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Tofupill/Femarelle (DT56a): a new phyto-selective estrogen receptor modulator-like substance for the treatment of postmenopausal bone loss

Yoles, Israel MD1; Yogev, Yariv MD2; Frenkel, Yair MD1; Nahum, Ravit MD2; Hirsch, Michael MD2; Kaplan, Boris MD2

doi: 10.1097/01.GME.0000064864.58809.77

Objective To evaluate the efficacy of Tofupill/Femarelle (DT56a), a novel phyto-selective estrogen receptor modulator (SERM), in preserving bone mineral density (BMD) in postmenopausal women.

Design The study sample consisted of 98 healthy, postmenopausal women who were randomly allocated, on a double-blind basis, to receive either 644 mg/d DT56a (study group) or 344 mg/d DT56a supplemented with calcium (low-dose group) for 12 months. Each participant was assessed with a comprehensive health questionnaire, a detailed physical, and laboratory and pelvic sonogram examinations at entry and every 3 months thereafter. BMD was assessed by dual-energy x-ray absorptiometry (Lunar) of the lumbar spine and femoral neck before the study began and after 12 months of treatment.

Results After 12 months of treatment, BMD had increased in the study group by 3.6% in the lumbar spine (P = 0.039) and by 2.0% in the femoral neck (NS). In the low-dose group, BMD had decreased in the lumbar spine by 0.6% (NS) and by 0.6% in the femoral neck (NS). Comparison of the change in bone density between the groups yielded a significant difference for the lumbar spine (P = 0.037). Neither group showed a change in endometrial thickness and sex hormone levels nor reported any side effects of treatment.

Conclusions Tofupill treatment in postmenopausal women increases BMD without unwanted estrogenic effect. Tofupill appears to be a promising phyto-SERM for the prevention of postmenopausal osteoporosis.

From the 1Department of Obstetrics and Gynecology, Sheba Medical Center, Tel Hashomer, Israel; 2Department of Obstetrics and Gynecology, Rabin Medical Center, Petah Tikva, Israael; and 1,2Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Received November 11, 2002; revised and accepted February 11, 2003.

Address correspondence to: Prof. Boris Kaplan, MD, Department of Obstetrics and Gynecology, Rabin Medical Center, Petah Tikva 49100, Israel; e-mail:

©2003The North American Menopause Society