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New softer cement could reduce repeat spine fractures

NCT ID NCT05676320

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two bone cements used to treat painful spinal fractures caused by osteoporosis. One cement includes a softener (V-Flex) to make it less rigid, while the other is standard cement (V-Steady). The goal is to see if the softer cement reduces the chance of new fractures nearby and improves pain and function. About 200 participants with one recent fracture will be followed for two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bone cement with cement softener (Inossia® Cement Softener)
What this could lead to
If it works, this could provide a safer, more effective option for treating spinal fractures, potentially reducing the risk of new fractures nearby.
What could go wrong
This is a mid-stage trial with 203 participants, so results may not apply to everyone. Adding a softener might not improve outcomes and could introduce unknown risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

203 people

The number who actually took part.

Started

Mar 2021

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beam Radiology

    Calgary, Alberta, Canada

  • Clínico San Carlos

    Madrid, Spain

  • Fundación Jiménez Díaz

    Madrid, Spain

  • Hopsital Medina del Campo

    Medina del Campo, Spain

  • Hospital in Mechernich

    Mechernich, Germany

  • Lodz University Hospital

    Lodz, Poland

  • Mannheim University Hospital

    Mannheim, Germany

  • Puerta de Hierro

    Madrid, Spain

  • University Hospital in Valladolid

    Valladolid, Spain

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