3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women
Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteopenia
Intervention: Menostar (Estradiol, BAY86-5435) (Drug); Raloxifene (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Summary
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.
Clinical Details
Official 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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Percentage change in Bone Mineral Density at the lumbar spine
Secondary outcome: Percentage change in Bone Mineral Density of the hipPercentage change in biochemical markers of bone turnover Proportion of patients with hot flushes Change in Women's Health Questionnaire Proportion of patients with an abnormal endometrial biopsy Pharmacogenetic analysis Digital breast density analysis
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.
Eligibility
Minimum age: 55 Years.
Maximum age: 80 Years.
Gender(s): Female.
Criteria:
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)
Locations and Contacts
Additional Information
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Starting date: February 2004
Last updated: December 29, 2014
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