The effect of Femarelle^® was assessed on human bone through dual-energy x-ray absorptiometry (DEXA) scan of the hip and the spine.

In a clinical study, healthy post-menopausal women (n=98) were randomly allocated, on a double-blind basis, to receive either the recommended dosage of Femarelle^® (2 capsules of 644 mg/day) or a low dose (344 mg/day), supplemented with calcium, for twelve months. A comprehensive health questionnaire, and physical, laboratory and pelvic sonogram were performed at the start of the trial and every 3 months thereafter. Bone mineral density (BMD) was assessed by DEXA of the lumbar spine and femoral neck (hip) at enrollment and after twelve months of treatment.

Results

Efficacy

Following twelve months of treatment, BMD in the Femarelle^® group was increased by 3.6% in the lumbar spine and by 2.0% in the femoral neck.

Effect of Femarelle^® on BMD over 12 months

Safety

Neither group showed any change in endometrial thickness or in hormonal levels (FSH and E₂). There were no reported side effects.

Conclusion

Femarelle^® selectively affects estrogen receptors in the bone, increasing BMD without affecting the uterus. Since the hormonal blood profile was left unchanged this means that although the estrogen receptors were affected in target tissues, the body does not perceive Femarelle^® as estrogen.

Publication

Menopause 2003; 10(6):522-525: "Tofupill/Femarelle (DT56a) - a New Phyto-Selective Estrogen Receptor Modulator-like Substance for the Treatment of Postmenopausal Bone Loss”; I. Yoles et al.