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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
500
Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
Raloxifene tbl. (60 mg/day)
Percentage change in Bone Mineral Density at the lumbar spine
Time frame: after 3 years
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
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