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Related Experiment Videos

Osteoporosis prevention clinical study program

P Delmas1, A Gimona

  • 1Service de Rhumatologie et de Pathologie Osseuse, Hôpital E. Herriot, Lyon, France.

European Journal of Obstetrics, Gynecology, and Reproductive Biology
|April 1, 1996
PubMed
Summary

This study investigated Menorest doses for preventing postmenopausal bone loss. Results are pending, but the methodology ensures precise bone mineral density measurements for accurate efficacy assessment.

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Area of Science:

  • Endocrinology
  • Bone Metabolism
  • Pharmacology

Background:

  • Oestrogens are believed effective for postmenopausal osteoporosis.
  • Minimal effective oestradiol dose and its relation to bone efficacy require clarification.

Purpose of the Study:

  • Evaluate Menorest efficacy in preventing bone loss in early postmenopausal women.
  • Determine optimal oestradiol doses and regimens for Menorest therapy.
  • Clarify the relationship between oestradiol levels and bone turnover/mass.

Main Methods:

  • Phase II/III, double-blind, placebo-controlled, dose-ranging studies (201 & 305) over 2 years.
  • Two regimens: cyclic sequential and continuous sequential transdermal oestradiol.
  • Doses ranging from 25-100 mcg/day, with dydrogesterone co-administration.

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  • Primary endpoint: change in lumbar spine bone mineral density (BMD) via DXA; secondary: bone turnover markers and safety.

    • Main Results:

    • Data from 146 patients (demographics) and 370 (baseline DXA) analyzed.
    • Mean age 53.4 years, 38.3 months post-menopause; mild vasomotor symptoms.
    • Baseline lumbar spine BMD T-score: -1.17; other sites within normal range or above mean (whole body).

    Conclusions:

    • Methodology utilizes advanced DXA with quality control for precise BMD assessment.
    • Improved in-vivo BMD precision enhances the reliability of efficacy evaluations.