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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 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 200 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00063609
The ClinicalTrials.gov registry entry for NCT00063609 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which zoledronic acid is the first listed.
NCT00063609 reports 0 study locations.
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.
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