Trial · NCT00009945
Clodronate With or Without Chemotherapy and/or Hormonal Therapy in Treating Women With Stage I or Stage II Breast Cancer
NCT00009945, Phase 3, Completed, NSABP Foundation Inc; results first posted 2017-11-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clodronate With or Without Chemotherapy and/or Hormonal Therapy in Treating Women With Stage I or Stage II Breast Cancer. Trials, record NCT00009945. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00009945
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clodronate With or Without Chemotherapy and/or Hormonal Therapy in Treating Women With Stage I or Stage II Breast Cancer
- NCT number
- NCT00009945
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,323 participants, actual
- Lead sponsor
- NSABP Foundation Inc
- Conditions
- Breast Cancer
- Interventions
- clodronate, placebo
- First posted
- 2003-01-27
- Last updated
- 2017-12-13
- Results first posted
- 2017-11-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Free Survival. | 8 years | Time to first event where an event is any recurrences, 2nd primary or death to determine the percentage of patients disease free at 8 years |
| Secondary | Skeletal Metastasis Free Survival | 8 years | Time from randomization to first diagnosis of skeletal metastasis to determine the percentage of patient free of skeletal metastasis at 8 years |
| Secondary | Overall Survival | 8 years | Time from randomization to any death to determine the percentage of patients alive at 8 years |
| Secondary | Relapse Free Survival | 8 years | Time from randomization to any local, regional, or distant recurrence of breast cancer to determine the percentage of patients relapse free at 8 years |
| Secondary | Incidence of Non-skeletal Metastasis | 8 years | Time from randomization to incidence of non-skeletal metastasis to determine the percentage of patients free from non-skeletal metastasis at 8 years |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Free Survival. | 8 years | percentage of patients | NUMBER | |
| SECONDARY | Skeletal Metastasis Free Survival | 8 years | percentage of patients | NUMBER | |
| SECONDARY | Overall Survival | 8 years | percentage of patients | NUMBER | |
| SECONDARY | Relapse Free Survival | 8 years | percentage of patients | NUMBER | |
| SECONDARY | Incidence of Non-skeletal Metastasis | 8 years | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Free Survival. | Arm 1: Clodronate | 81.0 | percentage of patients | ||
| Disease Free Survival. | Arm 2: Placebo | 79.6 | percentage of patients | ||
| Skeletal Metastasis Free Survival | Arm 1: Clodronate | 95.7 | percentage of patients | ||
| Skeletal Metastasis Free Survival | Arm 2: Placebo | 94.6 | percentage of patients | ||
| Overall Survival | Arm 1: Clodronate | 90.6 | percentage of patients | ||
| Overall Survival | Arm 2: Placebo | 89.3 | percentage of patients | ||
| Relapse Free Survival | Arm 1: Clodronate | 89.9 | percentage of patients | ||
| Relapse Free Survival | Arm 2: Placebo | 88.3 | percentage of patients | ||
| Incidence of Non-skeletal Metastasis | Arm 1: Clodronate | 94.8 | percentage of patients | ||
| Incidence of Non-skeletal Metastasis | Arm 2: Placebo | 93.2 | percentage of patients |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: Clodronate | 1,662 | |
| Overall Study | STARTED | Arm 2: Placebo | 1,661 | |
| Overall Study | COMPLETED | Arm 1: Clodronate | 1,655 | |
| Overall Study | COMPLETED | Arm 2: Placebo | 1,656 | |
| Overall Study | NOT COMPLETED | Arm 1: Clodronate | 7 | |
| Overall Study | NOT COMPLETED | Arm 2: Placebo | 5 |
Source ClinicalTrials.gov
Adverse events274
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 | Neutrophil count decreased | Investigations | Clodronate | 73 | 1,612 | |
| other | Neutrophil count decreased | Investigations | Placebo | 107 | 1,623 | |
| serious | Abdominal pain | Gastrointestinal disorders | Clodronate | 8 | 1,612 | |
| serious | Abdominal pain | Gastrointestinal disorders | Placebo | 4 | 1,623 | |
| serious | Acidosis | Metabolism and nutrition disorders | Clodronate | 1 | 1,612 | |
| serious | Acidosis | Metabolism and nutrition disorders | Placebo | 0 | 1,623 | |
| serious | Activated partial thromboplastin time prolonged | Investigations | Clodronate | 2 | 1,612 | |
| serious | Activated partial thromboplastin time prolonged | Investigations | Placebo | 0 | 1,623 | |
| serious | Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Clodronate | 1 | 1,612 | |
| serious | Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 1,623 |
1 to 10 of 274Source ClinicalTrials.gov
See all 274 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clodronate | 5 | 1,612 |
| Total, all-cause mortality | Placebo | 12 | 1,623 |
| Total, other adverse events | Clodronate | 73 | 1,612 |
| Total, other adverse events | Placebo | 107 | 1,623 |
| Total, serious adverse events | Clodronate | 340 | 1,612 |
| Total, serious adverse events | Placebo | 350 | 1,623 |
Source ClinicalTrials.gov
Papers5
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 |
|---|---|
| Clodronate vs Placebo: deaths from any cause | Trial comparisons |
| Clodronate vs Placebo: serious adverse events | 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/NCT00009945
GET https://conductscience.org/api/trials/v1/NCT00009945/events?page=2