Skip to main content
OpenTrials
Completed

NCT Number: NCT00310531

3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women

The aim of this trial is to investigate whether the Menostar patch is as safe and effective in the prevention of bone loss in postmenopausal women as raloxifen, a drug already registered for prevention and treatment of osteoporosis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteopenia Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

55 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Last (regular) menstrual period more than 5 years ago
  • Relative good state of health
  • Intact, normal uterus

Exclusion criteria

  • Bone and musculoskeletal diseases
  • Clinically significant vertebral fracture within the last 12 months
  • Pre-existing cardiovascular disease (e.g. uncontrolled high/low blood pressure, stroke, thromboembolic event etc)
  • Uncontrolled diabetes mellitus (or treated with insulin)
  • Uncontrolled thyroid disorders
  • Relevant renal disorder or significant liver dysfunction (including cholestasis)
  • History of alcohol or drug abuse
  • History of immobilization of more than 2 months in the last 6 months
  • Smoking of more than 10 cigarettes per day
  • Unexplained uterine bleeding
  • Known or suspected malignant or premalignant disease (e.g. cancer of breast or uterus, melanoma)

Treatment and study plan

Menostar (Estradiol, BAY86-5435)

Drug

Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)

Raloxifene

Drug

Raloxifene tbl. (60 mg/day)

Primary outcomes

  1. Percentage change in Bone Mineral Density at the lumbar spine

    Time frame: after 3 years

Secondary outcomes

  1. Percentage change in Bone Mineral Density of the hip

    Time frame: after 3 years

  2. Percentage change in biochemical markers of bone turnover

    Time frame: after 6 months

  3. Proportion of patients with hot flushes

    Time frame: after 3 year

  4. Change in Women's Health Questionnaire

    Time frame: after 2 years

  5. Proportion of patients with an abnormal endometrial biopsy

    Time frame: after 3 years

  6. Pharmacogenetic analysis

    Time frame: after 2 years

  7. Digital breast density analysis

    Time frame: after 2 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Double-Dummy, Randomized, Active- Controlled, 3-Year Study to Evaluate the Antiresorptive Efficacy, Safety and Tolerability of a Ultra-Low Dose Estradiol Transdermal Delivery System Releasing 0.014 mg / Day Versus Oral Raloxifene Hydrochloride 60 mg / Day - as a Therapy for the Prevention of Osteoporosis in Postmenopausal Female Osteopenic Patients.

Important dates

Study start
2004
Study completion
2007
First posted
Apr 4, 2006
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.