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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00310531

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Minerals Osteoporosis

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Raloxifene hydrochloride Raloxifene Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

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
Arm 1: Experimental	Drug: Menostar (Estradiol, BAY86-5435) Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
Arm 2: Active Comparator	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

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No publications provided

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

Additional relevant MeSH terms:

Estrogen Antagonists
Estrogens
Contraceptive Agents
Hormone Antagonists
Physiological Effects of Drugs
Estradiol valerate
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis
Bone Density Conservation Agents
Bone Diseases, Metabolic
Reproductive Control Agents

Estradiol 17 beta-cypionate
Selective Estrogen Receptor Modulators
Bone Diseases
Hormones
Pharmacologic Actions
Estradiol
Estrogen Receptor Modulators
Raloxifene
Musculoskeletal Diseases
Therapeutic Uses
Estradiol 3-benzoate
Polyestradiol phosphate

ClinicalTrials.gov processed this record on February 08, 2010