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NCT00329797 · ClinicalTrials.gov registry record · Phase 3
Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients With Locally Advanced Nonmetastatic Prostate Cancer Undergoing Radiation Therapy and Hormone Therapy
A Phase 3 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 109
- Enrollment target
NCT00329797: Completed Phase 3 study, sponsored by Radiation Therapy Oncology Group.
NCT00329797 is a Phase 3 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 109 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00329797, a Phase 3 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 109 participants
- Enrollment target
Study Summary
RATIONALE: Zoledronate may prevent bone loss in patients with prostate cancer undergoing radiation therapy and hormone therapy. It is not yet known whether zoledronate is more effective than calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with prostate cancer. PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with locally advanced nonmetastatic prostate cancer undergoing radiation therapy and hormone therapy.
Primary Outcome
The time of failure was measured from the date of randomization to the date of documented bone fractures, defined as any fracture of the bone. The three-year FABF rate will be estimated by the Kaplan-Meier method.
Interventions
- DIETARY_SUPPLEMENT Vitamin D
- RADIATION radiation therapy
- DIETARY_SUPPLEMENT Calcium
- DIETARY_SUPPLEMENT Zoledronic acid
- DRUG LHRH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2006-03 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
What the finished NCT00329797 record still lists
NCT00329797 is an interventional study that assigns participants to a tested intervention. The registered 109 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 (86% lower).
The record links to 0 conditions, and to 5 interventions - of which Vitamin D is the first listed.
NCT00329797 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00329797 about?
NCT00329797 is a clinical study titled "Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients With Locally Advanced Nonmetastatic Prostate Cancer Undergoing Radiation Therapy and Hormone Therapy". RATIONALE: Zoledronate may prevent bone loss in patients with prostate cancer undergoing radiation therapy and hormone therapy. It is not yet known whether zoledronate is more effective than calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with prostate cancer. ...
What is the current status of trial NCT00329797?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 109 participants. The study started on 2006-03. Estimated completion is 2014-11.
What interventions are being tested in trial NCT00329797?
The interventions under investigation include: Vitamin D (DIETARY_SUPPLEMENT), radiation therapy (RADIATION), Calcium (DIETARY_SUPPLEMENT), Zoledronic acid (DIETARY_SUPPLEMENT), LHRH (DRUG).
Who is sponsoring clinical trial NCT00329797?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00329797's enrollment target sits among peer trials
109 1664th of 2000 higher than 337 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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