Trial · NCT00205777
Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women
NCT00205777, Phase 3, Completed, Pfizer; results first posted 2013-04-10
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women. Trials, record NCT00205777. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00205777
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women
- NCT number
- NCT00205777
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 7,609 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Osteoporosis
- Interventions
- Bazedoxifene Acetate, Placebo
- First posted
- 2005-09-20
- Last updated
- 2013-04-10
- Results first posted
- 2013-04-10
Source ClinicalTrials.gov
Registered outcomes60
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With New Vertebral Fractures Through Month 36 | Baseline through Month 36 | New vertebral fracture: decrease in anterior, mid, or posterior vertebral (vt) height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture. |
| Primary | Percentage of Participants With New Vertebral Fractures Through Month 60 | Baseline through Month 60 | New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture. |
| Primary | Percentage of Participants With New Vertebral Fractures Through Month 84 | Baseline through Month 84 | New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture. |
| Secondary | Incidence of Breast Cancer Through Month 36 | Baseline through Month 36 | Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time). |
| Secondary | Incidence of Breast Cancer Through Month 60 | Baseline through Month 60 | Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time). |
| Secondary | Incidence of Breast Cancer Through Month 84 | Baseline through Month 84 | Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time). |
| Secondary | Percentage of Participants With New Clinical Vertebral Fractures Through Month 36 | Baseline through Month 36 | A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base. |
| Secondary | Percentage of Participants With New Clinical Vertebral Fractures Through Month 60 | Baseline through Month 60 | A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base. |
| Secondary | Percentage of Participants With New Clinical Vertebral Fractures Through Month 84 | Baseline through Month 84 | A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base. |
| Secondary | Number of Participants With Worsening Vertebral Fractures Through Month 36 | Baseline through Month 36 | A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline. |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 registered outcomesOutcomes60
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With New Vertebral Fractures Through Month 36 | Baseline through Month 36 | Intent-to-treat(ITT) population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With New Vertebral Fractures Through Month 60 | Baseline through Month 60 | ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With New Vertebral Fractures Through Month 84 | Baseline through Month 84 | Modified ITT(mITT) population of safety population category one(SP1) population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable.n=participants with specified baseline fracture status. | Percentage of participants | NUMBER |
| SECONDARY | Incidence of Breast Cancer Through Month 36 | Baseline through Month 36 | Safety Population 1 (SP1) included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Breast cancer per 1000-women years | NUMBER |
| SECONDARY | Incidence of Breast Cancer Through Month 60 | Baseline through Month 60 | SP1 included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Breast cancer per 1000-women years | NUMBER |
| SECONDARY | Incidence of Breast Cancer Through Month 84 | Baseline through Month 84 | SP1 included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Breast cancer per 1000-women years | NUMBER |
| SECONDARY | Percentage of Participants With New Clinical Vertebral Fractures Through Month 36 | Baseline through Month 36 | ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With New Clinical Vertebral Fractures Through Month 60 | Baseline through Month 60 | ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With New Clinical Vertebral Fractures Through Month 84 | Baseline through Month 84 | mITT population of SP1 population included all randomized participants who took at least 1 dose of test article and who had a vertebral radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Worsening Vertebral Fractures Through Month 36 | Baseline through Month 36 | ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Participants | NUMBER |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 outcomesResults by group619
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With New Vertebral Fractures Through Month 36 | Bazedoxifene 20 mg (Core+SE I) | No Prevalent Fracture (n=757,744,742,760) | 1.98 | 95% Confidence Interval 1.15 to 3.40 | Percentage of participants |
| Percentage of Participants With New Vertebral Fractures Through Month 36 | Bazedoxifene 40 mg (Core) | No Prevalent Fracture (n=757,744,742,760) | 2.14 | 95% Confidence Interval 1.25 to 3.67 | Percentage of participants |
| Percentage of Participants With New Vertebral Fractures Through Month 36 | Raloxifene 60 mg (Core) | No Prevalent Fracture (n=757,744,742,760) | 1.84 | 95% Confidence Interval 1.04 to 3.22 | Percentage of participants |
| Percentage of Participants With New Vertebral Fractures Through Month 36 | Placebo (Core+SE I+SE II) | No Prevalent Fracture (n=757,744,742,760) | 3.13 | 95% Confidence Interval 2.03 to 4.82 | Percentage of participants |
| Percentage of Participants With New Vertebral Fractures Through Month 36 | Bazedoxifene 20 mg (Core+SE I) | At Least 1 Prevalent Fracture (n=967,942,954,981) | 2.63 | 95% Confidence Interval 1.73 to 3.98 | Percentage of participants |
| Percentage of Participants With New Vertebral Fractures Through Month 36 | Bazedoxifene 40 mg (Core) | At Least 1 Prevalent Fracture (n=967,942,954,981) | 2.80 | 95% Confidence Interval 1.86 to 4.20 | Percentage of participants |
| Percentage of Participants With New Vertebral Fractures Through Month 36 | Raloxifene 60 mg (Core) | At Least 1 Prevalent Fracture (n=967,942,954,981) | 2.74 | 95% Confidence Interval 1.81 to 4.14 | Percentage of participants |
| Percentage of Participants With New Vertebral Fractures Through Month 36 | Placebo (Core+SE I+SE II) | At Least 1 Prevalent Fracture (n=967,942,954,981) | 4.80 | 95% Confidence Interval 3.52 to 6.52 | Percentage of participants |
| Percentage of Participants With New Vertebral Fractures Through Month 60 | Bazedoxifene 20 mg (Core+SE I) | No Prevalent Fracture (n=757,760,744) | 3.11 | 95% Confidence Interval 1.94 to 4.96 | Percentage of participants |
| Percentage of Participants With New Vertebral Fractures Through Month 60 | Placebo (Core+SE I+SE II) | No Prevalent Fracture (n=757,760,744) | 5.40 | 95% Confidence Interval 3.73 to 7.80 | Percentage of participants |
1 to 10 of 619Source ClinicalTrials.gov
See all 619 results by groupParticipant flow102
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Study (Up to 3 Years) | STARTED | Bazedoxifene 20 mg (Core+SE I) | 1,907 | |
| Core Study (Up to 3 Years) | STARTED | Bazedoxifene 40 mg (Core) | 1,904 | |
| Core Study (Up to 3 Years) | STARTED | Raloxifene 60 mg (Core) | 1,884 | |
| Core Study (Up to 3 Years) | STARTED | Placebo (Core+SE I+SE II) | 1,914 | |
| Core Study (Up to 3 Years) | STARTED | Bazedoxifene 40/20 mg (SE I) | 0 | |
| Core Study (Up to 3 Years) | STARTED | Bazedoxifene 20 mg (SE II) | 0 | |
| Core Study (Up to 3 Years) | TREATED | Bazedoxifene 20 mg (Core+SE I) | 1,886 | |
| Core Study (Up to 3 Years) | TREATED | Bazedoxifene 40 mg (Core) | 1,872 | |
| Core Study (Up to 3 Years) | TREATED | Raloxifene 60 mg (Core) | 1,849 | |
| Core Study (Up to 3 Years) | TREATED | Placebo (Core+SE I+SE II) | 1,885 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 participant flowAdverse events1,776
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | General disorders | Bazedoxifene 20 mg | 460 | 1,886 | |
| other | Abdominal pain | General disorders | Bazedoxifene 40/ 20 mg | 460 | 1,872 | |
| other | Abdominal pain | General disorders | Raloxifene 60 mg (Core Study) | 460 | 1,849 | |
| other | Abdominal pain | General disorders | Placebo | 509 | 1,885 | |
| other | Accidental injury | General disorders | Bazedoxifene 20 mg | 503 | 1,886 | |
| other | Accidental injury | General disorders | Bazedoxifene 40/ 20 mg | 449 | 1,872 | |
| other | Accidental injury | General disorders | Raloxifene 60 mg (Core Study) | 406 | 1,849 | |
| other | Accidental injury | General disorders | Placebo | 522 | 1,885 | |
| other | Asthenia | General disorders | Bazedoxifene 20 mg | 234 | 1,886 | |
| other | Asthenia | General disorders | Bazedoxifene 40/ 20 mg | 230 | 1,872 |
1 to 10 of 1,776Source ClinicalTrials.gov
See all 1,776 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bazedoxifene 20 mg | ||
| Total, all-cause mortality | Bazedoxifene 40/ 20 mg | ||
| Total, all-cause mortality | Raloxifene 60 mg (Core Study) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Bazedoxifene 20 mg | 1,818 | 1,886 |
| Total, other adverse events | Bazedoxifene 40/ 20 mg | 1,800 | 1,872 |
| Total, other adverse events | Raloxifene 60 mg (Core Study) | 1,775 | 1,849 |
| Total, other adverse events | Placebo | 1,823 | 1,885 |
| Total, serious adverse events | Bazedoxifene 20 mg | 507 | 1,886 |
| Total, serious adverse events | Bazedoxifene 40/ 20 mg | 468 | 1,872 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20569451 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Placebo (Core+SE I+SE II) vs Bazedoxifene 20 mg (SE II): Number of Participants With Worsening Vertebral Fractures Through Month 84 |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00205777
GET https://conductscience.org/api/trials/v1/NCT00205777/registered?page=2