Preventive Effect of H.pylori Eradication on Osteoporosis

February 8, 2025 updated by: Nayoung Kim, Seoul National University Bundang Hospital

Preventive Effect of Helicobacter Pylori Eradication on Osteoporosis in Females: Prospective Observational Cohort Study for Up to 20 Years

In this study, the investigators observed the long-term incidence rate of osteoporosis in patients who received Helicobacter pylori eradication and examined differences by age and sex.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, the investigators observed the long-term incidence rate of osteoporosis in patients who received Helicobacter pylori eradication and examined differences by age and sex. In addition, the investigators will analyze the correlation between the incidence of osteoporosis by comparing confounding factors such as body mass index, steroid use, and proton pump inhibitor use as well as the eradication status of H. pylori.

Study Type

Observational

Enrollment (Actual)

846

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients tested Helicobacter pylori status in Seoul National University Bundang Hospital, from 2003 to 2023

Description

Inclusion Criteria:

ㆍPatients tested Helicobacter pylori status

Exclusion Criteria:

ㆍPatients aged < 20 years ㆍPatients with unknown Helicobacter pylori bone density status ㆍPatients with with a history of gastric cancer ㆍPatients with prior Helicobacter pylori eradication therapy ㆍPatients with a history of osteoporosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Eradicated group
Helicobacter pylori eradication was successfully achieved.
Diagnostic test: DEXA(Dual-Energy X-ray Absorptiometry)
Followed for up to 20 years
Non-eradicated group
Helicobacter pylori eradication was not successfully achieved.
Diagnostic test: DEXA(Dual-Energy X-ray Absorptiometry)
Followed for up to 20 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the incidence of new-onset osteoporosis
Time Frame: The patients were prospectively monitored until they either developed osteoporosis or reached the study endpoint in February 2023, whichever occurred first.
The patients were prospectively monitored until they either developed osteoporosis or reached the study endpoint in February 2023, whichever occurred first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2003

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 8, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2401-878-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoporosis

Clinical Trials on DEXA(Dual-Energy X-ray Absorptiometry)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe