OsteoporosisNCT06915935
Epidemiological Study of Osteoporosis in the Elderly Population of Shandong Province
An observational study of Osteoporosis and Osteoporosis (Senile), run by The Second Hospital of Shandong University at 1 site in China.
Trial summary
At present, there is little epidemiological information on osteoporosis in the elderly population of Shandong Province, especially the lack of systematic research on the role of bone metabolism and biochemical indicators in the diagnosis and prognosis of osteoporosis in the elderly population of Shandong Province. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteoporosis (Senile)
- What is being tested?
- dualenergy X-ray absorptiometry
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: According to the level of economic development, population composition, geographical location, cost-effectiveness and feasibility of the program, a total of 10 regions covering five prefecture-level cities in east, west, south, north and middle of Shandong Province were selected to investigate the community population in Shandong Province from August 1, 2023 to January 31, 2026. The inclusion population was residents ≥65 years of age who had lived in the area for more than 6 months in the past 1 year, and the exclusion criteria were cognitive impairment or mental illness.
Who may be able to join
- Residents ≥65 years of age who had lived in the area for more than 6 months in the past 1 year
Who cannot join
- People with cognitive impairment or mental illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Community/rural health service centres
Jinan, Shandong, 250000
Bin Xu, PHD, +8615069343331, 202236166@mail.sdu.edu.cn
Shiqing Feng, MD
About this study
Official title: Study on the Epidemiological Characteristics of Osteoporosis and the Diagnostic Significance of Bone Metabolic Biochemical Markers in the Elderly Population of Shandong Province
At present, there is little epidemiological information on osteoporosis in the elderly population of Shandong Province, especially the lack of systematic research on the role of bone metabolism and biochemical indicators in the diagnosis and prognosis of osteoporosis in the elderly population of Shandong Province. The group intends to conduct a study on the epidemiological characteristics of osteoporosis patients and the significance of bone metabolism biochemical indexes in the diagnosis and prognosis of osteoporosis in elderly people in Shandong Province, which includes 1) assessing the prevalence of osteoporosis and the risk factors associated with osteoporosis in the community population, and 2) exploring the role of bone metabolism biochemical indexes in the diagnosis and prognosis of osteoporosis in the hospitalised population. Expected outcomes include the establishment of a database of community and inpatient populations in Shandong Province, publication of research papers, and participation in academic conferences at home and abroad. The database will collect and organise data on osteoporosis in the community and inpatient osteoporosis in Shandong Province, and provide support for subsequent data analysis and research.
- Conditions
- Osteoporosis, Osteoporosis (Senile)
- Being tested
- dualenergy X-ray absorptiometry
- Keywords
- osteoporosis, epidemiology, elderly, Biochemical indexes of bone metabolism
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dualenergy X-ray absorptiometryRadiation
Dual-energy X-ray Absorptiometry (DXA) is an accurate, safe, and rapid bone mineral density measurement method that is widely used in the diagnosis of osteoporosis and the assessment of fracture risk. The principle is based on the difference in absorption of different energy X-rays in bone and soft tissue, and bone mineral content (BMC) and bone mineral density (BMD) are obtained through mathematical calculations. DXA is commonly used to measure bone mineral density in the lumbar spine, femoral neck, and forearm, and to assess the degree of osteoporosis using a T score, where T ≤ -2.5 is defined as osteoporosis. Due to the advantages of high precision, low radiation dose and convenient operation, DXA is considered as the gold standard for clinical bone mineral density detection.
| Study group | Role | What they receive |
|---|---|---|
| osteoporosis | Based on the economic development level, population composition, geographical location, cost-effectiveness and feasibility of the program, a cross-sectional survey was conducted to investigate the community population in Shandong Province from August 1, 2023 to January 31, 2026, covering cities and rural areas in the east, west, south, north and middle prefecture-level cities in 10 regions. The inclusion population was residents ≥65 years of age who had lived in the area for more than 6 months in the past 1 year, and the exclusion criteria were cognitive impairment or mental illness. Receives: Radiation: dualenergy X-ray absorptiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Bone Mineral Density (BMD) refers to the mineral content per unit area or unit volume of bone tissue, usually expressed in g/cm², and is an important indicator to measure bone strength and assess the risk of osteoporosis.
Measured: baseline
Secondary outcomes (2)
Numerical Rating Scale
The patient's pain intensity is evaluated by Numerical Rating Scale. Patients are required to select a number to represent the pain intensity according to their own feelings within the numerical range of 0 to 10, in which 0 represents no pain and 10 represents extremely severe pain.
Measured: baseline
Grip strength test
Grip strength examination is a common method to evaluate hand muscle strength and overall muscle strength, which is widely used in rehabilitation assessment, nutritional status judgment and health monitoring of the elderly.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start1 Aug 2023
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915935
- Sponsor's protocol ID
- KYLL2024022
- Status last verified
- Apr 2025
- First submitted
- 28 Mar 2025
- Last updated
- 8 Apr 2025
- 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 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Epidemiological Characteristics of Osteoporosis and the Diagnostic Significance of Bone Metabolic Biochemical Markers in the Elderly Population of Shandong Province
- ClinicalTrials.gov ID
- NCT06915935
- Acronym / sponsor ID
- KYLL2024022
- Conditions
- Osteoporosis, Osteoporosis (Senile)
- Keywords
- osteoporosis, epidemiology, elderly, Biochemical indexes of bone metabolism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 8 Apr 2025 (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.
At present, there is little epidemiological information on osteoporosis in the elderly population of Shandong Province, especially the lack of systematic research on the role of bone metabolism and biochemical indicators in the diagnosis and prognosis of osteoporosis in the elderly population of Shandong Province. The group intends to conduct a study on the epidemiological characteristics of osteoporosis patients and the significance of bone metabolism biochemical indexes in the diagnosis and prognosis of osteoporosis in elderly people in Shandong Province, which includes 1) assessing the prevalence of osteoporosis and the risk factors associated with osteoporosis in the community population, and 2) exploring the role of bone metabolism biochemical indexes in the diagnosis and prognosis of osteoporosis in the hospitalised population. Expected outcomes include the establishment of a database of community and inpatient populations in Shandong Province, publication of research papers, and participation in academic conferences at home and abroad. The database will collect and organise data on osteoporosis in the community and inpatient osteoporosis in Shandong Province, and provide support for subsequent data analysis and research.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| osteoporosis | – | Radiation: dualenergy X-ray absorptiometryBased on the economic development level, population composition, geographical location, cost-effectiveness and feasibility of the program, a cross-sectional survey was conducted to investigate the community population in Shandong Province from August 1, 2023 to January 31, 2026, covering cities and rural areas in the east, west, south, north and middle prefecture-level cities in 10 regions. The inclusion population was residents ≥65 years of age who had lived in the area for more than 6 months in the past 1 year, and the exclusion criteria were cognitive impairment or mental illness. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- According to the level of economic development, population composition, geographical location, cost-effectiveness and feasibility of the program, a total of 10 regions covering five prefecture-level cities in east, west, south, north and middle of Shandong Province were selected to investigate the community population in Shandong Province from August 1, 2023 to January 31, 2026. The inclusion population was residents ≥65 years of age who had lived in the area for more than 6 months in the past 1 year, and the exclusion criteria were cognitive impairment or mental illness.
Key inclusion criteria (1 listed)
- Residents ≥65 years of age who had lived in the area for more than 6 months in the past 1 year
Key exclusion criteria (1 listed)
- People with cognitive impairment or mental illness
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 |
|---|---|---|
| dualenergy X-ray absorptiometryDual-energy X-ray Absorptiometry (DXA) is an accurate, safe, and rapid bone mineral density measurement method that is widely used in the diagnosis of osteoporosis and the assessment of fracture risk. The principle is based on the difference in absorption of different energy X-rays in bone and soft tissue, and bone mineral content (BMC) and bone mineral density (BMD) are obtained through mathematical calculations. DXA is commonly used to measure bone mineral density in the lumbar spine, femoral neck, and forearm, and to assess the degree of osteoporosis using a T score, where T ≤ -2.5 is defined as osteoporosis. Due to the advantages of high precision, low radiation dose and convenient operation, DXA is considered as the gold standard for clinical bone mineral density detection. | Radiation | osteoporosis |
Primary outcome
Bone mineral density
Time frame: baseline
Bone Mineral Density (BMD) refers to the mineral content per unit area or unit volume of bone tissue, usually expressed in g/cm², and is an important indicator to measure bone strength and assess the risk of osteoporosis.
2 secondary outcomes
Numerical Rating Scale
Time frame: baseline
Grip strength test
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Osteoporosis (Senile), run by The Second Hospital of Shandong University 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 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: looking for participants now, as of the sponsor's last update on 8 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Xu, PHD (+8615069343331, 202236166@mail.sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: baseline). 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 Apr 2025.