Investigational vertebroplasty efficacy and safety trial: a sham-controlled trial of percutaneous vertebroplasty

ISRCTN	ISRCTN81871888
DOI	https://doi.org/10.1186/ISRCTN81871888
ClinicalTrials.gov (NCT)	NCT00068822
Protocol serial number	AR49070-01
Sponsor	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (National Institutes of Health [NIH]) (USA)
Funder	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (National Institutes of Health [NIH]) (USA) (ref: AR49373-01)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr David Kallmes
Scientific

200 1st Street SW
SMH MB M-611
Rochester, MN
55905
United States of America

Phone	+1 (0)507 255 1964
Email	kallmes.david@mayo.edu

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	INvestigational Vertebroplasty Efficacy and Safety Trial: a sham-controlled trial of percutaneous vertebroplasty
Study acronym	INVEST
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Back-specific functional status using Roland Scale at the one-month time frame.
Key secondary outcome measure(s)	Health status outcome using 36-item Short Form health survey (SF-36).
Completion date	01/12/2008

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	294
Key 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
Key exclusion criteria	1. Malignant tumour or spinal canal compromise 2. Local or systemic infection 3. Pregnancy 4. Hip fracture
Date of first enrolment	01/12/2003
Date of final enrolment	01/12/2008

200 1st Street SW

Rochester, MN
55905
United States of America

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	06/08/2009	11/04/2019	Yes	No
Results article	results	01/10/2013	11/04/2019	Yes	No
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

11/04/2019: Publication reference added.
21/03/2016: added link to results - basic reporting.