- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05848167
Senile Osteoporotic Fractures Cohort Study(SOFCS)
November 20, 2023 updated by: Mo Zhou, Suzhou Municipal Hospital
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hao Y feng, doctor
- Phone Number: 13913109339
- Email: 13913109339@163.com
Study Contact Backup
- Name: Che Y jun, doctor
- Phone Number: 19941919699
- Email: cheyanjun1980@hotmail.com
Study Locations
-
-
Jiangsu
-
Suzhou, Jiangsu, China, 215000
- Recruiting
- Suzhou Municipal Hospital
-
Contact:
- Hao Y feng, doctor
- Phone Number: 13913109339
- Email: 13913109339@163.com
-
Contact:
- Che Y jun, doctor
- Phone Number: 19941919699
- Email: cheyanjun1980@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Elderly patients after operation of osteoporotic fracture.
Description
Inclusion Criteria:
- Patients ≥65 years old
- Patients with osteoporosis
- No gender limitation
Exclusion Criteria:
- < 65 years old;
- Non-osteoporotic fracture;
- Alzheimer's disease;
- Bone tumors.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone mineral density
Time Frame: two years
|
BMD
|
two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Hao Y feng, doctor, Suzhou Municipal Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2021
Primary Completion (Estimated)
May 14, 2024
Study Completion (Estimated)
July 14, 2024
Study Registration Dates
First Submitted
April 26, 2023
First Submitted That Met QC Criteria
May 5, 2023
First Posted (Actual)
May 8, 2023
Study Record Updates
Last Update Posted (Actual)
November 22, 2023
Last Update Submitted That Met QC Criteria
November 20, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GSKY20210404
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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