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 measure
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 (if study stopped)
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
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
Basic results (scientific)
See https://clinicaltrials.gov/ct2/show/results/NCT00068822
Publication list