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NCT03029442 · ClinicalTrials.gov registry record · Phase 4
The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury
A Phase 4 study, sponsored by James J. Peters Veterans Affairs Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT03029442 is a Phase 4 study that was terminated before completion, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 5 participants.
The verdict
NCT03029442, a Phase 4 study, was terminated before completion, sponsored by James J. Peters Veterans Affairs Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the usefulness of a drug, denosumab, to prevent the loss of bone in participants legs due to SCI. This drug is FDA approved to treat osteoporosis in women after menopause who have an increased risk for fractures, to treat women receiving certain treatments for breast cancer who have an increased risk of fractures, and to treat bone loss in men receiving certain treatments for prostate cancer who have increased risk for fractures. This drug is considered experimental for the purpose of this study. Study participation will last for approximately 12 months (6 study visits total), visits will range from1-4.5 hours depending on the number of tests that need to be completed. The study is a double-blinded placebo trail in which the participant will be randomly assigned to on of two groups, Denosumab injections or placebo - inactive salt solution injections.
Interventions
- DRUG Denosumab (Prolia)
- OTHER Placebo (normal saline)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-04-01 |
| Est. Completion | 2022-10-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03029442
The ClinicalTrials.gov registry entry for NCT03029442 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James J. Peters Veterans Affairs Medical Center, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Denosumab (Prolia) is the first listed.
NCT03029442 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03029442 about?
NCT03029442 is a clinical study titled "The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury". The purpose of this study is to determine the usefulness of a drug, denosumab, to prevent the loss of bone in participants legs due to SCI. This drug is FDA approved to treat osteoporosis in women after menopause who have an increased risk for fractures, to treat women receiving certain treatments f...
What is the current status of trial NCT03029442?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2017-04-01. Estimated completion is 2022-10-06.
What interventions are being tested in trial NCT03029442?
The interventions under investigation include: Denosumab (Prolia) (DRUG), Placebo (normal saline) (OTHER).
Who is sponsoring clinical trial NCT03029442?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
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