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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00310531

Enrollment

500

Registered

2006-04-04

Start date

2004-02-29

Completion date

2007-06-30

Last updated

2014-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia

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.

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.

Interventions

DRUGMenostar (Estradiol, BAY86-5435)

Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)

DRUGRaloxifene

Raloxifene tbl. (60 mg/day)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

55 Years to 80 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Percentage change in Bone Mineral Density at the lumbar spine	after 3 years

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026