Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01642901 · ClinicalTrials.gov registry record · Phase 3
Zoledronic Acid in Acute Spinal Cord Injury
A Phase 3 study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 3
- Development phase
- 16
- Enrollment target
NCT01642901 is a Phase 3 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 16 participants.
The verdict
NCT01642901, a Phase 3 study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 16 participants
- Enrollment target
Study Summary
Maintenance of bone mass following spinal cord injury (SCI) is essential to fracture prevention and the associated morbidity of bed rest and further secondary complications. Intravenous (IV) zoledronic acid (ZA) is an FDA-approved drug that has been shown to be more effective than other agents in reducing bone mass resorption and leg fractures in post-menopausal women, but has not been studied in patients with acute SCI. This will be a randomized, double-blind, placebo-controlled trial of IV ZA to prevent bone loss early after SCI. Up to 48 subjects will be randomized to receive a one-time dose of 5 mg of IV ZA versus placebo within 21 days of an SCI.
Interventions
- DRUG Zoledronic acid
- DRUG normal saline 0.9%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-09 |
| Est. Completion | 2018-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01642901
The ClinicalTrials.gov registry entry for NCT01642901 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Zoledronic acid is the first listed.
NCT01642901 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01642901 about?
NCT01642901 is a clinical study titled "Zoledronic Acid in Acute Spinal Cord Injury". Maintenance of bone mass following spinal cord injury (SCI) is essential to fracture prevention and the associated morbidity of bed rest and further secondary complications. Intravenous (IV) zoledronic acid (ZA) is an FDA-approved drug that has been shown to be more effective than other agents in re...
What is the current status of trial NCT01642901?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 16 participants. The study started on 2012-09. Estimated completion is 2018-03.
What interventions are being tested in trial NCT01642901?
The interventions under investigation include: Zoledronic acid (DRUG), normal saline 0.9% (DRUG).
Who is sponsoring clinical trial NCT01642901?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.