Study Evaluating Bazedoxifene Dose-Response in Japanese Patients With Postmenopausal Osteoporosis.
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00238745
Collaborator
(none)
375
43
Study Details
Study Description
Brief Summary
Dose-response in Japanese patients with postmenopausal osteoporosis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Official Title:
Bone Mineral Density Increase and Safety of TSE-424 Compared to Placebo in Osteoporotic Postmenopausal Women
Study Start Date
:
Aug 1, 2003
Actual Study Completion Date
:
Mar 1, 2007
Outcome Measures
Primary Outcome Measures
- Bone mineral density of lumbar spine (L1-L4) at 2 years. []
Secondary Outcome Measures
- Bone metabolic makers, bone fracture, bone mineral density of lumbar spine (L2-L4) and lip, lipid parameters, height and adverse events. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 85 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Must be postmenopausal and diagnosed as osteoporosis based on bone mineral density and/or vertebral fracture.
Exclusion Criteria:
- Diseases which possibly induce secondary osteoporosis or osteopenia and affect on bone metabolism.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
- Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00238745
Other Study ID Numbers:
- 3068A1-207
First Posted:
Oct 13, 2005
Last Update Posted:
Dec 20, 2007
Last Verified:
Dec 1, 2007
Keywords provided by ,
,
Additional relevant MeSH terms: