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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

All patients that were eligible and completed treatment were analyzed.

→

secondary · POSTED

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.

1766 patients completed treatment and were analyzed.

→

secondary · POSTED

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.

1766 patients completed treatment and were analyzed.

→

secondary · POSTED

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.

1766 patients completed treatment and were analyzed.

→

secondary · POSTED

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.

1689 patients completed treatment and were analyzed.

→

secondary · POSTED

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.

1766 patients were treated and analyzed.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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-gemcitabine-18a7d9a0
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

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-breast-cancer-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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-gemcitabine-18a7d9a0
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