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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Osteopenia

Intervention / Treatment
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* Drug: Menostar (Estradiol, BAY86-5435)
* Drug: Raloxifene


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Menostar (Estradiol, BAY86-5435)<br>* Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)<br>|
| Active Comparator: Arm 2<br> | Drug: Raloxifene<br>* Raloxifene tbl. (60 mg/day)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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