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NCT01381926 · ClinicalTrials.gov registry record · Phase 4
Changes in Bone Turnover With Exposure to a GLP-1 Receptor Agonist
A Phase 4 study, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT01381926: Clinical Trial Phase 4 study, sponsored by University of Alabama at Birmingham.
NCT01381926 is a Phase 4 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01381926, a Phase 4 study, was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to determine changes in bone turnover markers and calcitonin following the initiation of exenatide compared to placebo in postmenopausal women wtih type 2 diabetes. Hypothesis 1a: Bone resorption (measured by osteocalcin and bone-specific alkaline phosphatase) will be lower and bone formation (measured by type I collagen crosslinked aminoterminal peptide in urine (Urine NTX)) will be higher when subjects are treated with exenatide compared to when subjects are treated with placebo. Hypothesis 1b: Calcitonin levels will not vary significantly between periods of treatment with exenatide vs. placebo.
Primary Outcome
Bone reabsorption by bone-specific alkaline phosphatase (BAP) was assessed. Distribution of the Difference between EX/PBO Low/High Dose and Baseline Levels were calculated.
Interventions
- DRUG Saline
- DRUG exenatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2011-02 |
| Est. Completion | 2015-08 |
| Phase | Phase 4 |
Why NCT01381926 stopped before completion
NCT01381926 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT01381926 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01381926 about?
NCT01381926 is a clinical study titled "Changes in Bone Turnover With Exposure to a GLP-1 Receptor Agonist". The purpose of this study is to determine changes in bone turnover markers and calcitonin following the initiation of exenatide compared to placebo in postmenopausal women wtih type 2 diabetes. Hypothesis 1a: Bone resorption (measured by osteocalcin and bone-specific alkaline phosphatase) will be l...
What is the current status of trial NCT01381926?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2011-02. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01381926?
The interventions under investigation include: Saline (DRUG), exenatide (DRUG).
Who is sponsoring clinical trial NCT01381926?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01381926's enrollment target sits among peer trials
14 1901st of 2000 higher than 91 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
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