3-year Study of Menostar Versus Evista to Prevent Osteopo... | NCT00310531

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

NCT00310531

Sponsor

Bayer

Status

Completed

Last Update Posted

Dec 30, 2014Estimated

Enrollment

500Actual

Phase

Phase 3

Conditions

Osteopenia

Interventions

Menostar (Estradiol, BAY86-5435)
Raloxifene

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
306871

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.

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2004

Primary Completion Date

Not provided

Completion Date

Jun 2007Actual

First Submitted Date

Mar 31, 2006

First Submission Date that Met QC Criteria

Mar 31, 2006

First Posted Date

Apr 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2014

Last Update Posted Date

Dec 30, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Menostar (Estradiol, BAY86-5435)
Arm 2	Active Comparator		Drug: Raloxifene

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Menostar (Estradiol, BAY86-5435)	Drug	Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)	Arm 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Percentage change in Bone Mineral Density of the hip		after 3 years
Percentage change in biochemical markers of bone turnover		after 6 months
Proportion of patients with hot flushes

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D001851	Bone Diseases, Metabolic

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004958	Estradiol
D020849	Raloxifene Hydrochloride

Ancestor Terms

ID	Term
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided