NCT02142348

Brief Summary

To popularize knowledge of prevention and health care of osteoporosis.To investigate the prevalence of primary osteoporosis in community residents.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 20, 2014

Status Verified

May 1, 2014

Enrollment Period

3.5 years

First QC Date

May 14, 2014

Last Update Submit

May 15, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Bone Mineral Density

    baseline

Secondary Outcomes (6)

  • SF-36

    baseline

  • international osteoporosis foundation ONE-MINUTE OSTEOPOROSIS RISK TEST

    baseline

  • Markers of bone metabolism test

    baseline

  • EQ-5D

    baseline

  • Hepatic-renal function test

    baseline

  • +1 more secondary outcomes

Study Arms (1)

osteoprosis research

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Randomly selected two communities in Xuhui District to investigate.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Longhua Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Basal whole blood is collected for serum and DNA extraction.

Study Officials

  • Yongjun Wang, Dr

    Study Principal Investigator Longhua Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuejun Cui, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice director

Study Record Dates

First Submitted

May 14, 2014

First Posted

May 20, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

May 20, 2014

Record last verified: 2014-05

Locations