3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women
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.
2 other identifiers
interventional
500
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2004
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 31, 2006
CompletedFirst Posted
Study publicly available on registry
April 4, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedDecember 30, 2014
December 1, 2014
March 31, 2006
December 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage change in Bone Mineral Density at the lumbar spine
after 3 years
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORInterventions
Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
Eligibility Criteria
You may qualify if:
- Last (regular) menstrual period more than 5 years ago
- Relative good state of health
- Intact, normal uterus
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2006
First Posted
April 4, 2006
Study Start
February 1, 2004
Study Completion
June 1, 2007
Last Updated
December 30, 2014
Record last verified: 2014-12