Primary OsteoporosisNCT02142348
Longitudinal Study of Primary Osteoporosis in Shanghai Postmenopausal Women
An observational study of Primary Osteoporosis, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
To popularize knowledge of prevention and health care of osteoporosis.To investigate the prevalence of primary osteoporosis in community residents. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Primary Osteoporosis
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Dec 2018
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Randomly selected two communities in Xuhui District to investigate.
Who may be able to join
- Had clinical diagnosis of osteoporosis.
- With Bone Mineral Density by dual energy X-ray examination, T value <-2.5 or less.
- Be willing to and be able to join in the study and signed Informed consent.
Who cannot join
- Excluding the impact of endocrine diseases of bone metabolism (gonadal, adrenal, parathyroid and thyroid disease), rheumatoid arthritis and other autoimmune diseases that affect the absorption of calcium and vitamin D and regulation of the digestive tract and kidney disease, multiple myeloma and other malignant diseases, long-term use of corticosteroids or other drugs affecting bone metabolism, and a variety of congenital and acquired diseases of bone metabolism.
- if they were unable to complete the study survey.
Trial locations and contacts
1 site in 1 country.
Xuejun Cui, Dr. contact
China1 site
Longhua Hospital
Shanghai, Shanghai Municipality, 200032
Xuejun Cui, 13917715524@139.com
Chenguang Li, Dr.
About this study
To popularize knowledge of prevention and health care of osteoporosis.To investigate the prevalence of primary osteoporosis in community residents.
Read the detailed description
- Objective:
- To popularize knowledge of prevention and health care of osteoporosis.
- To investigate the prevalence of primary osteoporosis in community residents.
- Method:
- The survey study included the five boroughs of six communities in Shanghai (Xuhui District 2, Pudong New Area 1, Minhang District 1, Pudong New Area 1, Jiading District 1). 10,000 participants are expected to be included.
- Through a questionnaire and physical examination form, carries on the investigation to the 50-85 years old postmenopausal women during the 3-year follow-up period.
- Make a survey of Bone Mineral Density,SF-36,international osteoporosis foundation ONE-MINUTE OSTEOPOROSIS RISK TEST,Markers of bone metabolism test,EQ-5D,Hepatic-renal function test and thyroid stimulating hormone level test.
- Physicians in each community as the backbone, Shanghai University of Traditional Chinese Medicine, Longhua Hospital is responsible for personnel training.
- Shanghai Clinical Research Center is responsible for program and data management.
- Shanghai District Health and Family Planning Commission is responsible for coordinating the organization.
- Conditions
- Primary Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| osteoprosis research | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
Measured: baseline
Secondary outcomes (6)
SF-36
a composite of functional status
Measured: baseline
international osteoporosis foundation ONE-MINUTE OSTEOPOROSIS RISK TEST
Measured: baseline
Markers of bone metabolism test
Fasting peripheral blood collected 2ml.Markers of bone metabolism test，including alkaline phosphatase, 25-hydroxy-vitamin D，prepeptide typeⅠ procollagen，osteocalcin，type I collagen cross-linked C-terminal telopeptide，tartrate resistant acid phosphatase.
Measured: baseline
EQ-5D
A standardised instrument for use as a measure of health outcome.
Measured: baseline
Hepatic-renal function test
Fasting peripheral blood collected 2ml.Hepatic-renal function test，including calcium, phosphorus, creatinine.
Measured: baseline
thyroid stimulating hormone level test
Fasting peripheral blood collected 1ml for thyroid stimulating hormone test.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cui xuejun, Shanghai University of Traditional Chinese Medicine
- Investigators
- Yongjun Wang, Dr, Principal investigator, Study Principal Investigator Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142348
- Sponsor's protocol ID
- Shanghai OP Survey
- Status last verified
- May 2014
- First submitted
- 14 May 2014
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xu H, Zhang H, Aimaiti R, Yuan C, Cai F, Wang H, Ji J, Liang J, Cui J, Wang J, Shu B, Xu H, Liang Q, Shi Q, Sun Q, Fang R, Tang D, Wang Y; China Community-based Cohort of Osteoporosis (CCCO) collaborative group. Early-life malnutrition exposure associated with higher osteoporosis risk in adulthood: a large-scale cross-sectional study. Int J Surg. 2025 Jan 1;111(1):190-199. doi: 10.1097/JS9.0000000000002057.
PubMed 39196877
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Primary Osteoporosis in Shanghai Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02142348
- Acronym / sponsor ID
- Shanghai OP Survey
- Conditions
- Primary Osteoporosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 May 2014 (estimated)
- 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.
To popularize knowledge of prevention and health care of osteoporosis.To investigate the prevalence of primary osteoporosis in community residents.
Detailed description
- Objective:
- To popularize knowledge of prevention and health care of osteoporosis.
- To investigate the prevalence of primary osteoporosis in community residents.
- Method:
- The survey study included the five boroughs of six communities in Shanghai (Xuhui District 2, Pudong New Area 1, Minhang District 1, Pudong New Area 1, Jiading District 1). 10,000 participants are expected to be included.
- Through a questionnaire and physical examination form, carries on the investigation to the 50-85 years old postmenopausal women during the 3-year follow-up period.
- Make a survey of Bone Mineral Density,SF-36,international osteoporosis foundation ONE-MINUTE OSTEOPOROSIS RISK TEST,Markers of bone metabolism test,EQ-5D,Hepatic-renal function test and thyroid stimulating hormone level test.
- Physicians in each community as the backbone, Shanghai University of Traditional Chinese Medicine, Longhua Hospital is responsible for personnel training.
- Shanghai Clinical Research Center is responsible for program and data management.
- Shanghai District Health and Family Planning Commission is responsible for coordinating the organization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| osteoprosis research | – | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Randomly selected two communities in Xuhui District to investigate.
Key inclusion criteria (3 listed)
- Had clinical diagnosis of osteoporosis.
- With Bone Mineral Density by dual energy X-ray examination, T value <-2.5 or less.
- Be willing to and be able to join in the study and signed Informed consent.
Key exclusion criteria (2 listed)
- Excluding the impact of endocrine diseases of bone metabolism (gonadal, adrenal, parathyroid and thyroid disease), rheumatoid arthritis and other autoimmune diseases that affect the absorption of calcium and vitamin D and regulation of the digestive tract and kidney disease, multiple myeloma and other malignant diseases, long-term use of corticosteroids or other drugs affecting bone metabolism, and a variety of congenital and acquired diseases of bone metabolism.
- if they were unable to complete the study survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone Mineral Density
Time frame: baseline
6 secondary outcomes
SF-36
Time frame: baseline
international osteoporosis foundation ONE-MINUTE OSTEOPOROSIS RISK TEST
Time frame: baseline
Markers of bone metabolism test
Time frame: baseline
EQ-5D
Time frame: baseline
Hepatic-renal function test
Time frame: baseline
thyroid stimulating hormone level test
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- Derived from this study: PubMed 39196877Xu H, Zhang H, Aimaiti R, Yuan C, Cai F, Wang H, Ji J, Liang J, Cui J, Wang J, Shu B, Xu H, Liang Q, Shi Q, Sun Q, Fang R, Tang D, Wang Y; China Community-based Cohort of Osteoporosis (CCCO) collaborative group. Early-life malnutrition exposure associated with higher osteoporosis risk in adulthood: a large-scale cross-sectional study. Int J Surg. 2025 Jan 1;111(1):190-199. doi: 10.1097/JS9.0000000000002057.
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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.
Xuejun Cui, Dr. contact
Yongjun Wang, Dr principal investigator
Study Principal Investigator Longhua Hospital
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 Primary Osteoporosis, run by Shanghai University of Traditional Chinese Medicine 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 3 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 20 May 2014. 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 Xuejun Cui, Dr. (13917715524@139.com), 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?
On the ClinicalTrials.gov record for NCT02142348, which also lists 1 linked publication.
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 20 May 2014.