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NCT00964119 · ClinicalTrials.gov registry record
Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population
A clinical trial, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- 15
- Enrollment target
NCT00964119: Clinical Trial study, sponsored by University of Wisconsin, Madison.
NCT00964119 is a clinical trial that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00964119 was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- 15 participants
- Enrollment target
Study Summary
This is a prospective study, that will follow participants over their course of treatment on Isotretinoin. All patients who are prescribed Isotretinoin for their acne treatment are registered in iPLEDGE. The iPLEDGE program involves a set of steps that the patient, physician and pharmacist must follow for the patient to take Isotretinoin. Patients will be asked if they are willing to participate in this research study to determine musculoskeletal changes in adolescents and young adults on systemic therapy using the highly sensitive magnetic resonance (MR) imaging modality. In addition to the MRI, participants will be asked if they are willing to give an extra sample of blood when their routine blood work is being done for iPLEDGE. This blood sample will be used to determine if there are any effects of isotretinoin on bone turnover markers.
Primary Outcome
Bone Marker measurements to assess skeletal toxicities: Change in Bone specific Alkaline Phosphatase: (BSAP) over 5 months of therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2008-07 |
| Est. Completion | 2013-08 |
Why NCT00964119 stopped before completion
NCT00964119 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 15 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00964119 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00964119 about?
NCT00964119 is a clinical study titled "Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population". This is a prospective study, that will follow participants over their course of treatment on Isotretinoin. All patients who are prescribed Isotretinoin for their acne treatment are registered in iPLEDGE. The iPLEDGE program involves a set of steps that the patient, physician and pharmacist must foll...
What is the current status of trial NCT00964119?
This trial is currently terminated. The enrollment target is 15 participants. The study started on 2008-07. Estimated completion is 2013-08.
Who is sponsoring clinical trial NCT00964119?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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