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

Menopause. Nov-Dec 2003;10(6):522-5. doi: 10.1097/01.GME.0000064864.58809.77.

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • 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*

Substances

  • DT56a
  • Plant Extracts
  • Selective Estrogen Receptor Modulators