Type 2 Diabetes Mellitus and Fragility FracturesNCT03456271
A Prospective Cohort Study:Forecast Fracture Risk With a Serum Marker of Type 2 Diabetes in Guangzhou Community
An observational study of Type 2 Diabetes Mellitus and Fragility Fractures, run by Zhujiang Hospital at 5 sites in China.
Trial summary
The objective of this study is to find out the biochemical markers which have independent predictive value of fragility fractures risk with Type 2 diabetes in Guangzhou community and evaluate bone strength better and increase the ability of recognizing fracture risk through following-up visits the bone metabolism… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus and Fragility Fractures
- How many people
- 99 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jul 2017to 31 Dec 2021
- How long will I take part?
- 3 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the participants were recruited from Zhujiang Hospital,Guangzhou No.12 People's Hospital,Haizhu Changgang Community,Baiyun Community Taihe Town and Tianhe Community.
Who may be able to join
- (1) aged 18-65 years; (2) patients were diagnosed with type 2 diabetes based on the definition of diabetes of WHO in 1999.
Who cannot join
- 1. type 1 diabetes and other specific types of diabetes; 2. diabetes related acute complications like diabetic ketoacidosis and hyperglycemic hyperosmolar status. 3. had used drugs that is known to have effect on bone(like active vitamin D, bisphosphonate, calcitonin, estrogen receptor modulators, estrogen, thiazolidinediones); 4. suffer from diseases that is known to have effect on bone (hyperthyroidism, hypothyroidism, hyperparathyroidism, hypoparathyroidism,cushing syndrome,chronic renal failure,renal tubular acidosis,osteoporosis after gastrectomy,osteoporosis caused by liver disease,rheumatoid disease,osteoporosis induced by gastrointestinal absorption dysfunction); 5. disuse osteoporosis; 6. cannot be exposure to sunlight due to skin diseases; 7. use glucocorticoids for over 3 months.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Baiyun Community Taihe Town
Guangzhou, Guangdong, 510000
Guangzhou No.12 People's Hospital
Guangzhou, Guangdong, 510000
Haizhu Changgang Community
Guangzhou, Guangdong, 510000
Tianhe Community
Guangzhou, Guangdong, 510000
Zhujiang Hospital
Guangzhou, Guangdong, 510000
About this study
The objective of this study is to find out the biochemical markers which have independent predictive value of fragility fractures risk with Type 2 diabetes in Guangzhou community and evaluate bone strength better and increase the ability of recognizing fracture risk through following-up visits the bone metabolism index like esRAGE-to-pentosidine ratio of the petients with type 2 diabetes and osteoporosis,compared with the classical fracture risk assessment instrument.
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| fracture group | Not described | |
| non-fracture group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
fracture
the participants happen to fracture
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start1 Jul 2017
- Primary completion30 Nov 2021
- Study completion31 Dec 2021
Why it stopped: limited Patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus and Fragility 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
- 99 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456271
- Sponsor's protocol ID
- 2017-NFMDXK-001
- Status last verified
- Jan 2021
- First submitted
- 28 Feb 2018
- Last updated
- 21 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study:Forecast Fracture Risk With a Serum Marker of Type 2 Diabetes in Guangzhou Community
- ClinicalTrials.gov ID
- NCT03456271
- Acronym / sponsor ID
- 2017-NFMDXK-001
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: limited Patient recruitment
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Mar 2018 (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 objective of this study is to find out the biochemical markers which have independent predictive value of fragility fractures risk with Type 2 diabetes in Guangzhou community and evaluate bone strength better and increase the ability of recognizing fracture risk through following-up visits the bone metabolism index like esRAGE-to-pentosidine ratio of the petients with type 2 diabetes and osteoporosis,compared with the classical fracture risk assessment instrument.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fracture group | – | – |
| non-fracture group | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the participants were recruited from Zhujiang Hospital,Guangzhou No.12 People's Hospital,Haizhu Changgang Community,Baiyun Community Taihe Town and Tianhe Community.
Key inclusion criteria (1 listed)
- (1) aged 18-65 years; (2) patients were diagnosed with type 2 diabetes based on the definition of diabetes of WHO in 1999.
Key exclusion criteria (1 listed)
- 1. type 1 diabetes and other specific types of diabetes; 2. diabetes related acute complications like diabetic ketoacidosis and hyperglycemic hyperosmolar status. 3. had used drugs that is known to have effect on bone(like active vitamin D, bisphosphonate, calcitonin, estrogen receptor modulators, estrogen, thiazolidinediones); 4. suffer from diseases that is known to have effect on bone (hyperthyroidism, hypothyroidism, hyperparathyroidism, hypoparathyroidism,cushing syndrome,chronic renal failure,renal tubular acidosis,osteoporosis after gastrectomy,osteoporosis caused by liver disease,rheumatoid disease,osteoporosis induced by gastrointestinal absorption dysfunction); 5. disuse osteoporosis; 6. cannot be exposure to sunlight due to skin diseases; 7. use glucocorticoids for over 3 months.
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 |
|---|---|---|
| Other | fracture group, non-fracture group |
Primary outcome
fracture
Time frame: 3 years
the participants happen to fracture
Results and safety
The study was stopped early (reason given: limited Patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Fragility Fractures, run by Zhujiang Hospital at 5 sites 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 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: stopped early, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study was stopped early (reason given: limited Patient recruitment). 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: 3 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 21 Mar 2022.