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NCT00063609 · ClinicalTrials.gov registry record · Phase 4
The Effect of Zoledronic Acid on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 200
- Enrollment target
NCT00063609: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT00063609 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 200 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00063609, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 200 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the effect of an investigational drug used intravenously and placebo administered every three months for one year, on bone loss associated with initial androgen deprivation) in men with prostate cancer without metastasis. In order to participate in this trial male patients must be 18 years of age or older and have been diagnosed with prostate cancer without metastasis and within one year of starting their androgen deprivation therapy at the day of randomization onto this trial. In addition, patients who have undergone a recent orchiectomy (or"ke-ek'te-me) (removal of one or two testes) are eligible to participate. Patients who received any prior bisphosphonate therapy or prior treatment with systemic corticosteroids within in the past 12 months are not eligible to participate. Also patients who are receiving treatment for osteoporosis are not eligible to participate. Inclusion into this clinical trial with this investigational drug is based on the protocol entry criteria and evaluation from a participating trial investigator.
Interventions
- DRUG zoledronic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2003-04 |
| Est. Completion | 2005-04 |
| Phase | Phase 4 |
What the finished NCT00063609 record still lists
NCT00063609 is an interventional study that assigns participants to a tested intervention. The registered 200 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 (61% lower).
The record links to 0 conditions, and to 1 intervention - of which zoledronic acid is the first listed.
NCT00063609 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00063609 about?
NCT00063609 is a clinical study titled "The Effect of Zoledronic Acid on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy". The purpose of this study is to compare the effect of an investigational drug used intravenously and placebo administered every three months for one year, on bone loss associated with initial androgen deprivation) in men with prostate cancer without metastasis. In order to participate in this trial ...
What is the current status of trial NCT00063609?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2003-04. Estimated completion is 2005-04.
What interventions are being tested in trial NCT00063609?
The interventions under investigation include: zoledronic acid (DRUG).
Who is sponsoring clinical trial NCT00063609?
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 NCT00063609's enrollment target sits among peer trials
200 407th of 2000 higher than 1,556 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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