The Construction of Bidirectional Column Study of Acute O... | NCT06586996

Studies
The Construction of Bidirectional Column Study of Acute Osteoporotic Vertebral Compression Fractures

NCT06586996

Sponsor

Peking University Third Hospital

Status

Unknown status

Last Update Posted

Sep 19, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Osteoporosis Fracture

Interventions

no intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Sep 4, 2024

First Submission Date that Met QC Criteria

Sep 4, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Our research group plans to establish a disease specific bidirectional cohort study on prognosis prediction of acute osteoporotic vertebral compression fracture based on imaging and clinical data, and to establish a comprehensive bioinformation database on OVCFs, including patient status, clinical data, laboratory examination, and imaging examination database

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
osteoporotic vertebral compression fractures			Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention	osteoporotic vertebral compression fractures

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VAS value	the visual analogue scale value of patient	2 weeks, 1 month, 2 months, 3months, 6 months and 12 months
vertebrae height	the height of the vertebrae according to the X rays	2 weeks, 1 month, 2 months, 3months, 6 months and 12 months
T value	the T value of the dual energy X-ray absorptiometry	6months and 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: all patients who suffer a acute osteoporosis vertebral compression fractures -

Exclusion Criteria: those who have endocrine disease which have impacts on the bone density

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

All the acute osteoporosis vertebral compression fracture patients who search for treatments in our hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospita	Recruiting	Beijing		100083	China

Condition Browse Module

MeSH Terms

ID	Term
D058866	Osteoporotic Fractures

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided