Trial Condition(s):
Osteopenia
3-year study of Menostar versus Evista to prevent osteoporosis in post-menopausal women
Bayer Identifier:
91213
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations |
|---|
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Percentage change in Bone Mineral Density at the lumbar spineTimeframe: after 3 years
Secondary Outcome
- Percentage change in Bone Mineral Density of the hipTimeframe: after 3 years
- Percentage change in biochemical markers of bone turnoverTimeframe: after 6 months
- Proportion of patients with hot flushesTimeframe: after 3 year
- Change in Women's Health QuestionnaireTimeframe: after 2 years
- Proportion of patients with an abnormal endometrial biopsyTimeframe: after 3 years
- Pharmacogenetic analysisTimeframe: after 2 years
- Digital breast density analysisTimeframe: after 2 years
Additional Information
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