Study Evaluating TSE-424/Placebo/Raloxifene in Preventing Osteoporosis in Postmenopausal Women
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: Bazedoxifene Acetate (TSE-424) (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
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.
Clinical Details
Official title: 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
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The percent change from baseline in lumbar spine bone mineral density (BMD) after 24 months.
Secondary outcome: 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.
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.
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: July 2001
Last updated: May 30, 2007
|
