Clinical Study Finds Dietary Supplement Femarelle(TM) Increases Bone Mineral Density in Postmenopausal Women

Findings of Published Study Offer Clinically Proven Option for Women Seeking Alternative for Improving Bone Health

YAVNE, Israel, June 1 /PRNewswire/ -- A recently published clinical study in the Journal of the North American Menopause Society: Menopause (Vol. 10, No. 6, 2003), finds that the dietary supplement Femarelle(TM) (DT56a), described as a "new phyto-selective estrogen receptor modulator (SERM)," can increase bone mineral density in postmenopausal women, without affecting more sensitive tissues, such as the breast and uterus.

"Preserving bone mineral density is a challenge that post-menopausal women have been faced with for years," says Israel Yoles, MD, Department of Obstetrics and Gynecology, Sheba Medical Center, Tel Hashomer, Israel, and an author of the article. "With the increased odds of osteoporotic fractures due to the rise in life expectancy, along with the disadvantages and side effects of existing methods of slowing age-related bone resorption and enhancing bone formulation, it is extremely exciting to be able to offer postmenopausal women a safe, clinically proven alternative that not only increases bone mineral density, but also reduces menopausal symptoms, such as hot flashes and sleep disturbances(1)."

Dr. Yoles, says that following the natural decline in estrogen levels, all women go through a process of increased loss of bone mineral density, the measurement of the mineral content of bones that determines the severity of osteoporosis. Calcium supplements, which are recommended to most women at age 50, will help maintain the level of calcium necessary for healthy bones, but will not build bone density, he adds.

However, Femarelle(TM), which is sold by Se-cure Pharmaceuticals Ltd. in more than 12 other countries since 1999 (also available under the name Tofupill) and now available in the U.S., has been shown through this double-blind, randomized 12-month study to actually increase bone mineral density, offering postmenopausal women a clinically-proven alternative for improving bone health.

"According to the study, after just 12 months of using Femarelle(TM), bone mineral density had increased in the study group by 3.6% in the lumbar spine and 2% in the femoral neck," Dr. Yoles, a medical advisor to Se-cure Pharmaceuticals, explains.

According to the authors of the article, "Tofupill/Femarelle (DT56a): a new phyto-selective estrogen receptor modulator-like substance for the treatment of postmenopausal bone loss", Femarelle(TM), consisting of 322 mg of DT56a* and 108 mg of grounded flaxseed, proved to be an effective treatment of postmenopausal bone loss. Previously published(1), a 12-month-long clinical trial, showed that Femarelle(TM) also alleviates menopausal symptoms, such as hot flushes, headaches, joint and muscle discomfort and palpitations in about 75% of participants, without changes in the breast tissue, endometrial thickness or in the hormonal blood profile (FSH and E2 levels).

A study of efficacy and safety of DT56a/Femarelle(TM) for menopausal symptoms -- the fourth peer-reviewed report on this phyto-SERM published in 12 months -- has been accepted for publication in the Journal of Clinical & Experimental Obstetrics & Gynecology and will be published in the coming months.

Se-cure Pharmaceuticals Ltd., which manufactures and distributes Femarelle(TM)/Tofupill in the U.S. and abroad, is a research-driven pharmaceutical company headquartered in Israel, whose principal mission is the discovery, development and manufacturing of products that offer safe and innovative solutions to health needs. The company aligns its product development with basic research, including chemical and biochemical research, as well as pre-clinical and clinical studies. The company's vision centers on the development of therapeutic solutions with an emphasis on safety of use and the prevention of side effects following long-term use.

1. Obstetrics & Gynecology, 2003:101 (4S):98-99: "Selective Estrogen Receptor Modulation by Tofupill, a Unique Phyto-SERM for Menopausal Treatment"; Yoles I, Chayen B.A.

* DT56a (the active substance in Femarelle(TM)) is the generic name of a compound isolated from tofu. A unique enzymatic process of isolation is employed to ensure that the whole isoflavone family, the lignans and the coumestans, remain in their naturally intact form with a high bio-availability to the body. As such, the product preserves the beneficial effect of the soybean. Femarelle(TM) is a standardized product that provides women with consistent and reliable relief of menopausal symptoms and continuous improvement in bone health.

Evaluating the efficacy of phyto-SERM DT56a in elevating bone mineral
density (BMD) in postmenopausal women.
* Study sample -- 98 healthy, postmenopausal women randomly allocated on
double-blind basis to receive either 644 mg/d DT56a (study group) or
344 mg/d DT56a supplemented with calcium (control group)
* 12-month period
* BMD assessed by dual-energy x-ray absorptiometry (DEXA) of the lumbar
spine and femoral neck before study began and after 12 months treatment
* Endometrial thickness and sex hormone levels were assessed every three
months during the study
* Results: BMD increased in study group by 3. 6% in lumbar spine and by
2.0% in femoral neck; in control group, BMD decreased by 0.6% in both
the lumbar spine and femoral neck. For lumbar spine, the change in
bone density between the groups was significant.
* Neither group showed a change in endometrial thickness and sex hormone
levels nor reported any side effects of treatment

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