Cortical Bone ThicknessNCT02995798
The Characteristics of Regional Bone Quality in the Cervical Vertebrae Considering BMD
An observational study of Cortical Bone Thickness, run by Gangneung Asan Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cortical Bone Thickness
- What is being tested?
- Cortical Bone thickness and Hounsfield unit (HU) numbers
- How many people
- 99 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2009to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- Patients who underwent the cervical CT and BMD simultaneously (the gap of both studies was within 6 months)
Who cannot join
- Who had any destructive pathology or severe spondylosis in the cervical pedicle and the cervical lateral mass.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cortical Bone Thickness
- Being tested
- Cortical Bone thickness and Hounsfield unit (HU) numbers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cortical Bone thickness and Hounsfield unit (HU) numbersOther
Cortical Bone thickness and Hounsfield unit (HU) numbers considering BMD
| Study group | Role | What they receive |
|---|---|---|
| Group A | T-score ≥-1 Receives: Other: Cortical Bone thickness and Hounsfield unit (HU) numbers | |
| Group B | -2.5<T-score<-1.0 Receives: Other: Cortical Bone thickness and Hounsfield unit (HU) numbers | |
| Group C | T-score≤-2.5 Receives: Other: Cortical Bone thickness and Hounsfield unit (HU) numbers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical bone Thickness
Measured: two weeks
HU number
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startApr 2009
- Primary completionDec 2014
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cortical Bone ThicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangneung Asan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Catholic University of Korea
- Responsible party
- Principal investigator, Moon-Kyu Kim, MD, Ph.D, Gangneung Asan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995798
- Sponsor's protocol ID
- Anatomy C-Spine
- Status last verified
- Dec 2016
- First submitted
- 9 Dec 2016
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Characteristics of Regional Bone Quality in the Cervical Vertebrae Considering BMD
- ClinicalTrials.gov ID
- NCT02995798
- Acronym / sponsor ID
- Anatomy C-Spine
- Conditions
- Cortical Bone Thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Gangneung Asan HospitalUniversity, hospital or other
- Collaborators
- The Catholic University of Korea
- Study start
- Apr 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Cortical Bone thickness and Hounsfield unit (HU) numbersT-score ≥-1 |
| Group B | – | Other: Cortical Bone thickness and Hounsfield unit (HU) numbers-2.5<T-score<-1.0 |
| Group C | – | Other: Cortical Bone thickness and Hounsfield unit (HU) numbersT-score≤-2.5 |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- Patients who underwent the cervical CT and BMD simultaneously (the gap of both studies was within 6 months)
Key exclusion criteria (1 listed)
- Who had any destructive pathology or severe spondylosis in the cervical pedicle and the cervical lateral mass.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cortical Bone thickness and Hounsfield unit (HU) numbersCortical Bone thickness and Hounsfield unit (HU) numbers considering BMD | Other | Group A, Group B, Group C |
Primary outcome
Cortical bone Thickness
Time frame: two weeks
HU number
Time frame: two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Cortical Bone Thickness
RecruitingObservational study
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Hemiparesis After Stroke, Dual Energy X-ray Absorptiometry
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cortical Bone Thickness, run by Gangneung Asan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical bone Thickness (time frame: two weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.