OsteoporosisNCT06299865
Comparison of Detection Rates Between Two Commonly Used Bone Density Measurement Methods
An observational study of Osteoporosis and Diagnosis, run by Xiaoqian Zhang at 1 site in China.
Trial summary
72 adult patients who underwent lumbar spine anteroposterior DXA and QCT examinations at Qianfoshan Hospital in Shandong Province from January 2019 to December 2022 were selected, with an interval of no more than 3 months between the two examinations for the same patient. 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis, Diagnosis, Dual Energy X-ray Absorptiometry
- What is being tested?
- Ungrouped
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 72 adult patients who underwent lumbar spine anteroposterior DXA and QCT examinations at Qianfoshan Hospital in Shandong Province from January 2019 to December 2022 were selected, with an interval of no more than 3 months between the two examinations for the same patient.
Who may be able to join
- Adults aged 18 and above, regardless of gender
- The interval between DXA and QCT examinations shall not exceed 3 months.
Who cannot join
- Individuals with other metabolic and bone diseases causing focal bone destruction of the vertebral body
- Incomplete key information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Detection Rates of Osteoporosis Between Dual Energy X-ray and Quantitative CT
72 adult patients who underwent lumbar spine anteroposterior DXA and QCT examinations at Qianfoshan Hospital in Shandong Province from January 2019 to December 2022 were selected, with an interval of no more than 3 months between the two examinations for the same patient.
- Record the patient's age, gender, height, and weight; Review the patient's past medical history (especially whether there is a history of brittle fractures, whether there is a history of using drugs that affect bone metabolism, etc.).
- Retrieve the bone density values of the anterior lumbar vertebrae 1 to 4 measured by GE Healthcare Lunar Prodigy dual energy X-ray absorptiometry from the database, and take the average (DXA bone density value). According to the diagnostic criteria of the Diagnosis and Treatment Guidelines for Primary Osteoporosis (2022), determine whether the patient has normal bone mass, decreased bone mass, or osteoporosis.
- Identify the lumbar spine bone density values (QCT bone density values) measured by the GE Gemstone CTHD750 CT instrument from the database. According to the diagnostic criteria of the Chinese Quantitative CT (QCT) Diagnosis Guidelines for Osteoporosis (2018), determine whether the patient has normal bone mass, decreased bone mass, or osteoporosis.
- Statistical analysis was conducted on the normal bone density, bone loss, and number of osteoporosis diagnosed by DXA and QCT respectively, in order to explore the differences in the detection rates of osteoporosis between these two monitoring methods. The data was analyzed and processed using SPSS 21.0 statistical software, and the count data was expressed as a rate (%) χ 2-test, P<0.05 indicates statistically significant difference; Explore whether the difference in detection rates between the two is related to factors such as weight; Calculate the detection rates of osteoporosis using two detection methods in patients who have experienced brittle fractures, and preliminarily determine which detection method is more accurate in determining osteoporosis.
- Conditions
- Osteoporosis, Diagnosis, Dual Energy X-ray Absorptiometry, Quantitative Computed Tomography
- Being tested
- Ungrouped
- Medical subject headings
- Osteoporosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UngroupedOther
Ungrouped
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the difference in detection rates of osteoporosis between dual energy X-ray and quantitative CT
Statistical analysis was conducted on the normal bone density, bone loss, and number of osteoporosis diagnosed by DXA and QCT respectively, in order to explore the differences in the detection rates of osteoporosis between these two monitoring methods. The data was analyzed and processed using SPSS 21.0 statistical software, and the count data was expressed as a rate (%) χ 2-test, P<0.05 indicates statistically significant difference; Explore whether the difference in detection rates between the two is related to factors such as weight; Calculate the detection rates of osteoporosis using two detection methods in patients who have experienced brittle fractures, and preliminarily determine which detection method is more accurate in determining osteoporosis.
Measured: January 2019 to December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaoqian Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaoqian Zhang, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299865
- Sponsor's protocol ID
- YXLL-KY-2023（150）
- Status last verified
- Mar 2024
- First submitted
- 4 Jan 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Detection Rates of Osteoporosis Between Dual Energy X-ray and Quantitative CT
- ClinicalTrials.gov ID
- NCT06299865
- Acronym / sponsor ID
- YXLL-KY-2023（150）
- Conditions
- Osteoporosis, Diagnosis, Dual Energy X-ray Absorptiometry, Quantitative Computed Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Xiaoqian ZhangUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Mar 2024 (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.
72 adult patients who underwent lumbar spine anteroposterior DXA and QCT examinations at Qianfoshan Hospital in Shandong Province from January 2019 to December 2022 were selected, with an interval of no more than 3 months between the two examinations for the same patient.
- Record the patient's age, gender, height, and weight; Review the patient's past medical history (especially whether there is a history of brittle fractures, whether there is a history of using drugs that affect bone metabolism, etc.).
- Retrieve the bone density values of the anterior lumbar vertebrae 1 to 4 measured by GE Healthcare Lunar Prodigy dual energy X-ray absorptiometry from the database, and take the average (DXA bone density value). According to the diagnostic criteria of the Diagnosis and Treatment Guidelines for Primary Osteoporosis (2022), determine whether the patient has normal bone mass, decreased bone mass, or osteoporosis.
- Identify the lumbar spine bone density values (QCT bone density values) measured by the GE Gemstone CTHD750 CT instrument from the database. According to the diagnostic criteria of the Chinese Quantitative CT (QCT) Diagnosis Guidelines for Osteoporosis (2018), determine whether the patient has normal bone mass, decreased bone mass, or osteoporosis.
- Statistical analysis was conducted on the normal bone density, bone loss, and number of osteoporosis diagnosed by DXA and QCT respectively, in order to explore the differences in the detection rates of osteoporosis between these two monitoring methods. The data was analyzed and processed using SPSS 21.0 statistical software, and the count data was expressed as a rate (%) χ 2-test, P<0.05 indicates statistically significant difference; Explore whether the difference in detection rates between the two is related to factors such as weight; Calculate the detection rates of osteoporosis using two detection methods in patients who have experienced brittle fractures, and preliminarily determine which detection method is more accurate in determining osteoporosis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 72 adult patients who underwent lumbar spine anteroposterior DXA and QCT examinations at Qianfoshan Hospital in Shandong Province from January 2019 to December 2022 were selected, with an interval of no more than 3 months between the two examinations for the same patient.
Key inclusion criteria (2 listed)
- Adults aged 18 and above, regardless of gender
- The interval between DXA and QCT examinations shall not exceed 3 months.
Key exclusion criteria (2 listed)
- Individuals with other metabolic and bone diseases causing focal bone destruction of the vertebral body
- Incomplete key information
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 |
|---|---|---|
| UngroupedUngrouped | Other | – |
Primary outcome
Comparison of the difference in detection rates of osteoporosis between dual energy X-ray and quantitative CT
Time frame: January 2019 to December 2022
Statistical analysis was conducted on the normal bone density, bone loss, and number of osteoporosis diagnosed by DXA and QCT respectively, in order to explore the differences in the detection rates of osteoporosis between these two monitoring methods. The data was analyzed and processed using SPSS 21.0 statistical software, and the count data was expressed as a rate (%) χ 2-test, P<0.05 indicates statistically significant difference; Explore whether the difference in detection rates between the two is related to factors such as weight; Calculate the detection rates of osteoporosis using two detection methods in patients who have experienced brittle fractures, and preliminarily determine which detection method is more accurate in determining osteoporosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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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.
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 Osteoporosis and Diagnosis, run by Xiaoqian Zhang 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 2 inclusion and 2 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 8 Mar 2024. 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 Xiaoqian Zhang, doctorate (18553108635, zhxqqy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the difference in detection rates of osteoporosis between dual energy X-ray and quantitative CT (time frame: January 2019 to December 2022). 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 8 Mar 2024.