PostmenopausePhase 3NCT00384072
Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women
A Phase 3 study testing bazedoxifene BZA-20 in people with Postmenopause and Osteoporosis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 20 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the effect of 20 mg of bazedoxifene in comparison to placebo on bone mineral density after 6 months of therapy in a population of postmenopausal Asian women. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Postmenopause, Osteoporosis
- What is being tested?
- bazedoxifene BZA-20
- How many people
- 500 participants
- Where
- 20 sitesin 3 countries
- Study dates
- May 2006to Sep 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Generally healthy Asian 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):
- Greater than 1 year but less than 5 years postmenopausal with at least one of the ospeoporosis risk factors
- Equal or greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (values of -1 and -2.5 are acceptable) with at least one osteoporosis risk factor
Who cannot join
- One (1) or more osteoporotic vertebral fractures (T4 - L4)
- BMD T-score at the lumbar spine or femoral neck less than -2.5
- Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
China9 sites
Study site
Beijing, 100700
Study site
Beijing, 100730
Study site
Nanjing, 210008
Study site
Shanghai, 100730
Study site
Shanghai, 200011
Study site
Shanghai, 200040
Study site
Tianjin, 200233
Study site
Tianjin, 300052
Study site
Tianjin, 300211
South Korea6 sites
Study site
Seoul, 110-744
Study site
Seoul, 120-752
Study site
Seoul, 133-792
Study site
Seoul, 135-710
Study site
Seoul, 138-736
Study site
Suwon, 443-721
Taiwan5 sites
Study site
Kaohsuing, 833
Study site
Kaoshsuing, 807
Study site
Tainan, 704
Study site
Taipei, 100
Study site
Tapei, 105
About this study
Official title: A Multicenter, Double Blind, Randomized, Placebo Controlled Study to Assess the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women
The purpose of this study is to evaluate the effect of 20 mg of bazedoxifene in comparison to placebo on bone mineral density after 6 months of therapy in a population of postmenopausal Asian women.
- Conditions
- Postmenopause, Osteoporosis
- Being tested
- bazedoxifene BZA-20
- Keywords
- postmenopausal, women, SERM, osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bazedoxifene BZA-20Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment
Secondary outcomes (3)
Additional BMD evaluation including total hip, femoral neck and trochanter at 6 months
Serum bone markers at 3 and 6 months
Lipid profile at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2006 (estimated)
- Study startMay 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For China, medinfo@wyeth.comTrial Manager, Principal investigator, For Taiwan, medinfo@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384072
- Sponsor's protocol ID
- 3068A1-303
- Status last verified
- May 2007
- First submitted
- 3 Oct 2006
- Last updated
- 28 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double Blind, Randomized, Placebo Controlled Study to Assess the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women
- ClinicalTrials.gov ID
- NCT00384072
- Acronym / sponsor ID
- 3068A1-303
- Conditions
- Postmenopause, Osteoporosis
- Keywords
- postmenopausal, women, SERM, osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 4 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of 20 mg of bazedoxifene in comparison to placebo on bone mineral density after 6 months of therapy in a population of postmenopausal Asian women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Generally healthy Asian 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):
Key exclusion criteria (3 listed)
- One (1) or more osteoporotic vertebral fractures (T4 - L4)
- BMD T-score at the lumbar spine or femoral neck less than -2.5
- Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bazedoxifene BZA-20 | Drug | – |
Primary outcome
The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment
3 secondary outcomes
Additional BMD evaluation including total hip, femoral neck and trochanter at 6 months
Serum bone markers at 3 and 6 months
Lipid profile at 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager principal investigator
For China, medinfo@wyeth.com
Trial Manager principal investigator
For Taiwan, medinfo@wyeth.com
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bazedoxifene BZA-20 in people with Postmenopause and Osteoporosis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 20 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2007.