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NCT00058188 · ClinicalTrials.gov registry record · Phase 3

Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation

A Phase 3 study, sponsored by Northwestern University.

Terminated
Registry status
Phase 3
Development phase
53
Enrollment target

NCT00058188: Clinical Trial Phase 3 study, sponsored by Northwestern University.

NCT00058188 is a Phase 3 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 53 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00058188, a Phase 3 study, was terminated before completion, sponsored by Northwestern University.

TERMINATED
Registry status
Phase 3
Development phase
53 participants
Enrollment target

Study Summary

RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss. PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term androgen deprivation therapy.

Primary Outcome

To assess bone density change as measured by dual-energy x-ray absorptiometry

Interventions

  • DRUG zoledronic acid
  • DRUG calcium gluconate
  • DIETARY_SUPPLEMENT cholecalciferol

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2003-03
Est. Completion 2008-11
Phase Phase 3
Northwestern University

1,209 total trials

Why NCT00058188 stopped before completion

NCT00058188 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 3 interventions - of which zoledronic acid is the first listed.

NCT00058188 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00058188 about?

NCT00058188 is a clinical study titled "Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation". RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss. PURPOSE: Randomized phase III trial to compare the effectiveness of zoledr...

What is the current status of trial NCT00058188?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 53 participants. The study started on 2003-03. Estimated completion is 2008-11.

What interventions are being tested in trial NCT00058188?

The interventions under investigation include: zoledronic acid (DRUG), calcium gluconate (DRUG), cholecalciferol (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00058188?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00058188's enrollment target sits among peer trials

53 1839th of 2000 higher than 160 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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Source: ClinicalTrials.gov NCT00058188, the US trial registry maintained by the National Library of Medicine. NCT00058188 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.