NCT02403726

Brief Summary

The purposes of this study were to analyse demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
694

participants targeted

Target at P75+ for all trials

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

January 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

4.2 years

First QC Date

March 20, 2015

Last Update Submit

March 25, 2015

Conditions

Outcome Measures

Primary Outcomes (3)

  • demographic aspects

    demographic aspects (age, social status) of osteoporosis associated vertebral fractures treated with either operation or non operative treatment

    at least two year follow up

  • gender aspects

    gender aspects (sex) of osteoporosis associated vertebral fractures treated with either operation or non operative treatment

    at least two year follow up

  • socio economic aspects

    socio-economic aspects (cost ratio) of osteoporosis associated vertebral fractures treated with either operation or non operative treatment

    at least two year follow up

Study Arms (1)

osteoporosis associated vertebral fractures

Analyzation of demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures.

Procedure: OperationProcedure: Non-operative treatment

Interventions

OperationPROCEDURE

Analyzation of demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures treated with operation.

osteoporosis associated vertebral fractures

Analyzation of demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures treated with non-operative treatment.

osteoporosis associated vertebral fractures

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study was a retrospective case series of 694 patients, in which the fracture was caused due to primary or secondary osteoporosis, and who were treated at the department of trauma surgery at our level-I trauma center.

You may qualify if:

  • patients older than 50 years of age with vertebral fractures at the thoracic or lumbar spine caused by a low-energy trauma or without any trauma, or with vertebral fractures at the thoracic or lumbar spine with typical osteoporotic deformity of the vertebrae (wedge, fish, or flat)

You may not qualify if:

  • patients younger than 50 years of age
  • vertebral fractures at the cervical spine
  • vertebral fractures at the thoracic or lumbar spine caused by a high-energy trauma (motor-vehicle accident, sports-related accident, fall from a considerable height)
  • patients suffering from a malignancy, making a pathological fracture presumably, patients with vertebral fractures, whose dataset of follow-up monitoring was lacking, to make an evaluation of osteoporotic involvement impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoporotic Fractures

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 20, 2015

First Posted

March 31, 2015

Study Start

January 1, 2011

Primary Completion

March 1, 2015

Last Updated

March 31, 2015

Record last verified: 2015-03