New Proof of Genistein’s Efficacy and Safety for Osteopenia and Osteoporosis Published in Annals of Internal Medicine

SCOTTSDALE, Ariz.--(BUSINESS WIRE)--Annals of Internal Medicine has published the results of a two-year clinical study on the impact of genistein on bone loss. The paper, “Effects of the Phytoestrogen Genistein on Bone Metabolism in Osteopenic Postmenopausal Women-A Randomized Trial,” appears in the current issue (June 19, 2007) and details the safety and efficacy of genistein for the dietary management of osteopenia and osteoporosis. The paper reports a significant gain in bone density among patients taking genistein at both 12 and 24 months over both baseline and placebo.

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 supplement 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.”