- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02995798
The Characteristics of Regional Bone Quality in the Cervical Vertebrae Considering BMD
December 14, 2016 updated by: Moon-Kyu Kim, MD, Ph.D, Gangneung Asan Hospital
Data of CT images and the femoral neck BMD were obtained from 99 patients who underwent the cervical CT and BMD simultaneously (the gap of both studies was within 6 months) from April 2009 to December 2014.
There were 52 females and 47 males.
The mean age was 63.7 year (female: 63.4 years, male: 64.1; range 32-86 years).
The patient was excluded who had any destructive pathology or severe spondylosis in the cervical pedicle and the cervical lateral mass.
Patients were divided into three groups according to femoral neck BMD (Group A, T-score ≥-1; Group B, -2.5<T-score<-1.0;
Group C, T-score≤-2.5).
Group A had normal BMD patients, Group B had lower normal patients including osteopenic patients and Group C presented osteoporotic patients.
The mean HU numbers of cortical bone area in the vertebral canal (cHU, the medial wall of the lateral mass), the posterior wall of transverse foramen (fHU), the medial (mHU), lateral wall (lHU) and trabecular area of pedicle (pHU) were measured on the axial CT images in clinical images.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
99
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kangwondo
-
Gangneung, Kangwondo, Korea, Republic of, 25440
- Moon-Kyu Kim
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Data of CT images and the femoral neck BMD were obtained from 99 patients who underwent the cervical CT and BMD simultaneously (the gap of both studies was within 6 months)
Description
Inclusion Criteria:
- Patients who underwent the cervical CT and BMD simultaneously (the gap of both studies was within 6 months)
Exclusion Criteria:
- Who had any destructive pathology or severe spondylosis in the cervical pedicle and the cervical lateral mass.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group A
T-score ≥-1
|
Cortical Bone thickness and Hounsfield unit (HU) numbers considering BMD
|
|
Group B
-2.5<T-score<-1.0
|
Cortical Bone thickness and Hounsfield unit (HU) numbers considering BMD
|
|
Group C
T-score≤-2.5
|
Cortical Bone thickness and Hounsfield unit (HU) numbers considering BMD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cortical bone Thickness
Time Frame: two weeks
|
two weeks
|
|
HU number
Time Frame: two weeks
|
two weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
December 9, 2016
First Submitted That Met QC Criteria
December 14, 2016
First Posted (Estimate)
December 16, 2016
Study Record Updates
Last Update Posted (Estimate)
December 16, 2016
Last Update Submitted That Met QC Criteria
December 14, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- Anatomy C-Spine
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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