Home
Clinical Trials
Study Evaluating Bazedoxifene...

Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

NCT ID: NCT00205777

Last Updated: 2013-04-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

7609 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Evaluating Bazedoxifene Dose-Response in Japanese Patients With Postmenopausal Osteoporosis.

NCT00238745

Postmenopausal Osteoporosis

COMPLETED PHASE2

Study Evaluating TSE-424/Placebo/Raloxifene in Preventing Osteoporosis in Postmenopausal Women

NCT00481169

Osteoporosis

COMPLETED PHASE3

Switching From Oral Bisphosphonates to Bazedoxifene to Evaluate Effects on Bone Mineral Density in Postmenopausal Women

NCT02090400

Osteoporosis, Postmenopausal

COMPLETED PHASE4

Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis

NCT00542425

Osteoporosis

COMPLETED PHASE2

Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women

NCT01343004

Osteoporosis Postmenopausal Osteoporosis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type ACTIVE_COMPARATOR

Bazedoxifene Acetate

Intervention Type DRUG

BZA 20mg, daily, oral

B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo, daily, oral

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bazedoxifene Acetate

BZA 20mg, daily, oral

Intervention Type DRUG

Placebo

Placebo, daily, oral

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Must be at least 2 years postmenopausal
* Osteoporotic subjects without vertebral fracture who meet BMD criteria, or Osteoporotic subjects with vertebral fracture

Exclusion Criteria

* Diseases that may affect bone metabolism
* Vasomotor symptoms requiring treatment
* Known history or suspected cancer of the breast
* Active or past history of venous thromboembolic events

Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Huntsville, Alabama, United States

Site Status

Pfizer Investigational Site

Mobile, Alabama, United States

Site Status