Vertebral Compression FractureSOFTBONENCT05676320
Investigating Bone Cement With or Without Inossia® Cement Softener for Vertebral Compression Fractures
A study testing V-Flex and V-Steady in people with Vertebral Compression Fracture, run by Inossia AB at 9 sites in 4 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Compression Fracture
- What is being tested?
- V-Flex and V-Steady
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 11 Mar 2021to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Spain5 sites
Clínico San Carlos
Madrid
Fundación Jiménez Díaz
Madrid
Puerta de Hierro
Madrid
Hopsital Medina del Campo
Medina del Campo
University Hospital in Valladolid
Valladolid
Germany2 sites
Mannheim University Hospital
Mannheim
Hospital in Mechernich
Mechernich
About this study
Official title: 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).
Read the 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.
- Conditions
- Vertebral Compression Fracture
- Being tested
- V-Flex, V-Steady
- Keywords
- vertebral compression fracture, bone cement, vertebroplasty, kyphoplasty, osteoporosis, softener
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-FlexDevice
Bone cement including Inossia® Cement Softener. Treatment for vertebral compression fracture
V-SteadyDevice
Bone Cement alone
| Study group | Role | What they receive |
|---|---|---|
| V-Flex | Experimental | Bone cement including Inossia® Cement Softener Receives: Device: V-Flex |
| V-Steady | Active comparator | Bone Cement alone Receives: Device: V-Steady |
What is being measured
The primary outcome is the main question the study is designed to answer.
New fractures
To assess the effectiveness after administration of V-Flex compared to V-Steady as measured by reduction of new radiologically confirmed fractures.
Measured: 1 year
Location of fractures
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.
Measured: 1 year
Timing of fractures
Assess the timing of adjacent, non-adjacent and re-fractures of the treated vertebra after administration of the investigational device compared to PMMA.
Measured: 1 year
Secondary outcomes (8)
Function by ODI
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
Measured: 24 months
Pain measured by VAS
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
Measured: 24 months
Health related quality of life by SF-12
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
Measured: 24 months
Safety measured by adverse events
Asses the safety of Inossia™ Cement Softener as measured by adverse events
Measured: 24 months
Hospital Beds
Record the number of hospital bed days (within hospital, nursing home, etc.) during the first week
Measured: 1 week
The vertebral height
The vertebral height at 12 months and 24 months compared to baseline by X-ray (Average Mid Vertebral Body Height)
Measured: 24 month
Analgesic use
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
Measured: 24 months
Osteoporotic treatment regimen checklist
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start11 Mar 2021
- Primary completion20 Oct 2025
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Vertebral Compression FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inossia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EIT Health, Uppsala University
- Responsible party
- Sponsor
- Investigators
- David Noriega, Principal investigator, University Hospital in Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676320
- Sponsor's protocol ID
- SOFTBONE 1512:1
- Acronym
- SOFTBONE
- Status last verified
- Apr 2026
- First submitted
- 14 Dec 2022
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cooper C, Atkinson EJ, O'Fallon WM, Melton LJ 3rd. Incidence of clinically diagnosed vertebral fractures: a population-based study in Rochester, Minnesota, 1985-1989. J Bone Miner Res. 1992 Feb;7(2):221-7. doi: 10.1002/jbmr.5650070214.
PubMed 1570766Leidig G, Minne HW, Sauer P, Wuster C, Wuster J, Lojen M, Raue F, Ziegler R. A study of complaints and their relation to vertebral destruction in patients with osteoporosis. Bone Miner. 1990 Mar;8(3):217-29. doi: 10.1016/0169-6009(90)90107-q.
PubMed 2322694International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. N Engl J Med. 1997 Jan 23;336(4):309-15. doi: 10.1056/NEJM199701233360422. No abstract available.
PubMed 8995096International Conference on Harmonisation. ICH Harmonised Tripartite Guideline. Good Clinical Practice. 1-5-1996.
Code of Federal Regulations. Title 21, Volume 8. Part 812, Investigational Device Exemptions, Revised 2006.
World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. 52nd WMA General Assembly, Edinburgh, Scotland, October 2000. Last amended with Note of Clarification of Paragraph 29 by the WMA General Assembly, Washington 2002 and Note of Clarification on Paragraph 30 by the WMA General assembly, Tokyo 2004.
de Bruin TW. Iodide-induced hyperthyroidism with computed tomography contrast fluids. Lancet. 1994 May 7;343(8906):1160-1. doi: 10.1016/s0140-6736(94)90265-8. No abstract available.
PubMed 7910248ICH Harmonised Tripartite Guideline. Statistical principles for clinical trials. International Conference on Harmonisation E9 Expert Working Group. Stat Med. 1999 Aug 15;18(15):1905-42. No abstract available.
PubMed 10532877Lane JI, Maus TP, Wald JT, Thielen KR, Bobra S, Luetmer PH. Intravertebral clefts opacified during vertebroplasty: pathogenesis, technical implications, and prognostic significance. AJNR Am J Neuroradiol. 2002 Nov-Dec;23(10):1642-6.
PubMed 12427615Trout AT, Kallmes DF, Gray LA, Goodnature BA, Everson SL, Comstock BA, Jarvik JG. Evaluation of vertebroplasty with a validated outcome measure: the Roland-Morris Disability Questionnaire. AJNR Am J Neuroradiol. 2005 Nov-Dec;26(10):2652-7.
PubMed 16286418Trout AT, Gray LA, Kallmes DF. Vertebroplasty in the inpatient population. AJNR Am J Neuroradiol. 2005 Aug;26(7):1629-33.
PubMed 16091505Layton KF, Thielen KR, Koch CA, Luetmer PH, Lane JI, Wald JT, Kallmes DF. Vertebroplasty, first 1000 levels of a single center: evaluation of the outcomes and complications. AJNR Am J Neuroradiol. 2007 Apr;28(4):683-9.
PubMed 17416821Voormolen MH, van Rooij WJ, Sluzewski M, van der Graaf Y, Lampmann LE, Lohle PN, Juttmann JR. Pain response in the first trimester after percutaneous vertebroplasty in patients with osteoporotic vertebral compression fractures with or without bone marrow edema. AJNR Am J Neuroradiol. 2006 Aug;27(7):1579-85.
PubMed 16908585Palussiere J, Berge J, Gangi A, Cotten A, Pasco A, Bertagnoli R, Jaksche H, Carpeggiani P, Deramond H. Clinical results of an open prospective study of a bis-GMA composite in percutaneous vertebral augmentation. Eur Spine J. 2005 Dec;14(10):982-91. doi: 10.1007/s00586-003-0664-2. Epub 2005 Jun 2.
PubMed 15931511Cortet B, Cotten A, Boutry N, Flipo RM, Duquesnoy B, Chastanet P, Delcambre B. Percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fractures: an open prospective study. J Rheumatol. 1999 Oct;26(10):2222-8.
PubMed 10529144
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05676320
- Acronym / sponsor ID
- SOFTBONE / SOFTBONE 1512:1
- Conditions
- Vertebral Compression Fracture
- Keywords
- vertebral compression fracture, bone cement, vertebroplasty, kyphoplasty, osteoporosis, softener
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Inossia ABIndustry (pharma, biotech, devices)
- Collaborators
- EIT Health, Uppsala University
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V-Flex | Experimental | Device: V-FlexBone cement including Inossia® Cement Softener |
| V-Steady | Active comparator | Device: V-SteadyBone Cement alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V-FlexBone cement including Inossia® Cement Softener. Treatment for vertebral compression fracture | Device | V-Flex |
| V-SteadyBone Cement alone | Device | V-Steady |
Primary outcome
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.
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.
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.
8 secondary outcomes
Function by ODI
Time frame: 24 months
Pain measured by VAS
Time frame: 24 months
Health related quality of life by SF-12
Time frame: 24 months
Safety measured by adverse events
Time frame: 24 months
Hospital Beds
Time frame: 1 week
The vertebral height
Time frame: 24 month
Analgesic use
Time frame: 24 months
Osteoporotic treatment regimen checklist
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 1570766Cooper C, Atkinson EJ, O'Fallon WM, Melton LJ 3rd. Incidence of clinically diagnosed vertebral fractures: a population-based study in Rochester, Minnesota, 1985-1989. J Bone Miner Res. 1992 Feb;7(2):221-7. doi: 10.1002/jbmr.5650070214.
- Background: PubMed 2322694Leidig G, Minne HW, Sauer P, Wuster C, Wuster J, Lojen M, Raue F, Ziegler R. A study of complaints and their relation to vertebral destruction in patients with osteoporosis. Bone Miner. 1990 Mar;8(3):217-29. doi: 10.1016/0169-6009(90)90107-q.
- Background: PubMed 8995096International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. N Engl J Med. 1997 Jan 23;336(4):309-15. doi: 10.1056/NEJM199701233360422. No abstract available.
- BackgroundInternational Conference on Harmonisation. ICH Harmonised Tripartite Guideline. Good Clinical Practice. 1-5-1996.
- BackgroundCode of Federal Regulations. Title 21, Volume 8. Part 812, Investigational Device Exemptions, Revised 2006.
- BackgroundWorld Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. 52nd WMA General Assembly, Edinburgh, Scotland, October 2000. Last amended with Note of Clarification of Paragraph 29 by the WMA General Assembly, Washington 2002 and Note of Clarification on Paragraph 30 by the WMA General assembly, Tokyo 2004.
- Background: PubMed 7910248de Bruin TW. Iodide-induced hyperthyroidism with computed tomography contrast fluids. Lancet. 1994 May 7;343(8906):1160-1. doi: 10.1016/s0140-6736(94)90265-8. No abstract available.
- Background: PubMed 10532877ICH Harmonised Tripartite Guideline. Statistical principles for clinical trials. International Conference on Harmonisation E9 Expert Working Group. Stat Med. 1999 Aug 15;18(15):1905-42. No abstract available.
- Background: PubMed 12427615Lane JI, Maus TP, Wald JT, Thielen KR, Bobra S, Luetmer PH. Intravertebral clefts opacified during vertebroplasty: pathogenesis, technical implications, and prognostic significance. AJNR Am J Neuroradiol. 2002 Nov-Dec;23(10):1642-6.
- Background: PubMed 16286418Trout AT, Kallmes DF, Gray LA, Goodnature BA, Everson SL, Comstock BA, Jarvik JG. Evaluation of vertebroplasty with a validated outcome measure: the Roland-Morris Disability Questionnaire. AJNR Am J Neuroradiol. 2005 Nov-Dec;26(10):2652-7.
- Background: PubMed 16091505Trout AT, Gray LA, Kallmes DF. Vertebroplasty in the inpatient population. AJNR Am J Neuroradiol. 2005 Aug;26(7):1629-33.
- Background: PubMed 17416821Layton KF, Thielen KR, Koch CA, Luetmer PH, Lane JI, Wald JT, Kallmes DF. Vertebroplasty, first 1000 levels of a single center: evaluation of the outcomes and complications. AJNR Am J Neuroradiol. 2007 Apr;28(4):683-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Noriega principal investigator
University Hospital in Valladolid
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V-Flex and V-Steady in people with Vertebral Compression Fracture, run by Inossia AB at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, Germany, Canada, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New fractures (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05676320, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.