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

Condition(s) targeted: Osteopenia

Intervention: Menostar (SH P00577 E) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Schering Pharma AG, Germany, Medical Affairs, Study Director, Affiliation: T. +49 30 468 11800

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.

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 design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Percentage change in Bone Mineral Density at the lumbar spine

Secondary outcome:

Percentage change in Bone Mineral Density at the hip

Percentage change in biochemical markers of bone turnover

Proportion of patients with hot flushes

Women's Health Questionnaire

Proportion of patients with an abnormal endometrial biopsy

Arthralgia questionnaire

Pharmacogenetic analysis

Digital breast density analysis

Time Frame for all secondary outcomes: 3 years (3 x 13 cycles à 28 days)

Detailed description: Number of arms: 2

1. (MENOSTAR PATCH) SH P00577 E: Transdermal system (TDS) worn for 1 week and SH K00718 P: placebo capsules (containing placebo tablet) or

2. (MENOSTAR PLACEBO PATCH) SH P00577 PE: Matching placebo patch and (Evista) SH K00718 A containing a raloxifene hydrochloride 60 mg tablet)

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.

Minimum age: 55 Years. Maximum age: 80 Years. Gender(s): Female.

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)

Click here and search for drug information provided by the FDA

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product

Starting date: February 2004
Ending date: June 2007
Last updated: October 11, 2007