TriangleNCT00869206 · STUDY IN CONTEXT
Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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.
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.
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.
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
Brief Pain Inventory · Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- qol key
- qol-0001
- source section id
- NCT00869206-om-0001
- source outcome index
- 1
- instrument
- Brief Pain Inventory
- instrument basis
- matched 'brief pain inventory' in the study's own wording
- scale title
- Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire
- measure definition
- 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.
- time frame
- from baseline up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- 1766 patients completed treatment and were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- trial label
- Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 1
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- outcome key
- om-0000
- source section id
- NCT00869206-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants With at Least One Skeletal-related Event (SRE) Within 2 Years After Randomization
- endpoint definition
- 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.
- time origin
- 2 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients that were eligible and completed treatment were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- outcome key
- om-0001
- source section id
- NCT00869206-om-0001
- source outcome index
- 1
- endpoint
- Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire
- endpoint definition
- 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.
- time origin
- from baseline up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 1766 patients completed treatment and were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- outcome key
- om-0002
- source section id
- NCT00869206-om-0002
- source outcome index
- 2
- endpoint
- Average ECOG Performance Status
- endpoint definition
- 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.
- time origin
- from baseline up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 1766 patients completed treatment and were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- outcome key
- om-0003
- source section id
- NCT00869206-om-0003
- source outcome index
- 3
- endpoint
- Incidence of Osteonecrosis of the Jaw
- endpoint definition
- 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.
- time origin
- from baseline up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 1766 patients completed treatment and were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- outcome key
- om-0004
- source section id
- NCT00869206-om-0004
- source outcome index
- 4
- endpoint
- Incidence of Renal Dysfunction
- endpoint definition
- 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.
- time origin
- from baseline up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 1689 patients completed treatment and were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- outcome key
- om-0005
- source section id
- NCT00869206-om-0005
- source outcome index
- 5
- endpoint
- Skeletal Morbidity Rate
- endpoint definition
- 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.
- time origin
- from baseline up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 1766 patients were treated and analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm I (Zoledronic Acid Every 4 Weeks)
- regimen
- Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 911
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00869206-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm II (Zoledronic Acid Every 12 Weeks)
- regimen
- Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 911
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00869206-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm I (Zoledronic Acid Every 4 Weeks)
- regimen
- Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 882
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00869206-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm II (Zoledronic Acid Every 12 Weeks)
- regimen
- Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 884
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00869206-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm I (Zoledronic Acid Every 4 Weeks)
- regimen
- Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 882
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00869206-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm II (Zoledronic Acid Every 12 Weeks)
- regimen
- Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 884
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00869206-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm I (Zoledronic Acid Every 4 Weeks)
- regimen
- Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 882
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00869206-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm II (Zoledronic Acid Every 12 Weeks)
- regimen
- Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 884
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00869206-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Arm I (Zoledronic Acid Every 4 Weeks)
- regimen
- Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 852
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00869206-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Arm II (Zoledronic Acid Every 12 Weeks)
- regimen
- Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 837
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00869206-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Arm I (Zoledronic Acid Every 4 Weeks)
- regimen
- Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 882
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00869206-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Arm II (Zoledronic Acid Every 12 Weeks)
- regimen
- Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 884
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00869206-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- harm key
- EG000
- source section id
- NCT00869206-ae
- event group key
- EG000
- event group label
- Arm I (Zoledronic Acid Every 4 Weeks)
- serious affected
- 96
- serious at risk
- 879
- other affected
- 779
- other at risk
- 879
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- harm key
- EG001
- source section id
- NCT00869206-ae
- event group key
- EG001
- event group label
- Arm II (Zoledronic Acid Every 12 Weeks)
- serious affected
- 103
- serious at risk
- 868
- other affected
- 750
- other at risk
- 868
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00869206
- qol key
- qol-0001
- source section id
- NCT00869206-om-0001
- source outcome index
- 1
- instrument
- Brief Pain Inventory
- instrument basis
- matched 'brief pain inventory' in the study's own wording
- scale title
- Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire
- measure definition
- 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.
- time frame
- from baseline up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- 1766 patients completed treatment and were analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice