Trial · NCT00038467
Outcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study | Baseline up to Month 36 | Intent-to-treat (ITT) population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received. | probability of DFS | NUMBER |
| SECONDARY | Overall Survival (OS) at Month 36 Post-Randomization: Main Study | Baseline up to Month 120 | ITT population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received. | probability of OS | NUMBER |
| SECONDARY | Number of Events of Second Breast Cancer in Contralateral Breast: Main Study | Baseline up to Month 120 | ITT population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received. | events | NUMBER |
| SECONDARY | Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study | Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment | Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Femoral Neck and Femoral Wards Bone Mineral Density (BMD) at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study | Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment | Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received. | percent change | MEAN |
| SECONDARY | Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) T-scores at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study | Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment | Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received. | T-score | MEAN |
| SECONDARY | Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment | As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available. | percentage of baseline concentration | GEOMETRIC_MEAN |
| SECONDARY | Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment | As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available. | percentage of baseline concentration | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment | As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available. | percentage of baseline concentration | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment | As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available. | percentage of baseline concentration | GEOMETRIC_MEAN |
| SECONDARY | Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment | As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available. | percentage of baseline concentration | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Fracture: Bone Metabolism Sub-study | Baseline up to 24 months post-treatment | As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. | participants | NUMBER |
| SECONDARY | Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization | ITT population for QoL sub-study included all randomized participants with available data for any given endpoint and were grouped according to randomized treatment, irrespective of whether they were actually treated or not. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Functional Assessment of Cancer Therapy - Endocrine Subscale (FACT-ES) Total Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization | ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Total Functional Assessment of Cancer Therapy - General Breast and Endocrine (FACT-GBE) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization | ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Physical Well-Being (PWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization | ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Social/Family Well-Being (SWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization | ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Relationship With Doctor (RWD) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Substudy | Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization | ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Emotional Well-Being (EWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization | ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Functional Well-Being (FWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study | Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization | ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation. | units on a scale | 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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