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NCT00577837 · ClinicalTrials.gov registry record · Phase 2

Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD

A Phase 2 study of Postmenopausal, sponsored by Warner Chilcott.

Completed
Registry status
Phase 2
Development phase
370
Enrollment target
14
Study locations

NCT00577837: Completed Phase 2 study of Postmenopausal, sponsored by Warner Chilcott.

NCT00577837 is a Phase 2 study of Postmenopausal that has completed, run by Warner Chilcott. The registered enrollment target is 370 participants, above the 100-participant average among 9 other Postmenopausal trials with a reported enrollment target (270% higher). The trial reports 14 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00577837, a Phase 2 study of Postmenopausal, has completed, sponsored by Warner Chilcott.

COMPLETED
Registry status
Phase 2
Development phase
370 participants
Enrollment target
14
Study locations

Study Summary

A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with Low Bone Mineral Density.

Conditions Studied

Interventions

  • DRUG risedronate
  • DRUG experimental

Study Locations (14)

Other

  • Research Facility - Zagreb
  • Research Facility - Amsterdam
  • Research Facility - Leiden
  • Research Facility - Bialystok
  • Research Site - Lublin
  • Research Site - Warsaw
  • Research Site - Wroclaw

Florida

  • Research Site - Daytona Beach
  • Research Site - Gainesville

Quebec

  • Research Facility - Montreal
  • Research Facility - Sainte-Foy

Kansas

  • Research Site - Shawnee Mission

Texas

  • Research Site - San Antonio

Ontario

  • Research Site - Hamilton

Trial Details

FieldValue
Enrollment Target 370 participants
Start Date 2004-04
Est. Completion 2005-06
Phase Phase 2
Warner Chilcott

53 total trials

What the finished NCT00577837 record still lists

NCT00577837 is an interventional study that assigns participants to a tested intervention. The registered 370 participants enrollment target is mid-sized for trials with a published cap, above the 100-participant average among 9 other Postmenopausal trials with a reported enrollment target (270% higher).

The record links to 1 condition, with Postmenopausal appearing as the primary indexed condition, and to 2 interventions - of which risedronate is the first listed.

NCT00577837 lists 14 locations in 6 states (Other, Florida, Quebec).

Frequently Asked Questions

What is clinical trial NCT00577837 about?

NCT00577837 is a clinical study titled "Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD". A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with Low Bone Mineral Density.

What is the current status of trial NCT00577837?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 370 participants. The study started on 2004-04. Estimated completion is 2005-06.

What conditions does trial NCT00577837 study?

This clinical trial studies the following conditions: Postmenopausal.

What interventions are being tested in trial NCT00577837?

The interventions under investigation include: risedronate (DRUG), experimental (DRUG).

Who is sponsoring clinical trial NCT00577837?

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

Where is trial NCT00577837 being conducted?

This trial has 14 study locations across Florida, Kansas, Texas, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Postmenopausal

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00577837's enrollment target sits among peer trials

370 1st of 9 higher than 9 of 9 other Postmenopausal trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Postmenopausal 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 NCT00577837, the US trial registry maintained by the National Library of Medicine. NCT00577837 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.