Trial · NCT00556374
Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy
NCT00556374, Phase 3, Completed, Amgen; results first posted 2015-11-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy. Trials, record NCT00556374. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00556374
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy
- NCT number
- NCT00556374
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,420 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Breast Cancer
- Interventions
- Placebo, Denosumab, Non-steroidal aromatase inhibitor therapy, Zoledronic Acid, Standard of Care
- First posted
- 2007-11-12
- Last updated
- 2023-07-27
- Other registries' IDs
- eudract:2005-005275-15
- Results first posted
- 2015-11-06
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Clinical Fracture | From randomization until the primary analysis cut-off date of 26 March 2014; maximum time on main study at the cut-off was 87 months | The time to first on-study clinical fracture was defined as the number of days from randomization to the date of the x-ray confirming the clinical fracture. A clinical fracture is any clinically evident fracture with associated symptoms and confirmed by x-ray. Participants who died or withdrew without experiencing a clinical fracture were censored at the date of last contact or study termination whichever was earlier. |
| Secondary | Percent Change From Baseline in Total Lumbar Spine Bone Mineral Density (BMD) at Month 36 at Pre-selected Sites | Baseline and Month 36 | Bone mineral density was assessed by dual x-ray absorptiometry. |
| Secondary | Percent Change From Baseline in Total Hip BMD at Month 36 at Pre-selected Sites | Baseline and Month 36 | Bone mineral density was assessed by dual x-ray absorptiometry. |
| Secondary | Percent Change From Baseline in Femoral Neck BMD at Month 36 at Pre-selected Sites | Baseline and Month 36 | Bone mineral density was assessed by dual x-ray absorptiometry. |
| Secondary | Number of Participants With New Vertebral Fractures | 36 months | Assessment of vertebral fractures was performed by an expert radiologist at the central imaging center using a semiquantitative grading scale: Grade 1, 20% to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2, 25% to 40% reduction in height; Grade 3, greater than 40% reduction in height. A new vertebral fracture was defined as a fracture in a previously undeformed vertebrae including new compression fractures, defined as those compression fractures having a decrease in total anterior or posterior height of at least 25% from baseline. New vertebral fractures includes morphometric vertebral fractures identified from on study x-rays and clinical vertebral fractures confirmed by x-rays. |
| Secondary | Number of Participants With New or Worsening Vertebral Fractures | 36 months | Assessment of vertebral fractures was performed by an expert radiologist at the central imaging center using a semiquantitative grading scale: Grade 1, 20% to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2, 25% to 40% reduction in height; Grade 3, greater than 40% reduction in height. A new vertebral fracture was defined as a fracture in a previously undeformed vertebrae including new compression fractures, defined as those compression fractures having a decrease in total anterior or posterior height of at least 25% from baseline. New vertebral fractures includes morphometric vertebral fractures identified from on study x-rays and clinical vertebral fractures confirmed by x-rays. Worsening of pre-existing fractures was defined as an increase in fracture severity of at least 1 grade on the semiquantitative scale. |
| Secondary | Disease-free Survival (DFS) | From randomization until the DFS data cut-off date of 15 September 2015; maximum time on main study at the cut-off was 102 months | DFS was defined as the time interval from the randomization date to the date of first evidence of local or distant metastases, contra-lateral breast cancer, secondary carcinoma, or death from any cause (whichever occurred first). Participants last known to be alive, who did not experience recurrence of disease, were censored at their last contact date or at the data cut-off date whichever came first. |
| Secondary | Bone Metastases-free Survival (BMFS) | From randomization until end of main study, maximum time on main study was 152 months | BMFS was defined as the time interval from randomization to first occurrence of bone metastasis or death from any cause, whichever comes first. Participants last known to be alive, who did not experience bone metastasis, were censored at their last assessment (i.e., bone scan) date or at the last contact date, whichever comes first. |
| Secondary | Overall Survival (OS) | Randomization until end of main study, maximum duration of main study was 152 months | OS was defined as the time from randomization to death from any cause. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Clinical Fracture | From randomization until the primary analysis cut-off date of 26 March 2014; maximum time on main study at the cut-off was 87 months | Full Analysis Set: all randomized participants | Days | MEDIAN |
| SECONDARY | Percent Change From Baseline in Total Lumbar Spine Bone Mineral Density (BMD) at Month 36 at Pre-selected Sites | Baseline and Month 36 | BMD Analysis Set: all participants with evaluable lumbar spine BMD values at Baseline and Month 36 | Percent Change in BMD | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Hip BMD at Month 36 at Pre-selected Sites | Baseline and Month 36 | BMD Analysis Set: all participants with total hip BMD evaluable values at Baseline and Month 36 | Percent Change in BMD | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Femoral Neck BMD at Month 36 at Pre-selected Sites | Baseline and Month 36 | BMD Analysis Set: all participants with evaluable femoral neck BMD values at Baseline and Month 36 | Percent Change in BMD | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With New Vertebral Fractures | 36 months | Vertebral Fracture Analysis Set: all participants with a Baseline and at least one post-baseline vertebral x-ray prior to or at Month 36 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With New or Worsening Vertebral Fractures | 36 months | Vertebral Fracture Analysis Set: all participants with a Baseline and at least one post-baseline vertebral x-ray prior to or at Month 36 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease-free Survival (DFS) | From randomization until the DFS data cut-off date of 15 September 2015; maximum time on main study at the cut-off was 102 months | Full Analysis Set: all randomized participants | Days | MEDIAN |
| SECONDARY | Bone Metastases-free Survival (BMFS) | From randomization until end of main study, maximum time on main study was 152 months | Full Analysis Set: all randomized participants | Days | MEDIAN |
| SECONDARY | Overall Survival (OS) | Randomization until end of main study, maximum duration of main study was 152 months | Full analysis set: all randomized participants | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Clinical Fracture | Placebo | NA | 95% Confidence Interval NA to NA | Days | |
| Time to First Clinical Fracture | Denosumab | NA | 95% Confidence Interval NA to NA | Days | |
| Percent Change From Baseline in Total Lumbar Spine Bone Mineral Density (BMD) at Month 36 at Pre-selected Sites | Placebo | -2.75 | 95% Confidence Interval -3.44 to -2.07 | Percent Change in BMD | |
| Percent Change From Baseline in Total Lumbar Spine Bone Mineral Density (BMD) at Month 36 at Pre-selected Sites | Denosumab | 7.27 | 95% Confidence Interval 6.56 to 7.98 | Percent Change in BMD | |
| Percent Change From Baseline in Total Hip BMD at Month 36 at Pre-selected Sites | Placebo | -3.32 | 95% Confidence Interval -4.06 to -2.58 | Percent Change in BMD | |
| Percent Change From Baseline in Total Hip BMD at Month 36 at Pre-selected Sites | Denosumab | 4.60 | 95% Confidence Interval 3.85 to 5.35 | Percent Change in BMD | |
| Percent Change From Baseline in Femoral Neck BMD at Month 36 at Pre-selected Sites | Placebo | -3.10 | 95% Confidence Interval -3.72 to -2.48 | Percent Change in BMD | |
| Percent Change From Baseline in Femoral Neck BMD at Month 36 at Pre-selected Sites | Denosumab | 3.41 | 95% Confidence Interval 2.78 to 4.04 | Percent Change in BMD | |
| Number of Participants With New Vertebral Fractures | Placebo | 49 | Participants | ||
| Number of Participants With New Vertebral Fractures | Denosumab | 27 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 1,709 | |
| Overall Study | STARTED | Denosumab | 1,711 | |
| Overall Study | Received Study Drug in the Double-blind Phase | Placebo | 1,699 | |
| Overall Study | Received Study Drug in the Double-blind Phase | Denosumab | 1,700 | |
| Overall Study | Continued Into the Open-Label Phase | Placebo | 268 | |
| Overall Study | Continued Into the Open-Label Phase | Denosumab | 3 | |
| Overall Study | Safety Analysis Set | Placebo | 1,690 | |
| Overall Study | Safety Analysis Set | Denosumab | 1,709 | |
| Overall Study | COMPLETED | Placebo | 1,242 | |
| Overall Study | COMPLETED | Denosumab | 1,362 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events2,512
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 | Arthralgia | Musculoskeletal and connective tissue disorders | Double-blind Phase: Placebo | 446 | 1,690 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Double-blind Phase: Denosumab | 441 | 1,709 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Open-label Phase: Placebo/Denosumab | 0 | 245 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Open-label Phase: Denosumab/Denosumab | 0 | 1 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Double-blind Phase: Placebo | 146 | 1,690 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Double-blind Phase: Denosumab | 151 | 1,709 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Open-label Phase: Placebo/Denosumab | 0 | 245 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Open-label Phase: Denosumab/Denosumab | 0 | 1 | |
| other | Bone pain | Musculoskeletal and connective tissue disorders | Double-blind Phase: Placebo | 111 | 1,690 | |
| other | Bone pain | Musculoskeletal and connective tissue disorders | Double-blind Phase: Denosumab | 139 | 1,709 |
1 to 10 of 2,512Source ClinicalTrials.gov
See all 2,512 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-blind Phase: Placebo | ||
| Total, all-cause mortality | Double-blind Phase: Denosumab | ||
| Total, all-cause mortality | Open-label Phase: Placebo/Denosumab | ||
| Total, all-cause mortality | Open-label Phase: Denosumab/Denosumab | ||
| Total, other adverse events | Double-blind Phase: Placebo | 838 | 1,690 |
| Total, other adverse events | Double-blind Phase: Denosumab | 882 | 1,709 |
| Total, other adverse events | Open-label Phase: Placebo/Denosumab | 0 | 245 |
| Total, other adverse events | Open-label Phase: Denosumab/Denosumab | 0 | 1 |
| Total, serious adverse events | Double-blind Phase: Placebo | 515 | 1,690 |
| Total, serious adverse events | Double-blind Phase: Denosumab | 521 | 1,709 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Denosumab vs Placebo: Number of Participants With New or Worsening Vertebral Fractures | Trial comparisons |
| Denosumab vs Placebo: Number of Participants With New Vertebral Fractures | 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/NCT00556374
GET https://conductscience.org/api/trials/v1/NCT00556374/events?page=2