HELICOBACTER PYLORI INFECTIONSNCT06818591
Preventive Effect of H.Pylori Eradication on Osteoporosis
An observational study of HELICOBACTER PYLORI INFECTIONS and Osteoporosis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS, Osteoporosis
- What is being tested?
- DEXA(Dual-Energy X-ray Absorptiometry)
- How many people
- 846 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2003to Jun 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients tested Helicobacter pylori status in Seoul National University Bundang Hospital, from 2003 to 2023
Who may be able to join
- ㆍPatients tested Helicobacter pylori status
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: 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.
Read the 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.
- Conditions
- HELICOBACTER PYLORI INFECTIONS, Osteoporosis
- Being tested
- DEXA(Dual-Energy X-ray Absorptiometry)
- Keywords
- Helicobacter pylori eradication, osteoporosis, Sex difference, Age
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXA(Dual-Energy X-ray Absorptiometry)Diagnostic test
Followed for up to 20 years
| Study group | Role | What they receive |
|---|---|---|
| Eradicated group | Helicobacter pylori eradication was successfully achieved. Receives: Diagnostic Test: DEXA(Dual-Energy X-ray Absorptiometry) | |
| Non-eradicated group | Helicobacter pylori eradication was not successfully achieved. Receives: Diagnostic Test: DEXA(Dual-Energy X-ray Absorptiometry) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of new-onset osteoporosis
Measured: The patients were prospectively monitored until they either developed osteoporosis or reached the study endpoint in February 2023, whichever occurred first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study startMay 2003
- Primary completionFeb 2023
- Study completionJun 2023
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 HELICOBACTER PYLORI INFECTIONSStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 846 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818591
- Sponsor's protocol ID
- B-2401-878-002
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim Y, Choi Y, Kim N, Jeon EB, Kong SH, Lee JH, Lee HK, Jun YK, Yoon H, Shin CM, Park YS, Lee DH, Ahn S. Preventive Effect of Helicobacter pylori Eradication on Osteoporosis in Females: A 20-Year Prospective Observational Cohort Study. Gut Liver. 2026 May 15;20(3):385-396. doi: 10.5009/gnl250164. Epub 2025 Aug 18.
PubMed 40820207
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Effect of Helicobacter Pylori Eradication on Osteoporosis in Females: Prospective Observational Cohort Study for Up to 20 Years
- ClinicalTrials.gov ID
- NCT06818591
- Acronym / sponsor ID
- B-2401-878-002
- Conditions
- HELICOBACTER PYLORI INFECTIONS, Osteoporosis
- Keywords
- Helicobacter pylori eradication, osteoporosis, Sex difference, Age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 846 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- May 2003 (actual)
- Primary completion
- Feb 2023 (actual)
- Study completion
- Jun 2023 (actual)
- First posted
- 10 Feb 2025 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eradicated group | – | Diagnostic Test: DEXA(Dual-Energy X-ray Absorptiometry)Helicobacter pylori eradication was successfully achieved. |
| Non-eradicated group | – | Diagnostic Test: DEXA(Dual-Energy X-ray Absorptiometry)Helicobacter pylori eradication was not successfully achieved. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients tested Helicobacter pylori status in Seoul National University Bundang Hospital, from 2003 to 2023
Key inclusion criteria (1 listed)
- ㆍPatients tested Helicobacter pylori status
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEXA(Dual-Energy X-ray Absorptiometry)Followed for up to 20 years | Diagnostic test | Eradicated group, Non-eradicated group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Derived from this study: PubMed 40820207Kim Y, Choi Y, Kim N, Jeon EB, Kong SH, Lee JH, Lee HK, Jun YK, Yoon H, Shin CM, Park YS, Lee DH, Ahn S. Preventive Effect of Helicobacter pylori Eradication on Osteoporosis in Females: A 20-Year Prospective Observational Cohort Study. Gut Liver. 2026 May 15;20(3):385-396. doi: 10.5009/gnl250164. Epub 2025 Aug 18.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 HELICOBACTER PYLORI INFECTIONS and Osteoporosis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Feb 2025. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 NCT06818591, 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 12 Feb 2025.