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NCT00129142 · ClinicalTrials.gov registry record · Phase 3

Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy

A Phase 3 study of Prostate Cancer and Osteoporosis, sponsored by GTx.

Completed
Registry status
Phase 3
Development phase
1,200
Enrollment target
20
Study locations

NCT00129142 is a Phase 3 study of Prostate Cancer and Osteoporosis that has completed, run by GTx. The registered enrollment target is 1,200 participants, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT00129142, a Phase 3 study of Prostate Cancer and Osteoporosis, has completed, sponsored by GTx.

COMPLETED
Registry status
Phase 3
Development phase
1,200 participants
Enrollment target
20
Study locations

Study Summary

Androgen deprivation therapy (ADT) treatment for prostate cancer decreases the natural hormone called testosterone. This type of therapy is very effective for the treatment of prostate cancer. However, one of the side effects is bone loss or thinning of the bones that can lead to osteoporosis and an increased risk of bone fractures (breaking of the bones). The purpose of the study is to determine whether or not the addition of toremifene citrate (the study drug) to therapy can prevent or decrease the number of bone fractures and to evaluate its impact on side effects associated with testosterone reduction therapy.

Interventions

  • DRUG Toremifene Citrate

Study Locations (20)

California

  • Advanced Urology Medical Center Clinical Trials - Anaheim
  • Urological Sciences Research Foudation - Culver City
  • Urological Associates of Central CA - Fresno
  • Center of Urologic Research - La Mesa
  • South Orange County Medical Research Center - Laguna Woods
  • Palo Alto VA - Palo Alto
  • San Bernadino Urological Associates - San Bernadino
  • Urological Physicians of San Diego - San Diego
  • Veterans Medical Research Foundation - San Diego
  • Pacific Clinical Research - Santa Monica
  • West Coast Clinical Research - Tarzana
  • Western Clinical Research, Inc. - Torrance

Connecticut

  • Urologic Center - New Haven
  • Urological Associates of Bridgeport - Trumball
  • Connecticut Clinical Research - Waterbury

Alabama

  • Urology Centers of Alabama - Homewood
  • Coastal Clinical Research - Mobile

Colorado

  • Urology Associates - Denver
  • Western Urological Research - Wheat Ridge

Arkansas

  • Arkansas Urology - Little Rock

Trial Details

FieldValue
Enrollment Target 1,200 participants
Start Date 2003-10
Est. Completion 2007-11
Phase Phase 3

Sponsor

GTx

15 total trials

What the Registry Record Tells You About NCT00129142

The ClinicalTrials.gov registry entry for NCT00129142 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% higher). The listed sponsor is GTx, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Toremifene Citrate is the first listed.

NCT00129142 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Connecticut, Alabama.

Frequently Asked Questions

What is clinical trial NCT00129142 about?

NCT00129142 is a clinical study titled "Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy". Androgen deprivation therapy (ADT) treatment for prostate cancer decreases the natural hormone called testosterone. This type of therapy is very effective for the treatment of prostate cancer. However, one of the side effects is bone loss or thinning of the bones that can lead to osteoporosis and an...

What is the current status of trial NCT00129142?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,200 participants. The study started on 2003-10. Estimated completion is 2007-11.

What conditions does trial NCT00129142 study?

This clinical trial studies the following conditions: Prostate Cancer, Osteoporosis, Fractures.

What interventions are being tested in trial NCT00129142?

The interventions under investigation include: Toremifene Citrate (DRUG).

Who is sponsoring clinical trial NCT00129142?

This trial is sponsored by GTx, which has 15 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00129142 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.