MedDataX Logo

The Characteristics of Regional Bone Quality in the Cervical Vertebrae Considering BMD

NCT ID: NCT02995798

Last Updated: 2016-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cortical Bone Thickness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

T-score ≥-1

Cortical Bone thickness and Hounsfield unit (HU) numbers

Intervention Type OTHER

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

Intervention Type OTHER

Cortical Bone thickness and Hounsfield unit (HU) numbers considering BMD

Group C

T-score≤-2.5

Cortical Bone thickness and Hounsfield unit (HU) numbers

Intervention Type OTHER

Cortical Bone thickness and Hounsfield unit (HU) numbers considering BMD

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cortical Bone thickness and Hounsfield unit (HU) numbers

Cortical Bone thickness and Hounsfield unit (HU) numbers considering BMD

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Catholic University of Korea

OTHER

Sponsor Role collaborator

Gangneung Asan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Moon-Kyu Kim, MD, Ph.D

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Moon-Kyu Kim

Gangneung, Kangwondo, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Anatomy C-Spine

Identifier Type: -

Identifier Source: org_study_id