NCT00079001 · OUTCOME

Time to First Skeletal Related Event

Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases · Source last updated 2020-05-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: Up to 10 years

What was measured

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.

Groups in this outcome

Zoledronic Acid + Androgen Deprivation Therapy

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).

Placebo + Androgen Deprivation Therapy

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Zoledronic Acid + Androgen Deprivation Therapy	323
Placebo + Androgen Deprivation Therapy	322

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Zoledronic Acid + Androgen Deprivation Therapy	31.9	Not reported	24.2	40.3	Not reported
Placebo + Androgen Deprivation Therapy	28.8	Not reported	25.3	37.2	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.174
estimate Comment
Patients randomly assigned to zoledronic acid were compared with patients assigned to placebo
group Description
The null hypothesis was that the hazard ratio is greater than or equal to 1.0 versus the alternative hypothesis that the hazard ratio is less than 0.77. With a target of 470 SREs, log-rank statistic had 88% power to detect a 23% decrease in hazard of SRE (equivalent to an increase in median time to SRE from 30 months to 39 months), assuming a one-sided type I error rate of .05.
group Ids
OG000
OG001
non Inferiority Comment
Superiority and futility analysis were conducted for time to first SRE. Lan-Demets analog of the Emerson-Fleming sequential boundary was used to maintain overall significance level of α = .05 while conducting interim analyses on time to first SRE.
non Inferiority Type
NON_INFERIORITY_OR_EQUIVALENCE_LEGACY
p Value
0.385
p Value Comment
Because of early termination, conditional power was performed under the alternative hypothesis. This is the probability that zoledronic acid is superior to placebo, given time to first SRE data at interim analysis under alternative hypothesis.
param Type
Hazard Ratio (HR)
param Value
0.97
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.174
estimate Comment
Patients randomly assigned to zoledronic acid were compared with patients assigned to placebo
group Description
The null hypothesis was that the hazard ratio is greater than or equal to 1.0 versus the alternative hypothesis that the hazard ratio is less than 0.77. With a target of 470 SREs, log-rank statistic had 88% power to detect a 23% decrease in hazard of SRE (equivalent to an increase in median time to SRE from 30 months to 39 months), assuming a one-sided type I error rate of .05.
group Ids
OG000
OG001
non Inferiority Comment
Superiority and futility analysis were conducted for time to first SRE. Lan-Demets analog of the Emerson-Fleming sequential boundary was used to maintain overall significance level of α = .05 while conducting interim analyses on time to first SRE.
non Inferiority Type
NON_INFERIORITY_OR_EQUIVALENCE_LEGACY
p Value
0.385
p Value Comment
Because of early termination, conditional power was performed under the alternative hypothesis. This is the probability that zoledronic acid is superior to placebo, given time to first SRE data at interim analysis under alternative hypothesis.
param Type
Hazard Ratio (HR)
param Value
0.97
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
24.2
upper Limit
40.3
value
31.9
group Id
OG001
lower Limit
25.3
upper Limit
37.2
value
28.8

denoms

counts
group Id
OG000
value
323
group Id
OG001
value
322
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
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).
id
OG000
title
Zoledronic Acid + Androgen Deprivation Therapy
description
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.
id
OG001
title
Placebo + Androgen Deprivation Therapy

param Type

MEDIAN

reporting Status

POSTED

time Frame

Up to 10 years

title

Time to First Skeletal Related Event

type

PRIMARY

unit Of Measure

months

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Preserved source evidence · Not medical advice