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

A Multicenter, Double Blind, Randomized, Placebo and Raloxifene Controlled Study to Assess Safety and Efficacy of TSE-424 (Bazedoxifene Acetate) in the Prevention of Postmenopausal Osteoporosis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00481169

Enrollment

1742

Registered

2007-06-01

Start date

2001-07-31

Completion date

2004-09-30

Last updated

2009-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

Postmenopausal Osteoporosis

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.

Detailed description

Primary objective: To evaluate the safety and efficacy of 3 doses of TSE-424 (bazedoxifene acetate), an investigational drug, in comparison with those of placebo and raloxifene in preventing osteoporosis in postmenopausal women. Secondary objective: To evaluate the effect of TSE-424 (bazedoxifene acetate), an investigational drug, in comparison with that of placebo and raloxifene on endometrium, metabolic parameters, vasomotor symptoms, adverse events, and quality of life. Samples will be collected for population pharmacokinetic (PK) analysis.

Interventions

DRUGBazedoxifene Acetate (TSE-424)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026