NCT01990365

Brief Summary

Many patients with acute osteoporotic vertebral fracture (acute OVFs) admitted because of low back pain. But there are only part of patients with acute OVFs, because some patients do not have low back pain although OVFs occurred.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

5.2 years

First QC Date

November 15, 2013

Last Update Submit

October 18, 2016

Conditions

Osteoporotic Vertebral Fracture

Keywords

Vertebral fracture, low back pain, gips, mobility

Outcome Measures

Primary Outcomes (1)

  • Relationship between dynamic mobility of acute vertebral fracture body and low back pain

    The investigators plan to analyze 300 patients who presented with acute back pain and were diagnosed as having acute OVFs on MRI. All radiographs were taken at the initial visit. Fracture mobility was determined by comparing cross-table supine lateral radiographs with sitting lateral radiographs (dynamic radiography). Mobility was considered present when a measurable change in vertebral body height occurred between supine and sitting radiographs.We also evaluate low back pain using visual analog scale (VAS) score. Then the patients undergo external fixation using Gips. After Gips fixation, dynamic radiography was performed again to evaluate reduction of dynamic mobility of the OVF body. VAS score was also evaluated after external fixation. We investigate patients' background such as age, sex, bone mineral density, etc. We performed statical analyses to determine the factors which related to low back pain after acute OVFs, especially fracture mobility.

    Up to 36 months

Eligibility Criteria

Age45 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Osteoporotic patients with acute vertbral fracture

You may qualify if:

  • Patients with acute osteoporosis fractures

You may not qualify if:

  • Patients without acute osteoporosis fractures (metastasis, infection, deformity,etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tomidahama Hospital

Yokkaichi, Mie-ken, 510-8008, Japan

RECRUITING

MeSH Terms

Conditions

Spinal FracturesLow Back Pain

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and InjuriesFractures, BoneBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Hospital

Study Record Dates

First Submitted

November 15, 2013

First Posted

November 21, 2013

Study Start

January 1, 2012

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

October 19, 2016

Record last verified: 2016-10

Locations

JP(1)