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During menopause, estrogen levels drop rapidly and the activity of osteoblasts (bone formation cells) is decreased, so that the rate of osteoclasts (bone building cells) is less than bone resorption (bone, breakdown). This imbalance leads to loss of bone resulting in osteoporosis and an increased risk of fracture. When not managed, osteoporosis can result in serious consequences, such as hip and other bone fractures.
Signs and symptoms of menopause:
Fosteum Plus is a specially-formulated prescription medical food product consisting of a proprietary blend of calcium, phosphate, genistein (from a fermented, non-soy source) with citrated zinc bisglycinate (a special form of zinc that is absorbed more easily), trans-menaquinone-7 (MK-7), and cholecalciferol (Vitamin D3).
Fosteum Plus is for the clinical dietary management of the metabolic processes associated with osteopenia and osteoporosis. Fosteum Plus is indicated when a healthy diet and supplements such as calcium and Vitamin D are not enough. In fact, patients taking Fosteum Plus had an increase in bone mass density (BMD) by 9% over 3 years when compared to only Calcium and Vitamin D3 alone.
Have questions about Fosteum Plus? Contact one of our dedicated Patient Advocates at 1-888-546-2735 weekdays from 8:30 AM - 5:30 PM Arizona time.
Osteopenia is a classification for bone loss that is a precursor to osteoporosis. Someone with osteopenia has a lower bone density than normal, but not low enough for an osteoporosis diagnosis. Osteoporosis is a more serious condition that leaves bones fragile and prone to breaks. You may not know you are losing bone mass in the early stages of osteopenia because it doesn’t typically produce symptoms. However, if it progresses to osteoporosis you may develop back pain, a loss in height, and bones that easily break. Osteoporosis can limit physical activity and have a negative effect on overall health, happiness and quality of life.
Doctors diagnose the condition by measuring your T-score. Higher, positive numbers usually mean stronger bones. Negative numbers mean your bone density is lower than normal. A score between -1.0 and -2.5 indicates osteopenia or low bone mass. A score lower than -2.5 indicates osteoporosis.
Numerous clinical research studies demonstrate that early bone loss in women is linked to estrogen loss during menopause. The most bone loss occurs during the first two years of menopause.
Fosteum Plus is a prescription medical food, developed entirely from natural ingredients, and used to manage osteopenia and osteoporosis. In clinical trials, Fosteum Plus showed significant increases in bone density (and T-scores) at the spine and hip compared to calcium and vitamin D alone.
Fosteum Plus is a prescription medical food. The U.S. Food and Drug Administration (FDA) regulates medical foods in a separate category than drugs and supplements. Similar to drugs, medical foods help manage diseases and require physician supervision. Sound laboratory and clinical science must prove the effectiveness of a medical food. Dietary supplements are meant for healthy people and do not require a prescription. The term “food” speaks to the safety of these products because they must contain only ingredients that have been designated as GRAS (Generally Recognized as Safe), a strict food-safety standard set by the FDA.
Fosteum Plus contains key bone-building ingredients including genistein, zinc, calcium, phosphate, Vitamin K2, and Vitamin D in a single capsule. It also contains dicalcium malate, pentacalcium hydroxide triphosphate, citrated zinc bisglycinate, trans-menaquinone-7, cholecalciferol, micro-crystaline cellulose, magnesium stearate, silicon dioxide, and sodium copper chlorophyllin in a gelatin capsule with titanium dioxide as coloring.
Fosteum Plus does not contain fructose, glucose, sucrose, lactose, gluten, maltodextrin, tree nuts, peanuts, flavors or products of animal or seafood origin. It is suitable for vegans if you open the capsule and sprinkle what is inside over soft food, such as applesauce.
Fosteum Plus works on two levels. It is made of ingredients that build quality bone and the mechanisms needed to promote bone turnover and restore the process to its normal balance. It slows down the cells that break down bone and stimulates the production of cells and their activities that build bone.
In clinical trials, Fosteum Plus demonstrated a significant reduction in hot flashes over time. At 12 months, the frequency of hot flashes dropped by 57%, and the severity of hot flashes fell by 38%. In the same clinical trial, among women who experienced at least five hot flashes per day, 74% experienced improvement in the Fosteum Plus group versus none in the group taking calcium plus vitamin D alone. After two years, the hot flash number was about the same, but severity dropped by approximately another 30%.
The most common side effect of Fosteum Plus is minor nausea or upset stomach. If this happens to you, take Fosteum Plus with food because it may reduce the chance of side effects. In clinical trials, women who took Fosteum Plus and those who took a placebo (calcium and vitamin D) had the same types of side effects.
Women at risk for bone loss can take Fosteum Plus during menopause, when estrogen is decreasing, and post menopause, after periods have stopped for a year and ovaries no longer excrete estrogen. Women who have had surgery to remove their ovaries may also take Fosteum Plus. It is an option for women who can’t take or tolerate other bone loss therapies.
Do not take Fosteum Plus if you are allergic to any of its ingredients. Fosteum Plus is not intended for pregnant or nursing women, or women who are still producing estrogen and are of childbearing age.
Take one capsule two times a day approximately 12 hours apart. Fosteum Plus can be taken with or without food.
If you miss a dose, take it when you remember. If it is almost time for your next dose, wait and take the next dose on schedule.
Fosteum Plus is dispensed by prescription. The FDA regulates it as a medical food product, which must be used under physician supervision according to federal laws.
Primus Care Direct is a hassle-free, mail-order pharmacy service where patients can get their Fosteum Plus prescription for $49 for a 30-day supply or $117 for a 90-day supply ($39 per month), Medicare patients included. This is the lowest possible price available and includes free home delivery. If you have insurance, you may pay even less.
In addition to patient savings and convenience, Primus Care Direct saves time for healthcare practitioners by helping to increase fill rates and eliminating call-backs for prior authorizations.
Fosteum Plus is also available at retail pharmacies, but Primus Care Direct guarantees patients will pay the lowest possible price on their prescription.
Without affordable access to Fosteum Plus, and other prescription medical foods, patients will suffer. This is why Primus Pharmaceuticals (makers of Fosteum Plus) started an advocacy movement to help patients, families, caregivers, healthcare providers and others have a voice to take control of their health with better access to safer medicines.
Increasingly, Medicare, Medicaid, Tricare and commercial health plans will only cover expensive synthetic drugs that merely treat symptoms and can cause serious adverse events.
It’s time to create real healthcare reform and improve the quality of life for women who are experiencing the effects of menopause.