Trial · NCT00205777
Outcomes60
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 60
Download this page as JSON| 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 |
| SECONDARY | Number of Participants With Worsening 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. | Participants | NUMBER |
| SECONDARY | Number of Participants With Worsening 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. | Participants | NUMBER |
| SECONDARY | Percentage of Participants With Non-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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Non-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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Non-vertebral Fractures Through Month 84 | Baseline through Month 84 | mITT population of 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. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Height at Month 36 | Baseline, 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)=participants evaluable for this measure. | millimeter (mm) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Height at Month 60 | Baseline, 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. | mm | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Height at Month 84 | Baseline, Month 84 | mITT population of 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) signifies those participants evaluable for this measure. | mm | MEAN |
| SECONDARY | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Baseline, Months 6, 12, 18, 24, 36 | ITT population included all randomized participants who took at least 1 dose of test article; had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Baseline, Month 48, 60 | mITT population of SP1 population:randomized participants who took at least 1 dose of test article; had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group. | Percent change | LEAST_SQUARES_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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