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Friday, May 27, 2011

Revolutionary Nutraceutical Addresses an Unfilled Gap in Postmenopausal Bone Health

Ostera™: Revolutionary Nutraceutical Addresses an Unfilled Gap in Postmenopausal Bone Health

San Clemente, CA (March 9, 2009) — Metagenics, Inc. said today that it has launched a new nutraceutical called Ostera. This unique nutritional supplement supports the special needs of postmenopausal women, whose bone health may be affected by declining estrogen levels.*

Ostera is formulated to target bone remodeling, the normal lifelong process whereby old or damaged bone tissue is replaced by new bone tissue.

Conventional approaches to postmenopausal bone health may have adverse affects or not be well-tolerated. By contrast, Ostera is a gentle, all-natural formula without reported serious adverse effects.

Ostera is intended to complement natural bone mineralization support products, such as calcium and other minerals.* Its active ingredients are:
· Extracts from berberine and rho iso-alpha acids from hops — key botanical compounds shown to beneficially influence key markers of bone remodeling. In postmenopausal women, a decline in estrogen levels can contribute to changes in bone remodeling, where the rate of bone breakdown outpaces the rate of new bone formation.*
· Vitamin K – necessary for the metabolism of bone proteins crucial to bone integrity.*
· Vitamin D – associated with healthy bone formation and bone mineralization.*

Ostera was developed using Metagenics’ proprietary nutraceutical development model called the ExpresSyn® process. This exclusive model combines cellular research, safety evaluations, human ex vivo research, and clinical research. Through the ExpresSyn Process, Metagenics researchers have discovered a new generation of natural ingredients, such as acacia and hops, which function at the cellular level as selective kinase response modulators (SKRMs).*

Clinical research included a randomized, single-blinded, placebo-controlled study in which 77 postmenopausal women with low estrogen were placed on a lifestyle change program that included a Mediterranean-style, low-glycemic-load diet and 150 minutes of moderate exercise per week. The participants in the “Ostera arm” received the supplement twice daily for twelve weeks following a two-week run-in phase. The participants in the “control arm” received a placebo.

According to Joseph J. Lamb, MD, Metagenics Director of Intramural Clinical Research, “The Ostera arm reported no serious adverse affects and showed greater improvement in key biomarkers of bone remodeling.”* These biomarkers included:
· Osteocalcin (OC), an indicator of the rate of bone remodeling. A lower level of serum OC, moving towards reference range, is associated with a slower rate of bone breakdown in postmenopausal women. The Ostera arm displayed a statistically significant reduction in serum OC, while the control arm displayed an increase.*
· Insulin-like growth factor-1 (IGF-1), a recognized marker of bone formation and important in the maintenance of a healthy skeleton. IGF-1 declines after menopause. Both arms displayed a statistically significant increase in serum IGF-1; however the Ostera arm showed a greater average increase.*
· Vitamin D, which influences bone formation and is critical for calcium absorption to facilitate mineralization. The Ostera arm displayed a statistically significant increase in vitamin D status. The control arm displayed a decrease.*
· OC/Urinary N-telopeptide of type 1 procollagen (NTx), a marker of bone resorption. Ostera arm participants with high baseline NTx levels displayed a statistically significant reduction in serum OC. Control arm participants with high baseline NTx levels displayed an increase in serum OC.*

“Early on, we identified a need for a clinically tested, all-natural formula to support healthy bone remodeling,” said Lamb. “We believe Ostera fills that gap, thereby providing a further degree of support to postmenopausal women for whom bone mineralization support products, such as calcium and other minerals, may not be enough.” As with all Metagenics nutritional formulas, Ostera is only available through licensed health care practitioners.

Individuals interested obtaining Ostera should contact their health care professionals.

About Metagenics, Inc. Metagenics, headquartered in San Clemente, CA, is a global life sciences company focused on reversing chronic illness and improving health. Founded in 1983, the company serves tens of thousands of health care professionals and more than a million patients throughout the world and holds more than 40 propriety formula patents for use in nutraceucials, medical foods, and pharmaceuticals. Today, Metagenics continues its leadership role by successfully merging the disciplines of nutritional genomics, functional medicine, and therapeutic lifestyle change programs to find solutions to society’s most pressing health concerns.

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. ####

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