Back to results3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women
Primary Purpose
Osteopenia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Menostar (Estradiol, BAY86-5435)
Raloxifene
Sponsored by
About this trial
This is an interventional prevention trial for Osteopenia
Eligibility 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Percentage change in Bone Mineral Density at the lumbar spine
Secondary Outcome Measures
Percentage change in Bone Mineral Density of the hip
Percentage 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00310531
Brief Title
3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women
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 Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Menostar (Estradiol, BAY86-5435)
Intervention Description
Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
Intervention Type
Drug
Intervention Name(s)
Raloxifene
Intervention Description
Raloxifene tbl. (60 mg/day)
Primary Outcome Measure Information:
Title
Percentage change in Bone Mineral Density at the lumbar spine
Time Frame
after 3 years
Secondary Outcome Measure Information:
Title
Percentage change in Bone Mineral Density of the hip
Time Frame
after 3 years
Title
Percentage change in biochemical markers of bone turnover
Time Frame
after 6 months
Title
Proportion of patients with hot flushes
Time Frame
after 3 year
Title
Change in Women's Health Questionnaire
Time Frame
after 2 years
Title
Proportion of patients with an abnormal endometrial biopsy
Time Frame
after 3 years
Title
Pharmacogenetic analysis
Time Frame
after 2 years
Title
Digital breast density analysis
Time Frame
after 2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women
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