Condition category
Musculoskeletal Diseases
Date applied
10/10/2003
Date assigned
11/11/2003
Last edited
21/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Kallmes

ORCID ID

Contact details

200 1st Street SW
SMH MB M-611
Rochester
MN
55905
United States of America
+1 (0)507 255 1964
kallmes.david@mayo.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00068822

Protocol/serial number

AR49070-01

Study information

Scientific title

INvestigational Vertebroplasty Efficacy and Safety Trial: a sham-controlled trial of percutaneous vertebroplasty

Acronym

INVEST

Study hypothesis

Vertebroplasty is a procedure used to stabilise broken vertebrae, the bones that form the spine. This study will evaluate the effectiveness of vertebroplasty for the treatment of fractures due to osteoporosis.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Osteoporosis with painful, crushed or broken vertebra (1 or 2 levels)

Intervention

Participants in this study will be randomly assigned to receive either percutaneous vertebroplasty or a sham procedure (placebo control group). Participants may have up to 2 spinal levels treated. Participants will be enrolled in the study for 1 year and will have study visits at entry and Months 1 and 12. There will also be phone visits at Days 1, 2, 3, and 14 and Months 3 and 6. After Month 1, crossover from the placebo group to the vertebroplasty group will be allowed.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Back-specific functional status using Roland Scale at the one-month time frame.

Secondary outcome measures

Health status outcome using 36-item Short Form health survey (SF-36).

Overall trial start date

01/12/2003

Overall trial end date

01/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Over 50 years old
2. Confirmed osteoporosis or osteopenia
3. Painful vertebral fracture
4. Refractory to medical therapy
5. No previous vertebroplasty or kyphoplasty
6. No infections or immunocompromised patients

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

294

Participant exclusion criteria

1. Malignant tumour or spinal canal compromise
2. Local or systemic infection
3. Pregnancy
4. Hip fracture

Recruitment start date

01/12/2003

Recruitment end date

01/12/2008

Locations

Countries of recruitment

United States of America

Trial participating centre

200 1st Street SW
Rochester, MN
55905
United States of America

Sponsor information

Organisation

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (National Institutes of Health [NIH]) (USA)

Sponsor details

Bethesda
Maryland
20810
United States of America

Sponsor type

Government

Website

http://www.niams.nih.gov/

Funders

Funder type

Government

Funder name

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (National Institutes of Health [NIH]) (USA) (ref: AR49373-01)

Alternative name(s)

NIAMS

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

See https://clinicaltrials.gov/ct2/show/results/NCT00068822

Publication summary

Publication citations

Additional files

Editorial Notes

21/03/2016: added link to results - basic reporting.