Company:

Primus

Genistein (as aglycone) 27mg, citrated zinc (as bisglycinate) 20mg, cholecalciferol (Vit.D₃) 200IU; caps; lactose-, gluten-free; contains soy.

Dietary management of osteopenia and osteoporosis.

Fosteum is a specially formulated blend of high purity genistein aglycone from soy, citrated zinc bisglycinate and cholecalciferol (vitamin D₃). It acts by restoring and maintaining the balance of bone turnover toward normal levels in osteopenia and osteoporosis.

Genistein, a soy isoflavone produced from non-GMO soybeans, has shown to reduce osteoclast-mediated bone resorption and stimulate the bone forming activity of osteoblasts by: reversing the effects of estrogen loss by decreasing cytokine production; increasing transforming growth factor β levels thus decreasing receptor activator of nuclear factor kappa B ligand production; increasing osteoprotegerin (OPG) levels; and decreasing overall osteoclast activity. Genistein has also been shown to reverse early apoptosis of osteoblasts and increase insulin-like growth factor-1 (IGF-1) which increases the number of proto-osteoblasts developed from stem cells resulting in increased recruitment of precursor cells to form osteoblasts.

Zinc is an essential mineral co-factor required by enzymes involved in bone metabolism. It has been shown to work synergistically with genistein and cholecalciferol to improve the absorption of calcium and its deposition into the mineral matrix of bone. The citrated bisglycinate form of zinc has been shown to have improved absorption from the intestine compared to inorganic zinc salts.

Cholecalciferol, the active form of Vit.D₃, regulates calcium and phosphate absorption and excretion as well as bone formation and resorption. Vitamin D deficiency is associated with a negative calcium balance, increased parathyroid hormone levels, bone loss and increased risk of skeletal fracture.

Two clinical trials were conducted to assess the efficacy of Fosteum in post-menopausal women with osteopenia or osteoporosis. The first randomized, double-blind, placebo-controlled trial included 389 patients that were either given genistein (n=198) or placebo (n=191). All subjects received calcium (1,000 mg/day) and Vit.D₃ (800 IU/day) in two divided doses. Efficacy was determined by the mean percent change in bone mineral density (BMD) at the 12-month and 24-month mark. A 2.4% and a 5.1% increase in BMD were seen in the femoral neck at 12- and 24-months, respectively, versus a decrease in BMD of 2.2% and 5.3% in the placebo group. Similar results were seen in the lumbar spine BMD where a 2.9% and a 5.8% increase was seen in the genistein group at 12- and 24-months, respectively, versus a decrease in BMD of 3.6% and 6.3% in the placebo group.

In a third year extension of this trial, 138 patients continued on a blinded study that showed further increases in BMD at both the lumbar spine (8.8%) and femoral neck (8.0%). Overall, 85% of the patients in the genistein arm showed increased BMD.

In the second trial, 90 osteopenic or osteoporotic, post-menopausal women were divided into three groups of 30. Patients taking genistein were compared to those on placebo or hormone replacement therapy (HRT). Percentage changes in BMD for the genistein group (femoral neck 3.6%; ward’s triangle 4.0%; and lumbar spine 3.0%) were generally higher when compared to the HRT (femoral neck 2.4%; ward’s triangle 3.0%; and lumbar spine 3.8%) and placebo groups (femoral neck -0.7%; ward’s triangle -0.4%; and lumbar spine -1.6%).

1 cap twice daily; supplement with calcium and Vit.D₃ as needed.

Not recommended.

History of breast or reproductive organ cancer. Pregnancy. Nursing mothers.

Not for treatment of Vit.D deficiency. Women who have 1st degree female relative with history of breast or reproductive cancer. Women capable of becoming pregnant (use adequate contraception). Males: not recommended. Severe hepatic or renal impairment. Conditions associated with overproduction of calcitriol (eg, leukemia, lymphoma, sarcoidosis) or signs/symptoms of Vit.D toxicity; monitor urine and serum calcium. Long-term supplementation or high-doses of zinc-containing products: monitor zinc and copper levels. GI malabsorption; may need higher Vit.D₃ doses (monitor). Ensure adequate calcium and Vit.D₃ intake.

Concomitant HRT, SERMs: not recommended. Vit.D₃ absorption may be decreased by bile acid sequestrants, mineral oil, orlistat, olestra. Cimetidine, thiazides, anticonvulsants may increase Vit.D₃ catabolism.

Abdominal and epigastric pain, dyspepsia, vomiting, constipation.

Caps—60

2/15/08