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3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00310531
Recruitment Status : Completed
First Posted : April 4, 2006
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):

March 31, 2006
April 4, 2006
December 30, 2014
February 2004
Not Provided
Percentage change in Bone Mineral Density at the lumbar spine [ Time Frame: after 3 years ]
To evaluate the safety and efficacy of Magnevist® Injection enhanced MRA at two doses in comparison to non contrast MRA for the detection of structural abnormalities of the infrarenal aorta and peripheral arteries using X-ray angiography as the standard
Complete list of historical versions of study NCT00310531 on ClinicalTrials.gov Archive Site
  • 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 ]
To evaluate patient management, image quality and artifacts of Magnevist® Injection enhanced MRA in comparison to non contrast MRA using X-ray angiography as the standard of reference.
Not Provided
Not Provided
 
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Osteopenia
  • Drug: Menostar (Estradiol, BAY86-5435)
    Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
  • Drug: Raloxifene
    Raloxifene tbl. (60 mg/day)
  • Experimental: Arm 1
    Intervention: Drug: Menostar (Estradiol, BAY86-5435)
  • Active Comparator: Arm 2
    Intervention: Drug: Raloxifene
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
June 2007
Not Provided

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)
Sexes Eligible for Study: Female
55 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00310531
91213
306871
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP