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NCT00079001 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 3
Development phase
645
Enrollment target

NCT00079001 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 645 participants.

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The verdict

NCT00079001, a Phase 3 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 3
Development phase
645 participants
Enrollment target

Study Summary

RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases. PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases.

Interventions

  • OTHER placebo
  • DIETARY_SUPPLEMENT Calcium supplement
  • DRUG androgen deprivation therapy
  • DRUG zoledronic acid
  • DRUG GnRH agonist

Trial Details

FieldValue
Enrollment Target 645 participants
Start Date 2004-01
Est. Completion 2014-10
Phase Phase 3

What the Registry Record Tells You About NCT00079001

The ClinicalTrials.gov registry entry for NCT00079001 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 645 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.

NCT00079001 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00079001 about?

NCT00079001 is a clinical study titled "Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases". RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate ca...

What is the current status of trial NCT00079001?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 645 participants. The study started on 2004-01. Estimated completion is 2014-10.

What interventions are being tested in trial NCT00079001?

The interventions under investigation include: placebo (OTHER), Calcium supplement (DIETARY_SUPPLEMENT), androgen deprivation therapy (DRUG), zoledronic acid (DRUG), GnRH agonist (DRUG).

Who is sponsoring clinical trial NCT00079001?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.