Osteoporotic Vertebral Compression FractureNCT02902250
The Comparative Study About the Effect of Vertebral Body Decompression Procedure
A study testing Decompression and Conservative Treatment in people with Osteoporotic Vertebral Compression Fracture, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the treatment efficacy between vertebral body decompression procedure and conservative treatment with non-inferiority design Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Osteoporotic Vertebral Compression Fracture
- What is being tested?
- Decompression and Conservative Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jun 2017to 20 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteoporotic vertebral compression fracture
Who cannot join
- malignancy or inflammatory disease
- severe pain in other joints
- coagulopathy
- an inappropriate person considered by investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyounggido
About this study
Official title: The Comparative Study About the Effect of Vertebral Body Decompression Procedure and Conservative Treatment for Benign Vertebral Compression Fracture - Prospective Randomized Control Study
The purpose of this study is to compare the treatment efficacy between vertebral body decompression procedure and conservative treatment with non-inferiority design
- Being tested
- Decompression, Conservative Treatment
- Keywords
- Vertebroplasty, Core decompression, Osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecompressionProcedure or surgery
vertebral body decompression in compression fracture
Conservative TreatmentProcedure or surgery
Conservative Treatment in vertebral compression fracture
| Study group | Role | What they receive |
|---|---|---|
| Decompression | Experimental | bone marrow decompression at fractured vertebral body Receives: Procedure: Decompression |
| Conservative Treatment | Active comparator | Conservative Treatment for compression fracture Receives: Procedure: Conservative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Scale
Pain status
Measured: until 3 months after procedure
Secondary outcomes (4)
Oswestry Disability Index
Health status
Measured: until 3 months after procedure
EQ5D-5L
Quality of Life
Measured: until 3 months after procedure
Leed Dyspepsia Questionnaire
Abdominal discomfort d/t medication and injection
Measured: until 3 months after procedure
Radiographic outcome
Compression rate
Measured: until 3 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study start8 Jun 2017
- Primary completion15 Feb 2022
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic Vertebral Compression FractureStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin S. Yeom, Seoul National University Hospital
- Investigators
- Sang-Min Park, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902250
- Sponsor's protocol ID
- Decon_001
- Status last verified
- Jan 2023
- First submitted
- 10 Sep 2016
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Study About the Effect of Vertebral Body Decompression Procedure and Conservative Treatment for Benign Vertebral Compression Fracture - Prospective Randomized Control Study
- ClinicalTrials.gov ID
- NCT02902250
- Acronym / sponsor ID
- Decon_001
- Keywords
- Vertebroplasty, Core decompression, Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 15 Sep 2016 (estimated)
- 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 purpose of this study is to compare the treatment efficacy between vertebral body decompression procedure and conservative treatment with non-inferiority design
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decompression | Experimental | Procedure: Decompressionbone marrow decompression at fractured vertebral body |
| Conservative Treatment | Active comparator | Procedure: Conservative TreatmentConservative Treatment for compression fracture |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- osteoporotic vertebral compression fracture
Key exclusion criteria (4 listed)
- malignancy or inflammatory disease
- severe pain in other joints
- coagulopathy
- an inappropriate person considered by investigator
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 |
|---|---|---|
| Decompressionvertebral body decompression in compression fracture | Procedure or surgery | Decompression |
| Conservative TreatmentConservative Treatment in vertebral compression fracture | Procedure or surgery | Conservative Treatment |
Primary outcome
Visual Analog Pain Scale
Time frame: until 3 months after procedure
Pain status
4 secondary outcomes
Oswestry Disability Index
Time frame: until 3 months after procedure
EQ5D-5L
Time frame: until 3 months after procedure
Leed Dyspepsia Questionnaire
Time frame: until 3 months after procedure
Radiographic outcome
Time frame: until 3 months after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
Sang-Min Park, MD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decompression and Conservative Treatment in people with Osteoporotic Vertebral Compression Fracture, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analog Pain Scale (time frame: until 3 months after procedure). 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 5 Jan 2023; AzTrials last refreshed its copy on 30 Oct 2026.