NCT00203554

Brief Summary

The purpose of this study is to compare the effect of vertebroplasty with that of traditional medical treatment in the treatment of painful vertebral fractures in osteoporotic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable pain

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

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

March 27, 2008

Status Verified

March 1, 2008

Enrollment Period

3.8 years

First QC Date

September 16, 2005

Last Update Submit

March 26, 2008

Conditions

PainOsteoporosisFracture

Keywords

osteoporosisvertebrafracturepainpercutaneousvertebroplastypolymethylmetacrylate

Outcome Measures

Primary Outcomes (1)

  • Level of pain

    before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.

Secondary Outcomes (1)

  • Needs for analgetics, number of days at hospital, level of ADL

    before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.

Interventions

Poly methylmetacrylate, PMMAGENETIC

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • new pain in spine (within 6 months)
  • x-ray verified low energy spinal fracture(s)

You may not qualify if:

  • less than 20% or more than 90% reduction of the vertebral height
  • lack of pain at fracture level
  • no need for continuous analgesic treatment
  • patient no able to communicate
  • general anaesthesia contraindicated
  • MRI not possible
  • coagulopathy (not adjustable)
  • spondylitis
  • discitis
  • spinal metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep of Neuroradiology, Aarhus University Hospital

Aarhus, DK 8000, Denmark

Location

MeSH Terms

Conditions

PainOsteoporosisFractures, Bone

Interventions

Polymethyl Methacrylate

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

MethylmethacrylatesPolymethacrylic AcidsAcrylatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAcrylic ResinsResins, SyntheticPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Leif Sorensen, Consultant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 20, 2005

Study Start

March 1, 2004

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

March 27, 2008

Record last verified: 2008-03

Locations

DK(1)