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: Completed Phase 3 study, sponsored by Thomas Jefferson University.
NCT01642901 is a Phase 3 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 16 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percent change in areal bone mineral density (aBMD) assessed by dual energy X-ray absorptiometry (DXA) at 4 months compared to baseline. This will compare aBMD at the hip.
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 |
What the finished NCT01642901 record still lists
NCT01642901 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Zoledronic acid is the first listed.
NCT01642901 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01642901's enrollment target sits among peer trials
16 1974th of 2000 higher than 24 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
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
- NCT02422641 · 16 participants · Phase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
- NCT02851758 · 16 participants · NA
Transplantation of Autologously Derived Mitochondria Following Ischemia
- NCT03291028 · 16 participants
Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma
- NCT03425526 · 16 participants · Phase 1
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
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