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

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT00310531
Collaborator
(none)
500
Enrollment
2
Arms
40
Duration (Months)

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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 :
Feb 1, 2004
Actual Study Completion Date :
Jun 1, 2007

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Percentage change in Bone Mineral Density at the lumbar spine [after 3 years]

Secondary Outcome Measures

  1. Percentage change in Bone Mineral Density of the hip [after 3 years]

  2. Percentage change in biochemical markers of bone turnover [after 6 months]

  3. Proportion of patients with hot flushes [after 3 year]

  4. Change in Women's Health Questionnaire [after 2 years]

  5. Proportion of patients with an abnormal endometrial biopsy [after 3 years]

  6. Pharmacogenetic analysis [after 2 years]

  7. Digital breast density analysis [after 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 80 Years
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT00310531
Other Study ID Numbers:
  • 91213
  • 306871
First Posted:
Apr 4, 2006
Last Update Posted:
Dec 30, 2014
Last Verified:
Dec 1, 2014
Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Raloxifene Hydrochloride
Estradiol

Study Results

No Results Posted as of Dec 30, 2014