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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 is a Phase 4 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 14 participants.
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.
Interventions
- DRUG Saline
- DRUG exenatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2011-02 |
| Est. Completion | 2015-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01381926
The ClinicalTrials.gov registry entry for NCT01381926 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT01381926 reports 0 study locations.
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.
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