Investigating Bone Cement With or Without Inossia® Cement Softener for Vertebral Compression Fractures (SOFTBONE)

April 2, 2026 updated by: Inossia AB

A Multicentre, Single-blind, RCT to Document the Safety and Efficacy of the Use of a Bone Cement With or Without Inossia® Cement Softener for Patients With Vertebral Compression Fractures

The overall purpose of conducting this study is to evaluate the safety and efficacy of V-Flex and V-Steady for augmentation of osteoporotic vertebral compression fractures and to verify that adding a cement softener into a PMMA bone cement is comparable to a PMMA bone cement alone (V-Steady).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The clinical investigation is a prospective, single-blind, controlled multi-center study of vertebral compression fractures treated by vertebroplasty or kyphoplasty with PMMA alone (V-Steady) or PMMA mixed with Inossia® Cement Softener (V-Flex).

The overall purpose of conducting this study is to confirm the safety and efficacy of Inossia® Cement Softener mixed with PMMA for augmentation of osteoporotic vertebral compression fractures and to verify that the V-Flex is, at least, comparable (non-inferior) to the PMMA products used today.

All eligible patients will be invited to participate in the study. A total of 203 patients were enrolled in the study.

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Beam Radiology
  • Germany
      • Mannheim, Germany
        • Mannheim University Hospital
      • Mechernich, Germany
        • Hospital in Mechernich
  • Poland
      • Lodz, Poland
        • Lodz University Hospital
  • Spain
      • Madrid, Spain
        • Fundacion Jimenez Diaz
      • Madrid, Spain
        • Clinico San Carlos
      • Madrid, Spain
        • Puerta de Hierro
      • Medina del Campo, Spain
        • Hopsital Medina del Campo
      • Valladolid, Spain
        • University Hospital in Valladolid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Informed consent obtained before any study-related activities (study-related activities are any procedures that would not have been performed during normal management of the patient, i.e. standard of care);
  • Symptomatic osteoporotic vertebral compression fracture without prior or not responding to medical treatment within 6 months;
  • Maximum of 1 level of vertebral compression fractures eligible for treatment localized at level Th5 to L5 and verified by MRI or bone scan;
  • Height reduction of the affected vertebra(e) with an anterior wall compression of not exceeding 60% compared to the nearest normal vertebral body determined by X-ray;
  • Have pain correlating to the fractured levels requiring regular analgesic intake and/or causing substantial disability of daily life;
  • Pain score ≥ 40 mm measured by VAS correlating to at least one of the fracture levels (scale 0 - 100 mm) at the screening visit;
  • Oswestry Disability Index > 20 (0 - 100 scale);
  • SF-12PCS Index < 80 (0 - 100 scale);
  • Patient with a communicative ability to understand the procedure and participate in the study and comply with the follow up program.

Exclusion Criteria:

  • Patients below 18 years;
  • Any burst fracture;
  • Unstable fractures defined by neurological deficit or interspinous process widening as evaluated by the Investigator, as well as kyphosis > 30°, translation > 4 mm;
  • Established or suspected malignancy of the fractured vertebra. Hemangioma of the fractured vertebra;
  • High energy trauma or clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis as suggested by progressive weakness;
  • Have neurologic symptoms or deficits, or radiculopathy related to the fractured vertebrae;
  • Patients with extremely high BMI, i.e. BMI ≥ 40;
  • Previously treated with vertebroplasty or kyphoplasty;
  • Patients with concomitant diseases which may be worsened by invasive treatment of the fracture such as e.g. severe cardiopulmonary dysfunction (including aortic aneurysm), as judged by the Investigator
  • Irreversible coagulopathy or bleeding disorder. Note regarding reversible coagulopathies: Patients on Coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re- initiation of anticoagulants;
  • Active systemic infection or local skin infection at the puncture site;
  • Pregnancy or breast-feeding;
  • Patients with known chemical dependency or drugs or with a medical history of drug abuse;
  • Patients who are serving prison sentence;
  • Have participated in another investigational study within 30 days prior to inclusion
  • Pacemaker
  • Previous or active radiotherapy affecting the spine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: V-Steady
Bone Cement alone
Device: V-Steady
Bone Cement alone
Experimental: V-Flex
Bone cement including Inossia® Cement Softener
Device: V-Flex
Bone cement including Inossia® Cement Softener. Treatment for vertebral compression fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Location of fractures
Time Frame: 1 year
Assess the location of new fractures: adjacent or non-adjacent to the treated vertebral or re-fractures of the treated vertebra after administration of the investigational device compared to PMMA.
1 year
Timing of fractures
Time Frame: 1 year
Assess the timing of adjacent, non-adjacent and re-fractures of the treated vertebra after administration of the investigational device compared to PMMA.
1 year
New fractures
Time Frame: 1 year
To assess the effectiveness after administration of V-Flex compared to V-Steady as measured by reduction of new radiologically confirmed fractures.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Beds
Time Frame: 1 week
Record the number of hospital bed days (within hospital, nursing home, etc.) during the first week
1 week
Function by ODI
Time Frame: 24 months
Assess the change in function at time points 5 days, 3 months, 12 months, and 24 months after administration of the investigational device compared to PMMA as measured by Oswestry Disability Index (ODI): scale 0-100% where a higher score means a worse outcome
24 months
Pain measured by VAS
Time Frame: 24 months
Assess the change in back pain at time points 5 days, 3 months, 12 months, and 24 months after administration of the investigational device compared to PMMA as measured by Visual Analogue Scale (VAS): scale 0-100, where 0 is no pain and 100 is the worst pain imaginable
24 months
Health related quality of life by SF-12
Time Frame: 24 months
Assess the change in health related quality of life at time points 5 days, 3 months, 12 months, and 24 months after administration of the investigational device compared to PMMA as measured by SF-12: scale 0-100 where a higher score means a better outcome
24 months
Safety measured by adverse events
Time Frame: 24 months
Asses the safety of Inossia™ Cement Softener as measured by adverse events
24 months
The vertebral height
Time Frame: 24 month
The vertebral height at 12 months and 24 months compared to baseline by X-ray (Average Mid Vertebral Body Height)
24 month
Analgesic use
Time Frame: 24 months
Record the analgesic use at time points 5 days, 3 months, 12 months, and 24 months after administration of the investigational device compared to PMMA and compare to the WHO analgestic ladder
24 months
Osteoporotic treatment regimen checklist
Time Frame: 24 months
Record the osteoporotic treatment regimen at time points 5 days, 3 months, 12 months, and 24 months after administration of the investigational device compared to PMMA
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inossia AB

Collaborators

Uppsala University
EIT Health

Investigators

  • Principal Investigator: David Noriega, University Hospital in Valladolid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2021

Primary Completion (Actual)

October 20, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

January 6, 2023

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOFTBONE 1512:1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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