NCT00310531
Completed
Phase 3
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.
ConditionsOsteopenia
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 500
- Primary Endpoint
- Percentage change in Bone Mineral Density at the lumbar spine
Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 55 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm 1
Experimental
Intervention: Menostar (Estradiol, BAY86-5435) (Drug)
Arm 2
Active Comparator
Intervention: Raloxifene (Drug)
Outcomes
Primary Outcomes
Percentage change in Bone Mineral Density at the lumbar spine
Time Frame: after 3 years
Secondary Outcomes
- Percentage change in biochemical markers of bone turnover(after 6 months)
- Proportion of patients with hot flushes(after 3 year)
- Percentage change in Bone Mineral Density of the hip(after 3 years)
- Proportion of patients with an abnormal endometrial biopsy(after 3 years)
- Digital breast density analysis(after 2 years)
- Change in Women's Health Questionnaire(after 2 years)
- Pharmacogenetic analysis(after 2 years)
Investigators
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