Healthcare; Risk Prediction; Diabetic Patients With OsteoporosisNCT04534166
A Model for Risk Prediction of Fracture in Diabetic Patients With Osteoporosis
An observational study of Healthcare; Risk Prediction; Diabetic Patients With Osteoporosis, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthcare; Risk Prediction; Diabetic Patients With Osteoporosis
- What is being tested?
- Risk Prediction of Fracture in Diabetic Patients with Osteoporosis
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- 1 Jul 2012to 30 Sep 2022
- How long will I take part?
- 10 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chinese
Who may be able to join
- Patients in Hospital's outpatient and inpatient His database between July 2012 and November 2022, diabetic patients were combined with osteoporosis.
Who cannot join
- 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.
About this study
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.
- Being tested
- Risk Prediction of Fracture in Diabetic Patients with Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Prediction of Fracture in Diabetic Patients with OsteoporosisOther
Risk Prediction of Fracture in Diabetic Patients with Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture
Measured: 2-10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start1 Jul 2012
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthcare; Risk Prediction; Diabetic Patients With OsteoporosisStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Ecologic or community
- Time perspective
- Other
- Target duration
- 10 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534166
- Sponsor's protocol ID
- XH-20-020
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2020
- Last updated
- 1 Sep 2020
- Results posted
- 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 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Model for Risk Prediction of Fracture in Diabetic Patients With Osteoporosis
- ClinicalTrials.gov ID
- NCT04534166
- Acronym / sponsor ID
- XH-20-020
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 1 Sep 2020 (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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese
Key inclusion criteria (1 listed)
- Patients in Hospital's outpatient and inpatient His database between July 2012 and November 2022, diabetic patients were combined with osteoporosis.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Risk Prediction of Fracture in Diabetic Patients with OsteoporosisRisk Prediction of Fracture in Diabetic Patients with Osteoporosis | Other | – |
Primary outcome
Fracture
Time frame: 2-10 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthcare; Risk Prediction; Diabetic Patients With Osteoporosis, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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 1 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 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Fracture (time frame: 2-10 year). 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 1 Sep 2020.