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RecruitingNCT06915935Updated Apr 8, 2025

Epidemiological Study of Osteoporosis in the Elderly Population of Shandong Province

An observational study in Osteoporosis and Osteoporosis (Senile), sponsored by The Second Hospital of Shandong University. Recruiting at 1 site in China. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-08.

Sponsored by The Second Hospital of Shandong University · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 3 months later.
Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
2,000
Ages
65 Years and older
Sex
All
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Study 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. 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.

02

Conditions studied

  • Osteoporosis
  • Osteoporosis (Senile)

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Keywords

  • osteoporosis
  • epidemiology
  • elderly
  • Biochemical indexes of bone metabolism
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In context

Osteoporosis

1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 160 across 455 observational studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

The Second Hospital of Shandong University is the lead sponsor of 35 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Residents ≥65 years of age who had lived in the area for more than 6 months in the past 1 year

Exclusion criteria

Exclusion Criteria:

  • People with cognitive impairment or mental illness
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Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
2,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Radiation: dualenergy X-ray absorptiometry

Interventions

  • Radiationdualenergy X-ray absorptiometry

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline

Secondary outcomes

  1. 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.

    Time frame: baseline

  2. 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.

    Time frame: baseline

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Study locations

1 of 1 sites recruiting
  • Community/rural health service centres
    Jinan, Shandong 250000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2023 (actual). Primary completion is estimated for Jan 2026, 29 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2025
First posted
Apr 8, 2025
StartActual
Aug 1, 2023
Primary completionEst.
Jan 31, 2026
CompletionEst.
Jan 31, 2026
Last update
Apr 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06915935
Lead sponsor
The Second Hospital of Shandong University
Responsible party
Sponsor
First posted
Apr 8, 2025
Start date
Aug 1, 2023
Primary completion
Jan 31, 2026 (estimated)
Completion
Jan 31, 2026 (estimated)
Last update
Apr 8, 2025

Study contacts

Bin Xu, PHD
Contact
202236166@mail.sdu.edu.cn
+8615069343331

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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