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

Abstract

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.

• Authors: Israel Yoles, Yariv Yogev, Yair Frenkel, Ravit Nahum, Michael Hirsch, Boris Kaplan
• Journal: Menopause (New York, N.Y.) (Menopause) 2003 Nov-Dec Vol. 10 Issue 6 Pg. 522-5 ISSN: 1072-3714 [Print] United States
• PMID: 14627860 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• DT56a
• Plant Extracts
• Selective Estrogen Receptor Modulators

Topics

• Bone Density (drug effects)
• Double-Blind Method
• Female
• Follow-Up Studies
• Humans
• Middle Aged
• Osteoporosis, Postmenopausal (drug therapy)
• Plant Extracts (therapeutic use)
• Prospective Studies
• Selective Estrogen Receptor Modulators (therapeutic use)