Osteoporotic FracturesNCT05848167
Senile Osteoporotic Fractures Cohort Study（SOFCS）
An observational study of Osteoporotic Fractures, run by Suzhou Municipal Hospital at 1 site in China.
Trial summary
Osteoporotic fracture is one of the main causes of disability and death in elderly patients. Specific disease cohort study is an important basis for accurate prevention and treatment of senile osteoporotic fractures. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporotic Fractures
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2021to 14 Jul 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Elderly patients after operation of osteoporotic fracture.
Who may be able to join
- Patients ≥65 years old
- Patients with osteoporosis
- No gender limitation
Who cannot join
- < 65 years old;
- Non-osteoporotic fracture;
- Alzheimer's disease;
- Bone tumors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215000
Hao Y feng, doctor, 13913109339, 13913109339@163.com
Che Y jun, doctor, 19941919699, cheyanjun1980@hotmail.com
About this study
Official title: Senile Osteoporotic Fractures Cohort Study
Osteoporotic fracture is one of the main causes of disability and death in elderly patients. Specific disease cohort study is an important basis for accurate prevention and treatment of senile osteoporotic fractures. Investigators plan to collect and manage the baseline and clinical information of more than 2000 elderly patients with osteoporotic fractures after surgery through the platform of special disease collaborative prevention and treatment system and medical record database of Suzhou Municipal Hospital in two years, and carry out short-term and long-term follow-up observation.
Read the detailed description
Osteoporotic fracture is one of the main causes of disability and death in elderly patients. Compared with patients with no history of fractures, the risk of a second fracture after an initial fracture doubled, with a fatality rate of up to 34.8%. There has been a lot of progress in the diagnosis and treatment of osteoporotic fractures in the elderly. However, there are few reports on the diagnosis and treatment of osteoporotic fractures in the elderly after surgery. Based on previous studies, it is found that the re-fracture after operation of osteoporotic fracture in the elderly is not only directly caused by the fall, but also caused by the interaction of multiple risk factors including environmental factors, physiological factors and neuroskeletal musculoskeletal system. Therefore, it is of great significance to break the traditional diagnosis and treatment mode, improve the diagnosis and treatment effect, and save medical resources to carry out research on the disease characteristics, rules and risk warning after senile osteoporotic fracture operation. Specific disease cohort study is an important basis for accurate prevention and treatment of senile osteoporotic fractures. Investigators plan to collect and manage the baseline and clinical information of more than 2000 elderly patients with osteoporotic fractures after surgery through the platform of special disease collaborative prevention and treatment system and medical record database of Suzhou Municipal Hospital in two years, and carry out short-term and long-term follow-up observation.
- Conditions
- Osteoporotic Fractures
- Keywords
- Senile osteoporotic fracture,Cohort study,mechanism,outcome
- Medical subject headings
- Osteoporotic Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
BMD
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start15 Jul 2021
- Primary completion14 May 2024 (estimated)
- Study completion14 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic FracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mo Zhou, Suzhou Municipal Hospital
- Investigators
- Hao Y feng, doctor, Study chair, Suzhou Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848167
- Sponsor's protocol ID
- GSKY20210404
- Status last verified
- Nov 2023
- First submitted
- 26 Apr 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Senile Osteoporotic Fractures Cohort Study
- ClinicalTrials.gov ID
- NCT05848167
- Acronym / sponsor ID
- GSKY20210404
- Conditions
- Osteoporotic Fractures
- Keywords
- Senile osteoporotic fracture,Cohort study,mechanism,outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Suzhou Municipal HospitalUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 14 May 2024 (estimated)
- Study completion
- 14 Jul 2024 (estimated)
- First posted
- 8 May 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.
Osteoporotic fracture is one of the main causes of disability and death in elderly patients. Specific disease cohort study is an important basis for accurate prevention and treatment of senile osteoporotic fractures. Investigators plan to collect and manage the baseline and clinical information of more than 2000 elderly patients with osteoporotic fractures after surgery through the platform of special disease collaborative prevention and treatment system and medical record database of Suzhou Municipal Hospital in two years, and carry out short-term and long-term follow-up observation.
Detailed description
Osteoporotic fracture is one of the main causes of disability and death in elderly patients. Compared with patients with no history of fractures, the risk of a second fracture after an initial fracture doubled, with a fatality rate of up to 34.8%. There has been a lot of progress in the diagnosis and treatment of osteoporotic fractures in the elderly. However, there are few reports on the diagnosis and treatment of osteoporotic fractures in the elderly after surgery. Based on previous studies, it is found that the re-fracture after operation of osteoporotic fracture in the elderly is not only directly caused by the fall, but also caused by the interaction of multiple risk factors including environmental factors, physiological factors and neuroskeletal musculoskeletal system. Therefore, it is of great significance to break the traditional diagnosis and treatment mode, improve the diagnosis and treatment effect, and save medical resources to carry out research on the disease characteristics, rules and risk warning after senile osteoporotic fracture operation. Specific disease cohort study is an important basis for accurate prevention and treatment of senile osteoporotic fractures. Investigators plan to collect and manage the baseline and clinical information of more than 2000 elderly patients with osteoporotic fractures after surgery through the platform of special disease collaborative prevention and treatment system and medical record database of Suzhou Municipal Hospital in two years, and carry out short-term and long-term follow-up observation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Elderly patients after operation of osteoporotic fracture.
Key inclusion criteria (3 listed)
- Patients ≥65 years old
- Patients with osteoporosis
- No gender limitation
Key exclusion criteria (4 listed)
- < 65 years old;
- Non-osteoporotic fracture;
- Alzheimer's disease;
- Bone tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone mineral density
Time frame: two years
BMD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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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.
Hao Y feng, doctor study chair
Suzhou Municipal Hospital
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 Osteoporotic Fractures, run by Suzhou Municipal 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?
The sponsor lists 3 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: status not confirmed, as of the sponsor's last update on 22 Nov 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 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?
Contact Hao Y feng, doctor (13913109339, 13913109339@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: two years). 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 22 Nov 2023; AzTrials last refreshed its copy on 27 Oct 2026.