- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04534166
A Model for Risk Prediction of Fracture in Diabetic Patients With Osteoporosis
August 26, 2020 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
The fracture risk of diabetic patients proves to be higher than those without diabetesdue to thehyperglycemia, usage of diabetes drugs, the changes in insulin levels and excretion, and this risk begins as early as adolescence.Many factors may be related to bone metabolism in patients with diabetes, including demographic data (e.g.
age, height, weight, gender), medical history (e.g.
smoking, drinking, menopause) and examination (e.g.
bone mineral density, blood routine), urine routine).However, most of existing methods are qualitative assessments and do not take the interactions of the physiological factors of humans into consideration.
In addition, the fracture risk of diabetic patients with osteoporosis has not been further studied before.
In order to investigate the effect of patients' physiological factors on fracture risk, in the paper, we used a hybrid model combining XGBoost with deep neural network to predict the fracture risk of diabetic patients with osteoporosis.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Chinese
Description
Inclusion Criteria:
- Patients in Hospital's outpatient and inpatient His database between July 2012 and November 2022, diabetic patients were combined with osteoporosis.
Exclusion Criteria:
- Patients with fractures before diagnosis of diabetes; patients with fractures before diagnosis of osteoporosis; patients with hyroid disease and other diseases that seriously affect bone metabolism.
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 |
Time Frame |
|---|---|
|
Fracture
Time Frame: 2-10 year
|
2-10 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 1, 2012
Primary Completion (Anticipated)
September 30, 2022
Study Completion (Anticipated)
September 30, 2022
Study Registration Dates
First Submitted
August 26, 2020
First Submitted That Met QC Criteria
August 26, 2020
First Posted (Actual)
September 1, 2020
Study Record Updates
Last Update Posted (Actual)
September 1, 2020
Last Update Submitted That Met QC Criteria
August 26, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XH-20-020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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