Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases

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

Time to first skeletal related event (SRE) was defined as the time from randomization to first skeletal event. Skeletal events are defined as radiation to bone, clinical fracture, surgery to bone and spinal cord compression and death due to prostate cancer. The median with 95% CI was estimated using the Kaplan Meier method.

Source null

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secondary · POSTED

Overall survival (OS) was defined as the time from randomization to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.

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secondary · POSTED

Progression Free Survival (PFS) was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as one or more of the following: new bone metastases, biochemical progression of PSA, treatment with radiation therapy while on treatment.

Source null

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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

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-prostate-cancer-pluvicto-59550568
nct id: NCT00079001
trial label: Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
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: 3
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-pluvicto-59550568
nct id
NCT00079001
outcome key
om-0000
source section id
NCT00079001-om-0000
source outcome index
0
endpoint
Time to First Skeletal Related Event
endpoint definition
Time to first skeletal related event (SRE) was defined as the time from randomization to first skeletal event. Skeletal events are defined as radiation to bone, clinical fracture, surgery to bone and spinal cord compression and death due to prostate cancer. The median with 95% CI was estimated using the Kaplan Meier method.
time origin
Up to 10 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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-prostate-cancer-pluvicto-59550568
nct id
NCT00079001
outcome key
om-0001
source section id
NCT00079001-om-0001
source outcome index
1
endpoint
Overall Survival
endpoint definition
Overall survival (OS) was defined as the time from randomization to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.
time origin
Up to 10 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-prostate-cancer-pluvicto-59550568
nct id
NCT00079001
outcome key
om-0002
source section id
NCT00079001-om-0002
source outcome index
2
endpoint
Progression-free Survival
endpoint definition
Progression Free Survival (PFS) was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as one or more of the following: new bone metastases, biochemical progression of PSA, treatment with radiation therapy while on treatment.
time origin
Up to 10 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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-prostate-cancer-pluvicto-59550568
nct id
NCT00079001
outcome key
om-0000
arm key
OG000
arm label
Zoledronic Acid + Androgen Deprivation Therapy
regimen
4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
analyzed count
323
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00079001-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-pluvicto-59550568
nct id
NCT00079001
outcome key
om-0000
arm key
OG001
arm label
Placebo + Androgen Deprivation Therapy
regimen
Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
analyzed count
322
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00079001-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-pluvicto-59550568
nct id
NCT00079001
outcome key
om-0001
arm key
OG000
arm label
Zoledronic Acid + Androgen Deprivation Therapy
regimen
4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
analyzed count
323
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00079001-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-pluvicto-59550568
nct id
NCT00079001
outcome key
om-0001
arm key
OG001
arm label
Placebo + Androgen Deprivation Therapy
regimen
Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
analyzed count
322
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00079001-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-pluvicto-59550568
nct id
NCT00079001
outcome key
om-0002
arm key
OG000
arm label
Zoledronic Acid + Androgen Deprivation Therapy
regimen
4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
analyzed count
323
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00079001-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-pluvicto-59550568
nct id
NCT00079001
outcome key
om-0002
arm key
OG001
arm label
Placebo + Androgen Deprivation Therapy
regimen
Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
analyzed count
322
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00079001-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-pluvicto-59550568
nct id
NCT00079001
harm key
EG000
source section id
NCT00079001-ae
event group key
EG000
event group label
Zoledronic Acid + Androgen Deprivation Therapy
serious affected
60
serious at risk
310
other affected
269
other at risk
310
frequency threshold
0
collection period
Source null
event definition
All patients that reported adverse events were used to summarize the adverse events, data is available on 618 participants. Participants that were not assessed for adverse events were not included in the adverse event table.
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-prostate-cancer-pluvicto-59550568
nct id
NCT00079001
harm key
EG001
source section id
NCT00079001-ae
event group key
EG001
event group label
Placebo + Androgen Deprivation Therapy
serious affected
61
serious at risk
308
other affected
266
other at risk
308
frequency threshold
0
collection period
Source null
event definition
All patients that reported adverse events were used to summarize the adverse events, data is available on 618 participants. Participants that were not assessed for adverse events were not included in the adverse event table.
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

setting source links

Preserved source evidence · Not medical advice