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NCT02025179 · ClinicalTrials.gov registry record · Phase 2
12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI)
A Phase 2 study of Spinal Cord Injury and Osteoporosis, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT02025179: Completed Phase 2 study of Spinal Cord Injury and Osteoporosis, sponsored by Northwestern University.
NCT02025179 is a Phase 2 study of Spinal Cord Injury and Osteoporosis that has completed, run by Northwestern University. The registered enrollment target is 25 participants, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02025179, a Phase 2 study of Spinal Cord Injury and Osteoporosis, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine if a second year of exposure to teriparatide in both subjects that received a year of teriparatide or teriparatide-placebo will result in a greater increase in bone mass density (BMD) compared to that seen in a single year's treatment. This study will also investigate 1) if a second year of teriparatide therapy will increase bone strength in people with chronic spinal cord injury (SCI) who previously received a year of teriparatide or teriparatide-placebo, 2) the number of participants with adverse events from teriparatide, and 3) the effects of teriparatide on serum markers of bone metabolism.
Primary Outcome
The mean percent change in BMD of the total hip after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24
Conditions Studied
Interventions
- DEVICE Vibration
- DRUG Teriparatide
Study Locations (1)
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-08-14 |
| Phase | Phase 2 |
What the finished NCT02025179 record still lists
NCT02025179 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (71% lower).
The record links to 3 conditions, with Spinal Cord Injury appearing as the primary indexed condition, and to 2 interventions - of which Vibration is the first listed.
NCT02025179 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT02025179 about?
NCT02025179 is a clinical study titled "12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI)". The purpose of this study is to determine if a second year of exposure to teriparatide in both subjects that received a year of teriparatide or teriparatide-placebo will result in a greater increase in bone mass density (BMD) compared to that seen in a single year's treatment. This study will also ...
What is the current status of trial NCT02025179?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2013-01. Estimated completion is 2015-08-14.
What conditions does trial NCT02025179 study?
This clinical trial studies the following conditions: Spinal Cord Injury, Osteoporosis, Bone Loss.
What interventions are being tested in trial NCT02025179?
The interventions under investigation include: Vibration (DEVICE), Teriparatide (DRUG).
Who is sponsoring clinical trial NCT02025179?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02025179 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Spinal Cord Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02025179's enrollment target sits among peer trials
25 50th of 99 higher than 50 of 99 other Spinal Cord Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injury 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.
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