NCT00481169

Brief Summary

The purpose of this study is to determine whether TSE-424 (bazedoxifene acetate), an investigational drug, is safe and effective in the prevention of osteoporosis in postmenopausal women.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,742

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2001

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2007

Completed
Last Updated

August 21, 2009

Status Verified

August 1, 2009

Enrollment Period

3 years

First QC Date

May 30, 2007

Last Update Submit

August 20, 2009

Conditions

Osteoporosis

Keywords

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • The percent change from baseline in lumbar spine bone mineral density (BMD) after 24 months.

    24 months

Secondary Outcomes (1)

  • Additional BMD evaluation including total hip, femoral neck and trochanter at months 6, 12, 18 and 24. Serum bone markers at months 3, 6, 9, 12, 18 and 24. Lipid panel at months 3, 6, 12, 18 and 24.

    Up to 24 months

Interventions

Bazedoxifene Acetate (TSE-424)DRUG

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Generally healthy women 45 years of age or older who are at least 1 year postmenopausal.
  • Subjects must qualify for one of the following categories (a or b): a) Greater than 1 year but less than 5 years postmenopausal with at least one of the osteoporosis risk factors. b) Greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (inclusive) with at least one osteoporosis risk factor.

You may not qualify if:

  • One (1) or more osteoporotic vertebral fractures (T4-L4).
  • Diseases that may affect bone metabolism.
  • Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OsteoporosisOsteoporosis, Postmenopausal

Interventions

bazedoxifene

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2007

First Posted

June 1, 2007

Study Start

July 1, 2001

Primary Completion

July 1, 2004

Study Completion

September 1, 2004

Last Updated

August 21, 2009

Record last verified: 2009-08