NCT02995798

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

5.7 years

First QC Date

December 9, 2016

Last Update Submit

December 14, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Cortical bone Thickness

    two weeks

  • HU number

    two weeks

Study Arms (3)

Group A

T-score ≥-1

Other: Cortical Bone thickness and Hounsfield unit (HU) numbers

Group B

-2.5\<T-score\<-1.0

Other: Cortical Bone thickness and Hounsfield unit (HU) numbers

Group C

T-score≤-2.5

Other: Cortical Bone thickness and Hounsfield unit (HU) numbers

Interventions

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

Group AGroup BGroup C

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • Patients who underwent the cervical CT and BMD simultaneously (the gap of both studies was within 6 months)

You may not qualify if:

  • Who had any destructive pathology or severe spondylosis in the cervical pedicle and the cervical lateral mass.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moon-Kyu Kim

Gangneung, Kangwondo, 25440, South Korea

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 9, 2016

First Posted

December 16, 2016

Study Start

April 1, 2009

Primary Completion

December 1, 2014

Study Completion

August 1, 2016

Last Updated

December 16, 2016

Record last verified: 2016-12

Locations