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NCT00668200 · ClinicalTrials.gov registry record · Phase 4
Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast®
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 81
- Enrollment target
NCT00668200: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT00668200 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 81 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00668200, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 81 participants
- Enrollment target
Study Summary
This study will evaluate the impact of investigator and patient education and educational materials to foster calcium and vitamin D supplementation to mitigate the potential for hypocalcemia post Reclast® administration in patients with Paget's disease of bone.
Primary Outcome
To be included in the analysis, patients were required to have a baseline serum calcium of at least 2.07 mmol/L and at least one serum calcium measurement 9-11 days post-infusion of zoledronic acid. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used. hypocalcemia was defined as treatment-emergent serum calcium \<2.07 mmol/L at 9-11 days after the s
Interventions
- DIETARY_SUPPLEMENT Vitamin D
- DIETARY_SUPPLEMENT Calcium
- DRUG Reclast (ZOL446, zoledronic acid)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2008-05 |
| Est. Completion | 2012-11 |
| Phase | Phase 4 |
What the finished NCT00668200 record still lists
NCT00668200 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 3 interventions - of which Vitamin D is the first listed.
NCT00668200 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00668200 about?
NCT00668200 is a clinical study titled "Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast®". This study will evaluate the impact of investigator and patient education and educational materials to foster calcium and vitamin D supplementation to mitigate the potential for hypocalcemia post Reclast® administration in patients with Paget's disease of bone.
What is the current status of trial NCT00668200?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 81 participants. The study started on 2008-05. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00668200?
The interventions under investigation include: Vitamin D (DIETARY_SUPPLEMENT), Calcium (DIETARY_SUPPLEMENT), Reclast (ZOL446, zoledronic acid) (DRUG).
Who is sponsoring clinical trial NCT00668200?
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 NCT00668200's enrollment target sits among peer trials
81 940th of 2000 higher than 1,055 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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