Bone Microstructure After Gastrectomy Evaluating by Using HR-pQCT
12. januar 2018 oppdatert av: Kobayashi Shinichiro, Nagasaki University
Chronological Change of Bone Microstructure After Gastrectomy
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.
Studieoversikt
Status
Rekruttering
Forhold
Detaljert beskrivelse
The patients after gastrectomy loss appetite and decrease the weight.
Total gastrectomy especially cause severe sarcopenia and metabolic change.
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 primary tools for assessing volumetric density and bone structure are quantitative computed tomography (QCT) and more recently, high-resolution peripheral quantitative computed tomography (HR-pQCT).
However the validation of osteoporosis with HR-pQCT before and after gastrectomy remain elusive.
The aim of the present study was to evaluate osteoporosis by using HR-pQCT before and after after endoscopic resection, distal gastrectomy, and total gastrectomy in the patients with gastric cancer.
Studietype
Observasjonsmessig
Registrering (Forventet)
42
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Shinichiro Kobayashi, MD
- Telefonnummer: 958197316
- E-post: shinichirokobayashi@nagasaki-u.ac.jp
Studiesteder
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Nagasaki, Japan, 852-8501
- Rekruttering
- Nagasaki University Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
60 år til 79 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Japanese
Beskrivelse
Inclusion Criteria:
- Planning ESD, DG, or TG due to gastric cancer
- Provide signed informed consent
Exclusion Criteria:
- 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).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
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Kontrollgruppe
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Distal Gastrectomy (DG) group
38 patients planing distal gastrectomy due to gastric cancer
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Total Gastrectomy (TG) group
38 patients planing total gastrectomy due to gastric cancer
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Comparing bone microstructure in control, DG, and TG groups
Tidsramme: 2 years after the treatments
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volumetric bone mineral density loss comparing with before the treatments
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2 years after the treatments
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Comparing bone microstructure with sarcopenia
Tidsramme: Before the treatments and 1 and 2 years after the treatments
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Correlation between bone mineral density in HR-pQCT and cross-sectional area of the abdominal psoas major muscle
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Before the treatments and 1 and 2 years after the treatments
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Comparing bone microstructure with serum biomarkers of osteoporosis
Tidsramme: Before the treatments and 1 and 2 years after the treatments
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Correlation between bone mineral density in HR-pQCT and biomarkers (25-hydroxyvitaminD, calcium, iPTH, P1NP, ICTP, TRACP5b)
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Before the treatments and 1 and 2 years after the treatments
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Comparing bone microstructure with dual-energy X-ray absorptiometry
Tidsramme: Before the treatments and 1 and 2 years after the treatments
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Correlation of bone mineral density between HR-pQCT and DXA
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Before the treatments and 1 and 2 years after the treatments
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Comparing bone microstructure with quality of life (QOL-C30)
Tidsramme: Before the treatments and 1 and 2 years after the treatments
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Patients will be asked to complete a short debriefing questionnaire covering questions.(QOL-C30).
We compared the average sore about Valid and reliable 30-item questionnaire assessing health related quality of life (6 functional, 9 symptom) before and after treatments.
The score about QOL-C30 is evaluated on a four level scale without Global quality of life.
Global quality of life is evaluated on a seven level scale.
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Before the treatments and 1 and 2 years after the treatments
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Comparing bone microstructure with quality of life (BDHQ)
Tidsramme: Before the treatments and 1 and 2 years after the treatments
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Patients will be asked to complete a short debriefing questionnaire covering questions (BDHQ) B-DHQ is 58-item fixed-portion-type questionnaire The score about BDHQ is evaluated on a seven level scale.
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Before the treatments and 1 and 2 years after the treatments
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Comparing bone microstructure with quality of life (FRAX)
Tidsramme: Before the treatments and 1 and 2 years after the treatments
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Patients will be asked to complete a short debriefing questionnaire covering questions (FRAX).
FRAX score is 12. FRAX is 12-item fixed-portion-type questionnaire.
The score about FRAX is evaluated on a two level scale.
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Before the treatments and 1 and 2 years after the treatments
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. september 2017
Primær fullføring (Forventet)
31. mars 2020
Studiet fullført (Forventet)
31. mars 2023
Datoer for studieregistrering
Først innsendt
17. september 2017
Først innsendt som oppfylte QC-kriteriene
7. januar 2018
Først lagt ut (Faktiske)
12. januar 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. januar 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. januar 2018
Sist bekreftet
1. januar 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 17082126
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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