Trial · NCT00869206
Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement
NCT00869206, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2018-11-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement. Trials, record NCT00869206. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00869206
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement
- NCT number
- NCT00869206
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,822 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Breast Adenocarcinoma, DS Stage I Plasma Cell Myeloma, DS Stage II Plasma Cell Myeloma, Metastatic Malignant Neoplasm to the Bone, Pain, Musculoskeletal Complication, Urinary Complications
- Interventions
- zoledronic acid
- First posted
- 2009-03-25
- Last updated
- 2018-11-07
- Results first posted
- 2018-11-07
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With at Least One Skeletal-related Event (SRE) Within 2 Years After Randomization | 2 years | To determine whether every-12-week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma involving bone, as measured by the proportion of patients who would have experienced at least one skeletal related event within 24 months after randomization. |
| Secondary | Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire | from baseline up to 2 years | To compare pain scores (Brief Pain Inventory) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The change scores were evaluated in a general linear model with repeated measures for treatment effect and the time trend with patient-specific characteristics being adjusted for the mean interference score. Specifically the difference in score change per 4 weeks for Arm I using Arm II as the reference is reported. The score of the BPI questionnaire ranges from 0 being no pain to 10 being the most pain. The average score is reported for each arm below. |
| Secondary | Average ECOG Performance Status | from baseline up to 2 years | To compare functional status (ECOG performance status) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The change scores were evaluated in a general linear model with repeated measures for treatment effect and the time trend with patient-specific characteristics being adjusted. Specifically the difference in score change per 4 weeks for Arm I using Arm II as the reference is reported. ECOG performance status is a measurement of a patients disability ranging from 0, fully active and able to carry out all pre disease performance without restriction, to 5, dead. The average performance status is reported below by arm. |
| Secondary | Incidence of Osteonecrosis of the Jaw | from baseline up to 2 years | To compare the incidence of osteonecrosis of the jaw in patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The percentage of participants with osteonecrosis is reported here. |
| Secondary | Incidence of Renal Dysfunction | from baseline up to 2 years | To compare the incidence of renal dysfunction of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The percentage of patients with renal dysfunction, defined as grade 3 or grade 4 increased creatinine (Common Terminology Criteria for Adverse Events version 3.0), will be reported here. |
| Secondary | Skeletal Morbidity Rate | from baseline up to 2 years | To compare the skeletal morbidity rate, defined as the number of skeletal-related events per year, of patients receiving every 12 week dosing to those receiving every 4 week dosing. |
| Secondary | Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Breast Cancer) | from baseline up to 2 years | To compare the suppression of serum markers of bone resorption of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The number of patients with high \& low CTX values by arm will be reported here. |
| Secondary | Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Breast Cancer | from baseline up to 24 months | To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with breast cancer, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization. |
| Secondary | Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Prostate Cancer | from baseline up to 24 months | To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with prostate cancer, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization. |
| Secondary | Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Multiple Myeloma | from baseline up to 24 months | To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with multiple myeloma, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 at Least One Skeletal-related Event (SRE) Within 2 Years After Randomization | 2 years | All patients that were eligible and completed treatment were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire | from baseline up to 2 years | 1766 patients completed treatment and were analyzed. | score on a scale | MEAN |
| SECONDARY | Average ECOG Performance Status | from baseline up to 2 years | 1766 patients completed treatment and were analyzed. | score on a scale | MEAN |
| SECONDARY | Incidence of Osteonecrosis of the Jaw | from baseline up to 2 years | 1766 patients completed treatment and were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Incidence of Renal Dysfunction | from baseline up to 2 years | 1689 patients completed treatment and were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Skeletal Morbidity Rate | from baseline up to 2 years | 1766 patients were treated and analyzed. | SRE's per year | MEAN |
| SECONDARY | Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Breast Cancer) | from baseline up to 2 years | 266 breast cancer patients who were treated and included in this portion of the substudy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Breast Cancer | from baseline up to 24 months | 820 patients completed treatment and were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Prostate Cancer | from baseline up to 24 months | 660 patients completed treatment and were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Multiple Myeloma | from baseline up to 24 months | 265 patient completed treatment and were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group30
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 at Least One Skeletal-related Event (SRE) Within 2 Years After Randomization | Arm I (Zoledronic Acid Every 4 Weeks) | 67.6 | percentage of participants | ||
| Percentage of Participants With at Least One Skeletal-related Event (SRE) Within 2 Years After Randomization | Arm II (Zoledronic Acid Every 12 Weeks) | 67.9 | percentage of participants | ||
| Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire | Arm I (Zoledronic Acid Every 4 Weeks) | 2.06 | Standard Error 0.14 | score on a scale | |
| Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire | Arm II (Zoledronic Acid Every 12 Weeks) | 2.09 | Standard Error 0.14 | score on a scale | |
| Average ECOG Performance Status | Arm I (Zoledronic Acid Every 4 Weeks) | 0.82 | Standard Error 0.042 | score on a scale | |
| Average ECOG Performance Status | Arm II (Zoledronic Acid Every 12 Weeks) | 0.84 | Standard Error 0.042 | score on a scale | |
| Incidence of Osteonecrosis of the Jaw | Arm I (Zoledronic Acid Every 4 Weeks) | 2.0 | percentage of participants | ||
| Incidence of Osteonecrosis of the Jaw | Arm II (Zoledronic Acid Every 12 Weeks) | 1.0 | percentage of participants | ||
| Incidence of Renal Dysfunction | Arm I (Zoledronic Acid Every 4 Weeks) | 1.2 | percentage of participants | ||
| Incidence of Renal Dysfunction | Arm II (Zoledronic Acid Every 12 Weeks) | .5 | percentage of participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Zoledronic Acid Every 4 Weeks) | 911 | |
| Overall Study | STARTED | Arm II (Zoledronic Acid Every 12 Weeks) | 911 | |
| Overall Study | COMPLETED | Arm I (Zoledronic Acid Every 4 Weeks) | 882 | |
| Overall Study | COMPLETED | Arm II (Zoledronic Acid Every 12 Weeks) | 884 | |
| Overall Study | NOT COMPLETED | Arm I (Zoledronic Acid Every 4 Weeks) | 29 | |
| Overall Study | NOT COMPLETED | Arm II (Zoledronic Acid Every 12 Weeks) | 27 |
Source ClinicalTrials.gov
Adverse events914
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 | Blood disorder | Blood and lymphatic system disorders | Arm I (Zoledronic Acid Every 4 Weeks) | 2 | 879 | 2 |
| other | Blood disorder | Blood and lymphatic system disorders | Arm II (Zoledronic Acid Every 12 Weeks) | 2 | 868 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm I (Zoledronic Acid Every 4 Weeks) | 10 | 879 | 14 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm II (Zoledronic Acid Every 12 Weeks) | 7 | 868 | 8 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm I (Zoledronic Acid Every 4 Weeks) | 98 | 879 | 195 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm II (Zoledronic Acid Every 12 Weeks) | 92 | 868 | 206 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm I (Zoledronic Acid Every 4 Weeks) | 16 | 879 | 37 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm II (Zoledronic Acid Every 12 Weeks) | 11 | 868 | 29 |
| other | Lymphatic disorder | Blood and lymphatic system disorders | Arm I (Zoledronic Acid Every 4 Weeks) | 3 | 879 | 5 |
| other | Lymphatic disorder | Blood and lymphatic system disorders | Arm II (Zoledronic Acid Every 12 Weeks) | 1 | 868 | 1 |
1 to 10 of 914Source ClinicalTrials.gov
See all 914 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Zoledronic Acid Every 4 Weeks) | 41 | 879 |
| Total, all-cause mortality | Arm II (Zoledronic Acid Every 12 Weeks) | 42 | 868 |
| Total, other adverse events | Arm I (Zoledronic Acid Every 4 Weeks) | 779 | 879 |
| Total, other adverse events | Arm II (Zoledronic Acid Every 12 Weeks) | 750 | 868 |
| Total, serious adverse events | Arm I (Zoledronic Acid Every 4 Weeks) | 96 | 879 |
| Total, serious adverse events | Arm II (Zoledronic Acid Every 12 Weeks) | 103 | 868 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA037447 | Cancer and Leukemia Group B CCOP Research Base | BERTAGNOLLI, MONICA M; PASKETT, ELECTRA D. | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2015 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Multiple Myeloma 4 Weeks vs Multiple Myeloma 12 Weeks: Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Multiple Myeloma | Trial comparisons |
| Prostate Cancer 4 Weeks vs Prostate Cancer 12 Weeks: Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Prostate Cancer | Trial comparisons |
| Arm I (Zoledronic Acid Every 4 Weeks) vs Arm II (Zoledronic Acid Every 12 Weeks): deaths from any cause | Trial comparisons |
| Breast Cancer 4 Weeks vs Breast Cancer 12 Weeks: Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Breast Cancer | Trial comparisons |
| Arm I (Zoledronic Acid Every 4 Weeks) vs Arm II (Zoledronic Acid Every 12 Weeks): 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/NCT00869206
GET https://conductscience.org/api/trials/v1/NCT00869206/results?page=2