time for your next dose, wait and take the next dose on schedule. Read more about taking Fosteum

What are the ingredients in Fosteum?

Fosteum contains genistein (isolated from soy), zinc chelazome*, and cholecalciferol (vitamin D3). Dicalcium malate, magnesium oxide, microcrystalline cellulose, magnesium stearate and silicon dioxide are used as fillers and Vcap® (veggiecaps) as the capsule. FD&C Blue #2 is used for the printing on the capsule. Fosteum does not contain fructose, glucose, sucrose, lactose, gluten, maltodextrin, tree nuts, peanuts, flavors or products of animal or seafood origin. Fosteum is suitable for vegans. The soybeans used for the genistein in Fosteum are organic and not genetically modified (non-GMO).

What if I’m allergic to soy?

Since the genistein in Fosteum is isolated from soy you should discuss your allergy with your doctor. If you are allergic to any ingredient in Fosteum, you should not take Fosteum.

What if I have other questions about Fosteum?

If you need more information, ask your health care provider or pharmacist. They can give you information written for health care professionals. You may also review the other sections of this website.

General Information about Fosteum

Store Fosteum at room temperature between 59°F and 86°F (15°C and 30°C).

Keep out of the reach of children.

Last modified on 09-26-2007