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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. Identifier: NCT00310531
Recruitment Status : Completed
First Posted : April 4, 2006
Last Update Posted : December 30, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Osteopenia Drug: Menostar (Estradiol, BAY86-5435) Drug: Raloxifene Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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.
Study Start Date : February 2004
Actual Study Completion Date : June 2007

Arm Intervention/treatment
Experimental: Arm 1 Drug: Menostar (Estradiol, BAY86-5435)
Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)

Active Comparator: Arm 2 Drug: Raloxifene
Raloxifene tbl. (60 mg/day)

Primary Outcome Measures :
  1. Percentage change in Bone Mineral Density at the lumbar spine [ Time Frame: after 3 years ]

Secondary Outcome Measures :
  1. Percentage change in Bone Mineral Density of the hip [ Time Frame: after 3 years ]
  2. Percentage change in biochemical markers of bone turnover [ Time Frame: after 6 months ]
  3. Proportion of patients with hot flushes [ Time Frame: after 3 year ]
  4. Change in Women's Health Questionnaire [ Time Frame: after 2 years ]
  5. Proportion of patients with an abnormal endometrial biopsy [ Time Frame: after 3 years ]
  6. Pharmacogenetic analysis [ Time Frame: after 2 years ]
  7. Digital breast density analysis [ Time Frame: after 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00310531

Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer Identifier: NCT00310531    
Other Study ID Numbers: 91213
First Posted: April 4, 2006    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Raloxifene Hydrochloride
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents