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NCT00103740 · 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 of Paget's Disease of Bone, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 185
- Enrollment target
- 20
- Study locations
NCT00103740: Completed Phase 3 study of Paget's Disease of Bone, sponsored by Novartis Pharmaceuticals.
NCT00103740 is a Phase 3 study of Paget's Disease of Bone that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 185 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00103740, a Phase 3 study of Paget's Disease of Bone, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 185 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this core study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response. The extended observation period included participants of the core study who responded to treatment.
Primary Outcome
A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint to the normal range) or normalization of SAP at the end of six months.
Conditions Studied
Interventions
- DRUG Risedronate
- DRUG zoledronic acid
- DRUG placebo to zoledronic acid
- DRUG Placebo to risedronate
- DRUG Calcium and vitamin D supplements
Study Locations (20)
Other
- Novartis Investigative Site - Fitzroy
- Novartis Investigative Site - Kogarah
- Novartis Investigative site - Newcastle
- Novartis Investigative Site - Parkville
- Novartis Investigative site - St Leonards
- Novartis Investigative site - Brussels
- Novartis Investigative Site - Ghent
- Novartis Investigative Site - Montreal
- Novartis Investigative Site - Angers
- Novartis Investigative Site - Dreux
Arizona
- Novartis Investigative site - Tucson
Colorado
- Novartis Investigative Site - Colorado Springs
Indiana
- Novartis Investigative Site - Indianapolis
Louisiana
- Novartis Investigative Site - New Orleans
Massachusetts
- Novartis Investigative Site - Boston
New York
- Novartis Investigative Site - Syracuse
Ohio
- Novartis Investigative Site - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2002-04 |
| Est. Completion | 2011-04 |
| Phase | Phase 3 |
What the finished NCT00103740 record still lists
NCT00103740 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Paget's Disease of Bone appearing as the primary indexed condition, and to 5 interventions - of which Risedronate is the first listed.
NCT00103740 names 20 study sites across 11 states, led by Other, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT00103740 about?
NCT00103740 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 primary objective of this core study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response. The extended observation period included participants of the core study who responded to treatment.
What is the current status of trial NCT00103740?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 185 participants. The study started on 2002-04. Estimated completion is 2011-04.
What conditions does trial NCT00103740 study?
This clinical trial studies the following conditions: Paget's Disease of Bone.
What interventions are being tested in trial NCT00103740?
The interventions under investigation include: Risedronate (DRUG), zoledronic acid (DRUG), placebo to zoledronic acid (DRUG), Placebo to risedronate (DRUG), Calcium and vitamin D supplements (DRUG).
Who is sponsoring clinical trial NCT00103740?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00103740 being conducted?
This trial has 20 study locations across Arizona, Colorado, Indiana, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00103740's enrollment target sits among peer trials
185 1417th of 2000 higher than 583 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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