Longitudinal Study of Primary Osteoporosis in Shanghai Po... | NCT02142348

Studies
Longitudinal Study of Primary Osteoporosis in Shanghai Postmenopausal Women

NCT02142348

Sponsor

Shanghai University of Traditional Chinese Medicine

Status

Unknown status

Last Update Posted

May 20, 2014Estimated

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Primary Osteoporosis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

May 14, 2014

First Submission Date that Met QC Criteria

May 15, 2014

First Posted Date

May 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2014

Last Update Posted Date

May 20, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cui xuejun, Vice director, Shanghai University of Traditional Chinese MedicinePrincipal Investigator

Lead Sponsor

Shanghai University of Traditional Chinese MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3,000Estimated

Label	Type	Description	Intervention Names
osteoprosis research

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone Mineral Density		baseline

Secondary Outcomes

Measure	Description	Time Frame
SF-36	a composite of functional status	baseline
international osteoporosis foundation ONE-MINUTE OSTEOPOROSIS RISK TEST		baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Randomly selected two communities in Xuhui District to investigate.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xuejun Cui, Dr.	Contact			13917715524@139.com

Overall Officials

Name	Affiliation	Role
Yongjun Wang, Dr	Study Principal Investigator Longhua Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Longhua Hospital		Shanghai	Shanghai Municipality	200032	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39196877	Derived	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.