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NCT00541658 · ClinicalTrials.gov registry record · Phase 3

A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis

A Phase 3 study of Postmenopausal Osteoporosis, sponsored by Warner Chilcott.

Completed
Registry status
Phase 3
Development phase
923
Enrollment target
20
Study locations

NCT00541658 is a Phase 3 study of Postmenopausal Osteoporosis that has completed, run by Warner Chilcott. The registered enrollment target is 923 participants, above the 509-participant average among 12 other Postmenopausal Osteoporosis trials with a reported enrollment target (81% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT00541658, a Phase 3 study of Postmenopausal Osteoporosis, has completed, sponsored by Warner Chilcott.

COMPLETED
Registry status
Phase 3
Development phase
923 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

Conditions Studied

Postmenopausal Osteoporosis

Interventions

  • DRUG risedronate

Study Locations (20)

California

  • Research Site - Oakland
  • Research Site - San Diego
  • Research Facility - Walnut Creek
  • Research Site - Walnut Creek

Florida

  • Research Site - Leesburg
  • Research Site - Melbourne
  • Research Site - South Miami

Illinois

  • Research Site - Champaign
  • Research Site - Chicago

Alabama

  • Research Site - Birmingham

Colorado

  • Research Site - Lakewood

Georgia

  • Research Site - Gainesville

Maryland

  • Research Site - Bethesda

Massachusetts

  • Research Site - Brockton

Trial Details

FieldValue
Enrollment Target 923 participants
Start Date 2007-10
Est. Completion 2010-04
Phase Phase 3

Sponsor

Warner Chilcott

53 total trials

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What the Registry Record Tells You About NCT00541658

The ClinicalTrials.gov registry entry for NCT00541658 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 923 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 509-participant average among 12 other Postmenopausal Osteoporosis trials with a reported enrollment target (81% higher). The listed sponsor is Warner Chilcott, which has 53 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Postmenopausal Osteoporosis appearing as the primary indexed condition, and to 1 intervention - of which risedronate is the first listed.

NCT00541658 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT00541658 about?

NCT00541658 is a clinical study titled "A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis". The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

What is the current status of trial NCT00541658?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 923 participants. The study started on 2007-10. Estimated completion is 2010-04.

What conditions does trial NCT00541658 study?

This clinical trial studies the following conditions: Postmenopausal Osteoporosis.

What interventions are being tested in trial NCT00541658?

The interventions under investigation include: risedronate (DRUG).

Who is sponsoring clinical trial NCT00541658?

This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00541658 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. 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.