Bone Microstructure by Using HR-pQCT in Long Courses After Gastrectomy

NCT03251430 | Unknown

• 1 other identifier: 17061943
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Sarcopenia; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

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

  volumetric bone mineral density

  day1

Secondary Outcomes (6)

• Comparing bone microstructure with sarcopenia

  day1

• Comparing bone microstructure with serum biomarkers of osteoporosis

  day1

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

  day1

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

  day1

• Comparing bone microstructure with quality of life (BDHQ)

  day1

Study Arms (3)

Control group

38 patients without gastrectomy , who are similar background in other group, are collected from date Pathologic analysis of primary osteoporosis: investigating age and osteoporosis related changes of bone microstructure by using HR-pQCT (UMIN000023535)

Distal Gastrectomy (DG) group

38 patients with distal gastrectomy due to gastric cancer before no more than 5 years

Procedure: gastrectomy

Total Gastrectomy (TG) group

38 patients with distal gastrectomy due to gastric cancer before no more than 5 years

Procedure: gastrectomy

Interventions

gastrectomy PROCEDURE

Distal gastrectomy, Total gastrectomy

Distal Gastrectomy (DG) group; Total Gastrectomy (TG) group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Japanese

You may qualify if:

• At least 5 years have elapsed since 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).

Sponsors & Collaborators

• Kobayashi Shinichiro: lead

Study Sites (1)

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Protein

MeSH Terms

Conditions

Osteoporosis; Sarcopenia; Stomach Neoplasms

Interventions

Gastrectomy

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Shinichiro Kobayashi, MD

  Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shinichiro Kobayashi, MD

CONTACT

81958197316; shinichirokobayashi@nagasaki-u.ac.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator in department of Surgery

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 16, 2017
• Study Start: September 20, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 31, 2019
• Last Updated: January 9, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)