NCT03398226

Brief Summary

Osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after gastrectomy. The aim of the present study was to evaluate osteoporosis by using high-resolution peripheral quantitative computed tomography (HR-pQCT) in the long course after gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years should have elapsed since gastrectomy.

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
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

September 18, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

2.5 years

First QC Date

September 17, 2017

Last Update Submit

January 12, 2018

Conditions

OsteoporosisSarcopeniaGastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Comparing bone microstructure in control, DG, and TG groups

    volumetric bone mineral density loss comparing with before the treatments

    2 years after the treatments

Secondary Outcomes (6)

  • Comparing bone microstructure with sarcopenia

    Before the treatments and 1 and 2 years after the treatments

  • Comparing bone microstructure with serum biomarkers of osteoporosis

    Before the treatments and 1 and 2 years after the treatments

  • Comparing bone microstructure with dual-energy X-ray absorptiometry

    Before the treatments and 1 and 2 years after the treatments

  • Comparing bone microstructure with quality of life (QOL-C30)

    Before the treatments and 1 and 2 years after the treatments

  • Comparing bone microstructure with quality of life (BDHQ)

    Before the treatments and 1 and 2 years after the treatments

  • +1 more secondary outcomes

Study Arms (3)

Control group

Distal Gastrectomy (DG) group

38 patients planing distal gastrectomy due to gastric cancer

Total Gastrectomy (TG) group

38 patients planing total gastrectomy due to gastric cancer

Eligibility Criteria

Age60 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Japanese

You may qualify if:

  • Planning ESD, DG, or TG due to gastric cancer
  • Provide signed informed consent

You may not qualify if:

  • pregnancy
  • Current use of the following osteoporosis agents; Teriparatide, Denosumab, and bisphosphonate
  • Hyperthyroidism
  • Hyperparathyroidism
  • Present malignancy (except in situ carcinoma)
  • Any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy
  • Other diseases which affect bone metabolism
  • Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
  • Received \> 3 months (or equivalent) of osteoporosis treatment
  • Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

RECRUITING

MeSH Terms

Conditions

OsteoporosisSarcopeniaStomach Neoplasms

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Shinichiro Kobayashi, MD

CONTACT

958197316shinichirokobayashi@nagasaki-u.ac.jp

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator in department of Surgery

Study Record Dates

First Submitted

September 17, 2017

First Posted

January 12, 2018

Study Start

September 18, 2017

Primary Completion

March 31, 2020

Study Completion

March 31, 2023

Last Updated

January 17, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)