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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00310531
First Posted: April 4, 2006
Last Update Posted: December 30, 2014
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.
Information provided by (Responsible Party):
Bayer
  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.

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

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Bayer:

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

Secondary Outcome 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 ]

Enrollment: 500
Study Start Date: February 2004
Study Completion Date: June 2007
Arms Assigned Interventions
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)

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.
  Eligibility

Information from the National Library of Medicine

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

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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00310531


Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00310531     History of Changes
Other Study ID Numbers: 91213
306871
First Submitted: March 31, 2006
First Posted: April 4, 2006
Last Update Posted: December 30, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Estradiol
Polyestradiol phosphate
Raloxifene Hydrochloride
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Estrogen Antagonists
Hormone Antagonists
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents