Key study findings include:
-- Over 85 percent of the women in the study taking genistein showed a gain in bone density.
-- Patients taking genistein in addition to calcium and vitamin D showed a gain in bone density of approximately 3 percent per year over baseline and 6 percent per year over those taking the placebo.
-- No adverse events were reported in the study. All participants were monitored for vasomotor symptoms, vaginal bleeding, breast tenderness, endometrial thickness, depression, irritability, insomnia, and gastrointestinal (GI) symptoms, as well as for changes in hematologic, renal and liver function tests. No changes were noted in any of these parameters except for mild GI symptoms.
Patients in the test group of the study used 54 mg/day of highly purified genistein isolated from soy along with calcium and vitamin D. Principle Investigator for the study, Francesco Squadrito, M.D., Professor of Pharmacology and Head of Clinical Pharmacology, School of Medicine, University of Messina, Italy, explains that there were some interesting aspects to the study: "The placebo in this study was not an inactive pill; instead it was the current standard of care for osteopenia - calcium plus vitamin D. Unlike other research in this area, this study was controlled for soy intake and additional supplem ent use, either of which may confound the results of a study."
The National Osteoporosis Foundation reports that osteoporosis currently afflicts more than 10 million Americans, while an additional 34 million have osteopenia. Osteopenia is the required precursor to osteoporosis. The lack of safe, efficient therapy for osteopenia beyond lifestyle changes with calcium and vitamin D leaves many patients and physicians with a lack of options.
Fosteum, the first prescription product developed to safely meet the nutritional requirements of patients with osteopenia and osteoporosis, is being introduced nationally by Primus Pharmaceuticals, Inc. Fosteum's genistein, which was evaluated in this clinical study, is highly concentrated and cannot be achieved simply through dietary change. According to Dr. Squadrito, "To obtain the amount of genistein found in two capsules of Fosteum, one would have to consume 26 pounds of soybeans or over two gallons of soy milk each day." Since no other product contains the same genistein as found in Fosteum, Dr. Squadrito urges caution in transferring the information in his paper to supplements purporting to contain genistein: "Supplements contain much lower concentrations of genistein and have other, sometimes unidentified, compounds in addition to genistein."
For more information on Fosteum, please visit www.fosteum.com.
About Primus Pharmaceuticals, Inc.
Primus is the first pharmaceutical company to focus on prescription metabolic products dedicated to improving patient quality of life without compromising safety. Primus develops branded prescription drugs and medical foods that are proven safe and effective in chronic or recurring diseases. The Company's needs-based process to develop first-line prescription products formulated to restore metabolic processes at the disease source (rather than masking symptoms) is novel and proprietary. Primus promotes to targeted physician specialists and extends its sale s reach and clinical capabilities through strategic partnerships. All products are protected by composition of matter patents and other intellectual property. Primus is privately held and based in Scottsdale, Ariz. For more information, visit www.primusrx.com.
Fosteum is a prescription medical food product for the clinical dietary management of the metabolic processes of osteopenia and osteoporosis.
Jodi Amendola, 480-664-8412, x11