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

December 29, 2014 updated by: Bayer

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
Drug: Menostar (Estradiol, BAY86-5435)
Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
ACTIVE_COMPARATOR: Arm 2
Drug: Raloxifene
Raloxifene tbl. (60 mg/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage change in Bone Mineral Density at the lumbar spine
Time Frame: after 3 years
after 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage change in Bone Mineral Density of the hip
Time Frame: after 3 years
after 3 years
Percentage change in biochemical markers of bone turnover
Time Frame: after 6 months
after 6 months
Proportion of patients with hot flushes
Time Frame: after 3 year
after 3 year
Change in Women's Health Questionnaire
Time Frame: after 2 years
after 2 years
Proportion of patients with an abnormal endometrial biopsy
Time Frame: after 3 years
after 3 years
Pharmacogenetic analysis
Time Frame: after 2 years
after 2 years
Digital breast density analysis
Time Frame: after 2 years
after 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

March 31, 2006

First Submitted That Met QC Criteria

March 31, 2006

First Posted (ESTIMATE)

April 4, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91213
  • 306871

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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