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3-Year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-Menopausal Women

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00310531
First received: March 31, 2006
Last updated: July 6, 2009
Last verified: July 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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: 945
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

Ages Eligible for Study:   55 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310531

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

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00310531     History of Changes
Other Study ID Numbers: 91213, 306871
Study First Received: March 31, 2006
Last Updated: July 6, 2009
Health Authority: Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine

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

ClinicalTrials.gov processed this record on May 22, 2013