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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: Completed Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT00079001 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 645 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Interventions
- OTHER placebo
- DIETARY_SUPPLEMENT Calcium supplement
- DRUG androgen deprivation therapy
- DRUG zoledronic acid
- DRUG GnRH agonist
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 645 participants |
| Start Date | 2004-01 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
What the finished NCT00079001 record still lists
NCT00079001 is an interventional study that assigns participants to a tested intervention. The registered 645 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT00079001 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00079001's enrollment target sits among peer trials
645 572nd of 2000 higher than 1,429 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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