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.”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Menostar (Estradiol, BAY86-5435)
  • Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
• Drug: Raloxifene
  • Raloxifene tbl. (60 mg/day)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Active Comparator: Arm 2

Primary Measures

• Percentage change in Bone Mineral Density at the lumbar spine
  • Time Frame: after 3 years
    

Secondary Measures

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

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)

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00310531

Study ID Number: 91213

ClinicalTrials.gov Identifier: NCT00310531

Health Authority: Denmark: Danish Medicines Agency

Click here and search for drug information provided by the FDA

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product

Click here to find results for studies related to marketed products