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

Osteopenia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310531
• Other study ID #: 91213
• Secondary ID: 306871
• Status: Completed
• Phase: Phase 3
• First received: March 31, 2006
• Last updated: December 29, 2014
• Start date: February 2004
• Est. completion date: June 2007

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyEstonia: The State Agency of Medicine
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteopenia
• Osteoporosis

Intervention

Drug:
• Menostar (Estradiol, BAY86-5435)
Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
• Raloxifene
Raloxifene tbl. (60 mg/day)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in Bone Mineral Density at the lumbar spine		after 3 years
Secondary	Percentage change in Bone Mineral Density of the hip		after 3 years
Secondary	Percentage change in biochemical markers of bone turnover		after 6 months
Secondary	Proportion of patients with hot flushes		after 3 year
Secondary	Change in Women's Health Questionnaire		after 2 years
Secondary	Proportion of patients with an abnormal endometrial biopsy		after 3 years
Secondary	Pharmacogenetic analysis		after 2 years
Secondary	Digital breast density analysis		after 2 years

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