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NCT00035997 · ClinicalTrials.gov registry record · Phase 4
Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 261
- Enrollment target
NCT00035997: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT00035997 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 261 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00035997, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 261 participants
- Enrollment target
Study Summary
The purpose of this trial with Zometa is to investigate the effect ZOMETA 4 mg (zoledronic acid for injection in 100mg solution ) has in preventing associated bone loss in prostate cancer patients with bone metastasis when administered in conjunction with hormonal cancer therapy. This trial will seek to determine the effect of ZOMETA in stabilizing and increasing bone mineral density in these patients. This prospective, open-label, single arm, multicenter study will enroll approximately 200 prostate cancer patients with a history of at least one documented bone lesion documented by bone scan or radiograph. Patients must already be receiving hormone therapy and meet the following additional criteria: * 18 years of age or older * Histologically confirmed diagnoses of prostate cancer * Confirmed objective evidence of metastatic bone disease as evidenced by bone scan or radiograph * Received or will receive hormonal treatment also know as androgen deprivation therapy with an LHRH agonist or other hormonal treatments Throughout the course of this 12-month trial, patients will be identified based on the duration of established hormonal treatment at the time of enrollment. Each patients duration of participation will be up to 56 weeks including a 4 week screening, 48 week treatment and a 4 week follow up.
Interventions
- DRUG Zometa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2002-04 |
| Est. Completion | 2004-01 |
| Phase | Phase 4 |
What the finished NCT00035997 record still lists
NCT00035997 is an interventional study that assigns participants to a tested intervention. The registered 261 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Zometa is the first listed.
NCT00035997 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00035997 about?
NCT00035997 is a clinical study titled "Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis". The purpose of this trial with Zometa is to investigate the effect ZOMETA 4 mg (zoledronic acid for injection in 100mg solution ) has in preventing associated bone loss in prostate cancer patients with bone metastasis when administered in conjunction with hormonal cancer therapy. This trial will see...
What is the current status of trial NCT00035997?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 261 participants. The study started on 2002-04. Estimated completion is 2004-01.
What interventions are being tested in trial NCT00035997?
The interventions under investigation include: Zometa (DRUG).
Who is sponsoring clinical trial NCT00035997?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00035997's enrollment target sits among peer trials
261 326th of 2000 higher than 1,675 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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