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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: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00051636 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 172 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Therapeutic response is defined as a reduction of at least 75% from baseline (Visit 1) in total serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase at the end of six months.
Interventions
- DRUG Risedronate
- DRUG Zoledronic Acid
- DIETARY_SUPPLEMENT Calcium and Vitamin D
- DRUG Placebo to Zoledronic Acid
- DRUG Placebo to Risedronate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2001-01 |
| Est. Completion | 2011-04 |
| Phase | Phase 3 |
What the finished NCT00051636 record still lists
NCT00051636 is an interventional study that assigns participants to a tested intervention. The registered 172 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 (78% lower).
The record links to 0 conditions, and to 5 interventions - of which Risedronate is the first listed.
NCT00051636 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00051636's enrollment target sits among peer trials
172 1448th of 2000 higher than 550 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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