Vertebral Compression FractureNCT04835428
STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures
A study testing Treatment Group: AGN1 LOEP SV Kit in people with Vertebral Compression Fracture and Compression Fracture, run by AgNovos Healthcare, LLC at 12 sites in United States.
Trial summary
This is a multicenter, single-blinded, randomized controlled clinical trial evaluating the safety and efficacy of the AGN1 LOEP SV Kit for the treatment of painful vertebral compression fragility fractures (VCFs). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Vertebral Compression Fracture, Compression Fracture, Vertebral Compression
- What is being tested?
- Treatment Group: AGN1 LOEP SV Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 12 sitesUnited States
- Study dates
- 31 May 2022to 31 Dec 2029
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a male or female 50 years of age or older at the time of study treatment.
- Subject has one (1) or two (2) acute VCF(s). Note that subjects are eligible if they have an asymptomatic, healed VCF(s) at any non-target vertebral level.
- Each target VCF meets all of the following criteria:
- Due to diagnosed or presumed underlying osteoporosis
- T1 to L5 inclusively
- Target VCF-related pain ≤ 6 months at time of study treatment
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- Each target VCF shows loss of height of the vertebral body ≤ 50% based on X-ray at baseline.
- Each target VCF is acute or persistent (not healed), as demonstrated on imaging, including T2-weighted, STIR MRI, bone scan or bone scan with SPECT/CT, serial radiographs, or other serial imaging demonstrating acuity.
- Focal tenderness to palpation of the spinal process of each target VCF on the physical exam correlates with imaging.
- Subject has failed conservative medical therapy (bed rest, observation, chiropractic care, orthotics, opioid and non-opioid analgesics, and/or physical therapy), defined as either having a VAS back pain score of ≥ 70 mm after 24 hours to 6 weeks of conservative care or a VAS back pain score of ≥ 50 mm after more than 6 weeks of conservative care.
- Subject has an Oswestry Disability Index (ODI) score of ≥ 30% at baseline.
- Subject is capable of giving written informed consent to participate in the study.
- The subject's willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full length of the study has been documented
Who cannot join
- At least one of the target VCF(s) is unstable, including split or burst fracture.
- Subject has a bleeding disorder.
- Subject has an active infection of the spine or surgical site.
- Subject has a bloodborne infection.
- At least one of the target VCFs is due to underlying or suspected tumor.
- At least one of the target VCFs is due to high-energy trauma.
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- At least one of the target VCFs is due to osteonecrosis.
- At least one of the target VCFs has a local kyphotic angle of > 30 degrees, measured as the angle between the superior endplate and inferior endplate at the target VCF.
- Subject has had any prior surgical treatment at the target vertebral level or adjacent vertebral levels.
- The pedicle(s) in the target vertebral body appears unable to safely accommodate transpedicular access instrumentation.
- Subject has neurologic symptoms, deficits, or radiculopathy related to the target VCF(s).
- Subject has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated.
- Subject has pain, progressive weakness, or paralysis due to herniated nucleus pulposus or spinal stenosis.
- Subject has spondylolisthesis > Grade 1 at target vertebral body(ies).
- Subject requires daily opioid medication for pain not related to the target VCF(s).
- Subject has severe cardiopulmonary deficiencies.
- Subject has a Body Mass Index (BMI) > 35.
- Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).
- Subject has a history of tuberculous spondylitis.
- Subject has a history of invasive malignancy within the last five (5) years, other than non-melanoma skin cancer. Subject is not excluded if they have a history of malignancy over 5 years ago treated with curative intent and without clinical signs or symptoms since then.
- Subject is on oral or parenteral immune-suppressive drugs.
- Subject has uncontrolled diabetes mellitus.
- Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min.
- Subject has a diagnosed calcium metabolism disorder.
- Subject has known allergies to calcium-based bone void fillers.
- Subject is pregnant or planning to become pregnant during participation in the study.
- In the judgment of the Investigator, the subject is not a good study candidate. (e.g. substance abuse or chemical dependency, inability to adhere to follow-up schedule, progression of the fracture between screening and the procedure visit).
- Subject is currently enrolled in another interventional clinical study.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
Lahey Medical Center
Burlington, Massachusetts, 01805
Rush University Medical Center
Chicago, Illinois, 60612
Endeavor Health
Evanston, Illinois, 60201
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160
Elite Pain and Spine Institute
Mesa, Arizona, 85203
Orlando Neurosurgery (Conquest Research)
Orlando, Florida, 32804
Pinehurst Surgical Clinic
Pinehurst, North Carolina, 28374
Texas Back Institute
Plano, Texas, 75093
Louisiana Spine Institute
Shreveport, Louisiana, 71101
Cleveland Clinic Florida
Stuart, Florida, 34994
Montefiore
The Bronx, New York, 10467
About this study
Official title: A Randomized, Single-Blinded, Non-Inferiority Study Comparing AGN1 Local Osteo-Enhancement Procedure (LOEP) SV Kit Treatment of Vertebral Compression Fragility Fractures to PMMA Bone Cement Treatment
This is a multicenter, single-blinded, randomized controlled clinical trial evaluating the safety and efficacy of the AGN1 LOEP SV Kit for the treatment of painful vertebral compression fragility fractures (VCFs). The objective of this study is to demonstrate non-inferiority of the AGN1 LOEP SV Kit for the treatment of VCFs to standard of care vertebroplasty treatment using bipedicular injection of PMMA bone cement.
Read the detailed description
Four hundred and eight (408) eligible subjects at up to twenty-five (25) study sites will be randomized 1:1 for treatment using the AGN1 LOEP SV Kit (Intervention Group) or PMMA bone cement (Active Control Group).
- Intervention Group - receives vertebral augmentation of the target VCF(s) using the AGN1 LOEP SV Kit
- Active Control Group - receives vertebral augmentation of the target VCF(s) using either Stryker VertaPlex HV or Medtronic Kyphon HV-R.
Follow-up visits will be conducted at 7 days, 28 days, 3 months, 12 months and 24 months after the procedure.
- Being tested
- Treatment Group: AGN1 LOEP SV Kit, Control Group: PMMA bone cement
- Keywords
- LOEP, AGN1, STAND, Local Osteo-Enhancement Procedure
- Medical subject headings
- Fractures, Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Group: AGN1 LOEP SV KitDevice
The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation. Following saline lavage to create space, the AGN1 implant material is injected and hardens in situ to augment the fractured vertebral body. The AGN1 implant material is then resorbed and replaced with new bone.
Control Group: PMMA bone cementDevice
High viscosity PMMA bone cement will be used for vertebral augmentation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with AGN1 LOEP SV Kit | Experimental | The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation. Following saline lavage to create space, the AGN1 implant material is injected and hardens in situ to augment the fractured vertebral body. The AGN1 implant material is then resorbed and replaced with new bone. Receives: Device: Treatment Group: AGN1 LOEP SV Kit |
| Treatment with PMMA bone cement | Active comparator | High viscosity PMMA bone cement will be used for vertebral augmentation. Receives: Device: Control Group: PMMA bone cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VCF-related Pain as measured by a 100 mm Visual Analogue Scale (VAS)
Change in VCF-related pain by > 20 mm from baseline as measured by a 100 mm Visual Analogue Scale (VAS) where 0mm is no pain, and 100mm is worst pain possible.
Measured: 24 months
Change in function
change of function from baseline as measured by the Oswestry Disability Index (ODI)
Measured: 24 months
Radiographic evidence of implant resorption (Intervention Group only)
change in resorption from procedure as assessed by independent radiographer
Measured: 24 months
Radiographic evidence of bone formation (Intervention Group only)
change in bone formation from procedure as assessed by independent radiographer
Measured: 24 months
Adverse events
Occurrence of device-related serious adverse events, device-related adverse events or serious adverse events categorized as failure or surgical intervention at the target level occurring post-treatment
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 posted8 Apr 2021
- Study start31 May 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Four hundred eight (408) eligible subjects at up to twenty-five (25) study sites will be randomized 1:1 for treatment using the AGN1 LOEP SV Kit (Intervention Group) or PMMA bone cement (Active Control Group).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AgNovos Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kern Singh, Principal investigator, Midwest Orthopedics at Rush
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835428
- Sponsor's protocol ID
- AGN-CIP-201
- Other IDs
- STAND
- Status last verified
- May 2026
- First submitted
- 5 Apr 2021
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blinded, Non-Inferiority Study Comparing AGN1 Local Osteo-Enhancement Procedure (LOEP) SV Kit Treatment of Vertebral Compression Fragility Fractures to PMMA Bone Cement Treatment
- ClinicalTrials.gov ID
- NCT04835428
- Acronym / sponsor ID
- AGN-CIP-201
- Keywords
- LOEP, AGN1, STAND, Local Osteo-Enhancement Procedure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- AgNovos Healthcare, LLCIndustry (pharma, biotech, devices)
- Study start
- 31 May 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 8 Apr 2021 (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.
This is a multicenter, single-blinded, randomized controlled clinical trial evaluating the safety and efficacy of the AGN1 LOEP SV Kit for the treatment of painful vertebral compression fragility fractures (VCFs). The objective of this study is to demonstrate non-inferiority of the AGN1 LOEP SV Kit for the treatment of VCFs to standard of care vertebroplasty treatment using bipedicular injection of PMMA bone cement.
Detailed description
Four hundred and eight (408) eligible subjects at up to twenty-five (25) study sites will be randomized 1:1 for treatment using the AGN1 LOEP SV Kit (Intervention Group) or PMMA bone cement (Active Control Group).
- Intervention Group - receives vertebral augmentation of the target VCF(s) using the AGN1 LOEP SV Kit
- Active Control Group - receives vertebral augmentation of the target VCF(s) using either Stryker VertaPlex HV or Medtronic Kyphon HV-R.
Follow-up visits will be conducted at 7 days, 28 days, 3 months, 12 months and 24 months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Four hundred eight (408) eligible subjects at up to twenty-five (25) study sites will be randomized 1:1 for treatment using the AGN1 LOEP SV Kit (Intervention Group) or PMMA bone cement (Active Control Group).
| Arm | Type | Receives |
|---|---|---|
| Treatment with AGN1 LOEP SV Kit | Experimental | Device: Treatment Group: AGN1 LOEP SV KitThe AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation. Following saline lavage to create space, the AGN1 implant material is injected and hardens in situ to augment the fractured vertebral body. The AGN1 implant material is then resorbed and replaced with new bone. |
| Treatment with PMMA bone cement | Active comparator | Device: Control Group: PMMA bone cementHigh viscosity PMMA bone cement will be used for vertebral augmentation. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject is a male or female 50 years of age or older at the time of study treatment.
- Subject has one (1) or two (2) acute VCF(s). Note that subjects are eligible if they have an asymptomatic, healed VCF(s) at any non-target vertebral level.
- Each target VCF meets all of the following criteria:
- Each target VCF shows loss of height of the vertebral body ≤ 50% based on X-ray at baseline.
- Each target VCF is acute or persistent (not healed), as demonstrated on imaging, including T2-weighted, STIR MRI, bone scan or bone scan with SPECT/CT, serial radiographs, or other serial imaging demonstrating acuity.
Key exclusion criteria (28 listed)
- At least one of the target VCF(s) is unstable, including split or burst fracture.
- Subject has a bleeding disorder.
- Subject has an active infection of the spine or surgical site.
- Subject has a bloodborne infection.
- At least one of the target VCFs is due to underlying or suspected tumor.
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 |
|---|---|---|
| Treatment Group: AGN1 LOEP SV KitThe AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation. Following saline lavage to create space, the AGN1 implant material is injected and hardens in situ to augment the fractured vertebral body. The AGN1 implant material is then resorbed and replaced with new bone. | Device | Treatment with AGN1 LOEP SV Kit |
| Control Group: PMMA bone cementHigh viscosity PMMA bone cement will be used for vertebral augmentation. | Device | Treatment with PMMA bone cement |
Primary outcome
Change in VCF-related Pain as measured by a 100 mm Visual Analogue Scale (VAS)
Time frame: 24 months
Change in VCF-related pain by > 20 mm from baseline as measured by a 100 mm Visual Analogue Scale (VAS) where 0mm is no pain, and 100mm is worst pain possible.
Change in function
Time frame: 24 months
change of function from baseline as measured by the Oswestry Disability Index (ODI)
Radiographic evidence of implant resorption (Intervention Group only)
Time frame: 24 months
change in resorption from procedure as assessed by independent radiographer
Radiographic evidence of bone formation (Intervention Group only)
Time frame: 24 months
change in bone formation from procedure as assessed by independent radiographer
Adverse events
Time frame: 24 months
Occurrence of device-related serious adverse events, device-related adverse events or serious adverse events categorized as failure or surgical intervention at the target level occurring post-treatment
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 May 2026.
- 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.
Kern Singh principal investigator
Midwest Orthopedics at Rush
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Group: AGN1 LOEP SV Kit in people with Vertebral Compression Fracture and Compression Fracture, run by AgNovos Healthcare, LLC at 12 sites in United States.
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 13 inclusion and 28 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 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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?
Change in VCF-related Pain as measured by a 100 mm Visual Analogue Scale (VAS) (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2026.