Osteoporosis FractureNCT06586996
The Construction of Bidirectional Column Study of Acute Osteoporotic Vertebral Compression Fractures
An observational study of Osteoporosis Fracture, run by Peking University Third Hospital at 1 site in China.
Trial summary
Our research group plans to establish a disease specific bidirectional cohort study on prognosis prediction of acute osteoporotic vertebral compression fracture based on imaging and clinical data, and to establish a comprehensive bioinformation database on OVCFs, including patient status, clinical data, laboratory… Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Osteoporosis Fracture
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2024
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the acute osteoporosis vertebral compression fracture patients who search for treatments in our hospital
Inclusion Criteria: all patients who suffer a acute osteoporosis vertebral compression fractures -
Exclusion Criteria: those who have endocrine disease which have impacts on the bone density
-
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospita
Beijing, 100083
Yun Tian, M.D, +8613701053505, tiany@bjmu.edu.cn
About this study
Official title: The Construction of Bidirectional Column Study and Prognosis Prediction of Acute Osteoporotic Vertebral Compression Fractures Based on Imaging and Clinical Data
Our research group plans to establish a disease specific bidirectional cohort study on prognosis prediction of acute osteoporotic vertebral compression fracture based on imaging and clinical data, and to establish a comprehensive bioinformation database on OVCFs, including patient status, clinical data, laboratory examination, and imaging examination database
- Conditions
- Osteoporosis Fracture
- Being tested
- no intervention
- Keywords
- osteoporosis fracture
- Medical subject headings
- Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| osteoporotic vertebral compression fractures | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS value
the visual analogue scale value of patient
Measured: 2 weeks, 1 month, 2 months, 3months, 6 months and 12 months
vertebrae height
the height of the vertebrae according to the X rays
Measured: 2 weeks, 1 month, 2 months, 3months, 6 months and 12 months
T value
the T value of the dual energy X-ray absorptiometry
Measured: 6months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis FractureStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586996
- Sponsor's protocol ID
- M2021606
- Status last verified
- Jan 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Construction of Bidirectional Column Study and Prognosis Prediction of Acute Osteoporotic Vertebral Compression Fractures Based on Imaging and Clinical Data
- ClinicalTrials.gov ID
- NCT06586996
- Acronym / sponsor ID
- M2021606
- Conditions
- Osteoporosis Fracture
- Keywords
- osteoporosis fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Sep 2024 (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.
Our research group plans to establish a disease specific bidirectional cohort study on prognosis prediction of acute osteoporotic vertebral compression fracture based on imaging and clinical data, and to establish a comprehensive bioinformation database on OVCFs, including patient status, clinical data, laboratory examination, and imaging examination database
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| osteoporotic vertebral compression fractures | – | Other: no intervention |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the acute osteoporosis vertebral compression fracture patients who search for treatments in our hospital
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 |
|---|---|---|
| no interventionno intervention | Other | osteoporotic vertebral compression fractures |
Primary outcome
VAS value
Time frame: 2 weeks, 1 month, 2 months, 3months, 6 months and 12 months
the visual analogue scale value of patient
vertebrae height
Time frame: 2 weeks, 1 month, 2 months, 3months, 6 months and 12 months
the height of the vertebrae according to the X rays
T value
Time frame: 6months and 12 months
the T value of the dual energy X-ray absorptiometry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis Fracture, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS value (time frame: 2 weeks, 1 month, 2 months, 3months, 6 months and 12 months). 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?
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 19 Sep 2024.