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COMPLETED Phase 3

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

NCT00145327 · View on ClinicalTrials.gov ↗

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

60 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00145327

The ClinicalTrials.gov registry entry for NCT00145327 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,456 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 60 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00145327 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00145327?

The interventions under investigation include: Placebo (DRUG), Zoledronic Acid (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00145327?

This trial is sponsored by Novartis, which has 60 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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