Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00489424 · ClinicalTrials.gov registry record · Phase 4
Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an Intravenous (i.v.) Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone Mass
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 793
- Enrollment target
NCT00489424: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT00489424 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 793 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (53% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00489424, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 793 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy of acetaminophen or fluvastatin in reducing the rate of occurrence and the severity of post dose symptoms that may occur during the 3 day period following a zoledronic acid infusion in post menopausal women with low bone mass.
Primary Outcome
Clinically significant increase in oral body temperature or used rescue medication ibuprofen \>= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. A clinically significant increase in body temperature was defined as an increase of at least 1 degree Celsius from baseline and a mean oral body temperature reading of at least 38.5 degrees Celsius occurring at least once during the 3-day treatment period.
Interventions
- DRUG Placebo
- DRUG Acetaminophen
- DRUG Fluvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 793 participants |
| Start Date | 2007-06 |
| Est. Completion | 2007-12 |
| Phase | Phase 4 |
What the finished NCT00489424 record still lists
NCT00489424 is an interventional study that assigns participants to a tested intervention. The registered 793 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (53% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00489424 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00489424 about?
NCT00489424 is a clinical study titled "Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an Intravenous (i.v.) Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone Mass". This study will evaluate the efficacy of acetaminophen or fluvastatin in reducing the rate of occurrence and the severity of post dose symptoms that may occur during the 3 day period following a zoledronic acid infusion in post menopausal women with low bone mass.
What is the current status of trial NCT00489424?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 793 participants. The study started on 2007-06. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00489424?
The interventions under investigation include: Placebo (DRUG), Acetaminophen (DRUG), Fluvastatin (DRUG).
Who is sponsoring clinical trial NCT00489424?
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 NCT00489424's enrollment target sits among peer trials
793 101st of 2000 higher than 1,900 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03424005 · 792 participants · Phase 1
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
- NCT05866081 · 792 participants · NA
Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
- NCT06722352 · 792 participants · NA
Palliative Care Education in Assisted Living for Dementia Care Providers (PCEAL-DCP)
- NCT06208150 · 795 participants · Phase 3
A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia