Study of Zoledronic Acid for Patients With Hormone-sensitive Bone Metastases From Prostate Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00242567

First received: October 19, 2005

Last updated: March 18, 2013

Last verified: March 2013

History of Changes

Results First Received: January 29, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Prostate Cancer
Interventions:	Drug: Zoledronic Acid Drug: Androgen Deprivation Therapy (ADT)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Early Group	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
Delayed Group	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.

Participant Flow: Overall Study

	Early Group	Delayed Group
STARTED	259	263
Received at Least 1 Dose of Study Drug	259	72
Never Received Study Drug	0	191
COMPLETED	93	123
NOT COMPLETED	166	140
Adverse Event	70	43
Disease Progression	17	22
Symptomatic deterioration	9	3
Lack of Efficacy	2	2
Lost to Follow-up	9	18
Withdrawal by Subject	33	28
Protocol Violation	12	12
Use of an inhibitor of bone resorption	0	2
Unknown	14	10

Baseline Characteristics

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Reporting Groups

	Description
Early Group	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
Delayed Group	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
Total	Total of all reporting groups

Baseline Measures

	Early Group	Delayed Group	Total
Number of Participants [units: participants]	259	263	522
Age [units: years] Mean ± Standard Deviation	69.4 ± 8.48	70.2 ± 8.26	69.8 ± 8.37
Gender [units: participants]
Female	0	0	0
Male	259	263	522

Outcome Measures

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1. Primary:

Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer [ Time Frame: 18 months ]

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2. Secondary:

Overall Survival at 18 Months and 3 Years [ Time Frame: month 18, year 3 ]

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3. Secondary:

Time to Occurrence of SRE or Death [ Time Frame: 18 Months ]

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4. Secondary:

Skeletal-related Event(SRE)-Free Survival [ Time Frame: 36 months ]

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5. Secondary:

Multiple Event Analysis of Skeletal Related Events [ Time Frame: Year 3 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:

Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00242567 History of Changes
Other Study ID Numbers:	CZOL446E2432
Study First Received:	October 19, 2005
Results First Received:	January 29, 2013
Last Updated:	March 18, 2013
Health Authority:	Australia: National Health and Medical Research Council Brazil: Ministry of Health China: Ministry of Health Korea: Food and Drug Administration Kuwait: Joint Committee for the Protection of Human Subjects in Research Lebanon: Ministry of Public Health New Zealand: Ministry of Health Saudi Arabia: Ministry of Health Taiwan : Food and Drug Administration Thailand: Food and Drug Administration

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