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NCT00145327 · ClinicalTrials.gov registry record · Phase 3

Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)

A Phase 3 study of Osteoporosis, sponsored by Novartis.

Completed
Registry status
Phase 3
Development phase
2,456
Enrollment target
20
Study locations

NCT00145327 is a Phase 3 study of Osteoporosis that has completed, run by Novartis. The registered enrollment target is 2,456 participants, above the 1,517-participant average among 84 other Osteoporosis trials with a reported enrollment target (62% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT00145327, a Phase 3 study of Osteoporosis, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 3
Development phase
2,456 participants
Enrollment target
20
Study locations

Study Summary

This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year core study ended. Baseline is the same as Year 3.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Zoledronic Acid

Study Locations (20)

California

  • Osteoporosis Medical Center - Beverly Hills
  • Osteoporosis Prevention Center - San Diego
  • Diablo Clinical Research, Inc - Walnut Creek

Florida

  • CRIA Research - Fort Lauderdale
  • Radiant Research - Stuart
  • Comprehensive Clinical Trials, LLC - West Palm Beach

Indiana

  • School of Medicine - Indianapolis
  • Medical Specialist Clinical Research Center - Munster

Arizona

  • Southern Arizona VA - Tucson

Arkansas

  • University of Arkansas for Medical Science - Little Rock

Colorado

  • Colorado Center for Bone Research - Lakewood

Georgia

  • United Osteoporosis Centers (UOC) - Gainesville

Illinois

  • Northwestern University Center for Clinical Research - Chicago

Trial Details

FieldValue
Enrollment Target 2,456 participants
Start Date 2005-05
Est. Completion 2009-11
Phase Phase 3

Sponsor

Novartis

265 total trials

What the Registry Record Tells You About NCT00145327

The ClinicalTrials.gov registry entry for NCT00145327 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,456 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,517-participant average among 84 other Osteoporosis trials with a reported enrollment target (62% higher). The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.

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

NCT00145327 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Florida, Indiana.

Frequently Asked Questions

What is clinical trial NCT00145327 about?

NCT00145327 is a clinical study titled "Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)". This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year core study ended. Baseline is...

What is the current status of trial NCT00145327?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,456 participants. The study started on 2005-05. Estimated completion is 2009-11.

What conditions does trial NCT00145327 study?

This clinical trial studies the following conditions: Osteoporosis.

What interventions are being tested in trial NCT00145327?

The interventions under investigation include: Placebo (DRUG), Zoledronic Acid (DRUG).

Who is sponsoring clinical trial NCT00145327?

This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00145327 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. 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.