NCT04403256

Brief Summary

Patients with spinal cord injury have a high prevalence of osteoporosis due to chronic skeletal unloading. Recently, various treatment drugs for osteoporosis have been developed. In particular, romosozumab, a sclerostin inhibitor, has been reported to have a high therapeutic effect as an inhibitor of bone resorption while promoting bone formation. However, there are a few research concerning sclerostin of spinal cord injuries patients. Therefore we want to analyze the change of sclerostin as well as factors indicating bone formation and absorption marker in spinal cord injury patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

1.6 years

First QC Date

March 25, 2020

Last Update Submit

August 30, 2021

Conditions

Spinal Cord InjuriesBone ResorptionOsteoporosis

Keywords

SclerostinosteoporosisSpinal cord injuryUnloading

Outcome Measures

Primary Outcomes (1)

  • Serum sclerostin level

    Serum sclerostin level in spinal cord injury patients

    1 year

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with spinal cord injury difficult to walk

You may qualify if:

  • spinal cord injury patients
  • Functional ambulatory category index of 3 or less

You may not qualify if:

  • history of using bone absorption medication within the effective period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeungnam University Hospital

Daegu, 42415, South Korea

Location

MeSH Terms

Conditions

Spinal Cord InjuriesBone ResorptionOsteoporosisSclerosteosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBone DiseasesMusculoskeletal DiseasesBone Diseases, MetabolicMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 25, 2020

First Posted

May 27, 2020

Study Start

February 5, 2020

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

August 31, 2021

Record last verified: 2021-08

Locations

KR(1)