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NCT00216060 · ClinicalTrials.gov registry record · Phase 3
Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy
A Phase 3 study, sponsored by Christopher Sweeney, MBBS.
- Terminated
- Registry status
- Phase 3
- Development phase
- 63
- Enrollment target
NCT00216060: Clinical Trial Phase 3 study, sponsored by Christopher Sweeney, MBBS.
NCT00216060 is a Phase 3 study that was terminated before completion, run by Christopher Sweeney, MBBS. The registered enrollment target is 63 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00216060, a Phase 3 study, was terminated before completion, sponsored by Christopher Sweeney, MBBS.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 63 participants
- Enrollment target
Study Summary
Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent than pamidronate and 72 times more potent than clodronate. Four randomized, double-blind trials have been carried out in patients with postmenopausal osteoporosis. In 2 of these studies, vertebral fracture incidence was reduced by a daily dose of 5 mg risedronate by up to 65% and 49% relative to placebo after 1 and 3 years, respectively. In these trials, risedronate improved lumbar spine, femoral neck, and femoral trochanter bone mineral density (BMD) at 6 months. In addition, preclinical studies have shown that risedronate is more potent than pamidronate and clodronate in inhibiting adhesion of prostate cancer cells to bone and preventing tumor cell invasion. The incidence of osteoporosis in prostate cancer patients has been well established; therefore, it is advantageous to assess the efficacy of oral bisphosphonate therapy.
Primary Outcome
Number of participants experiencing a SRE(skeletal-related event) or death occurred, cumulative from each arm ( a daily oral dose of 30 mg risedronate, or placebo)
Interventions
- DRUG Placebo
- DRUG Risedronate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2003-10 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
Why NCT00216060 stopped before completion
NCT00216060 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00216060 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00216060 about?
NCT00216060 is a clinical study titled "Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy". Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent than pamidronate and 72 times more potent than clodronate. Four randomized, double-blind trials have been carried out in patients with postmenopausal osteoporosis. In 2 of these studies, vertebral fracture in...
What is the current status of trial NCT00216060?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 63 participants. The study started on 2003-10. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00216060?
The interventions under investigation include: Placebo (DRUG), Risedronate (DRUG).
Who is sponsoring clinical trial NCT00216060?
This trial is sponsored by Christopher Sweeney, MBBS, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00216060's enrollment target sits among peer trials
63 1800th of 2000 higher than 199 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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