check_circleStudy Completed

Osteopenia

Bayer Identifier:
91213
ClinicalTrials.gov Identifier:
NCT00310531
EudraCT Number:
Not Available
EU CT Number:
Not Available
3-year study of Menostar versus Evista to prevent osteoporosis in post-menopausal women

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.

Key Participants Requirements

Sex

Female

Age

55 - 80 Years
  • - Last (regular) menstrual period more than 5 years ago
    - Relative good state of health
    - Intact, normal uterus
  • - 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
500
Trial Dates
February 2004 - June 2007
Phase
Phase 3
Could I Receive a placebo
No
Products
Menostar (E2 transdermal, BAY86-5435)
Accepts Healthy Volunteer
No

Primary Outcome

  • Percentage change in Bone Mineral Density at the lumbar spine
    date_rangeTime Frame:
    after 3 years
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Percentage change in Bone Mineral Density of the hip
    date_rangeTime Frame:
    after 3 years
    enhanced_encryption
    Safety Issue:
    None
  • Percentage change in biochemical markers of bone turnover
    date_rangeTime Frame:
    after 6 months
    enhanced_encryption
    Safety Issue:
    None
  • Proportion of patients with hot flushes
    date_rangeTime Frame:
    after 3 year
    enhanced_encryption
    Safety Issue:
    None
  • Change in Women's Health Questionnaire
    date_rangeTime Frame:
    after 2 years
    enhanced_encryption
    Safety Issue:
    None
  • Proportion of patients with an abnormal endometrial biopsy
    date_rangeTime Frame:
    after 3 years
    enhanced_encryption
    Safety Issue:
    None
  • Pharmacogenetic analysis
    date_rangeTime Frame:
    after 2 years
    enhanced_encryption
    Safety Issue:
    None
  • Digital breast density analysis
    date_rangeTime Frame:
    after 2 years
    enhanced_encryption
    Safety Issue:
    None

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

Additional Information

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