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NCT00051636 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
172
Enrollment target

NCT00051636 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 172 participants.

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The verdict

NCT00051636, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
172 participants
Enrollment target

Study Summary

The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.) infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone. The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The extended observation period included participants of the core study who responded to treatment.

Interventions

  • DRUG Risedronate
  • DRUG Zoledronic Acid
  • DIETARY_SUPPLEMENT Calcium and Vitamin D
  • DRUG Placebo to Zoledronic Acid
  • DRUG Placebo to Risedronate

Trial Details

FieldValue
Enrollment Target 172 participants
Start Date 2001-01
Est. Completion 2011-04
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT00051636

The ClinicalTrials.gov registry entry for NCT00051636 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 172 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Risedronate is the first listed.

NCT00051636 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00051636 about?

NCT00051636 is a clinical study titled "Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period". The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.) infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone. The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The extended observation period incl...

What is the current status of trial NCT00051636?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 172 participants. The study started on 2001-01. Estimated completion is 2011-04.

What interventions are being tested in trial NCT00051636?

The interventions under investigation include: Risedronate (DRUG), Zoledronic Acid (DRUG), Calcium and Vitamin D (DIETARY_SUPPLEMENT), Placebo to Zoledronic Acid (DRUG), Placebo to Risedronate (DRUG).

Who is sponsoring clinical trial NCT00051636?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

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

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.