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Association Between Serum Periostin Levels and Cortical Porosity in Patients With Secondary Hyperparathyroidism

Based on the evidence that periostin is specifically involved in intra-cortical remodeling control, our working hypothesis is that assessment of its concentration in the serum would be helpful in identifying patients with severe cortical porosity, a critical parameter in bone fragility. Periostin expression by osteoblasts and osteocytes is part of the bone cortical response to anabolic stimuli such as mechanical strain or intermittent increase in parathyroid hormone. However, it remains unknown whether this expression may participate as well to mechanisms that will lead to exaggerated intra-cortical remodeling and subsequent bone loss.

In rare clinical situations in which trans-iliac bone biopsies will be necessary to better understand their bone status in addition to densitometry and biological bone markers assessment, specific analyses using immune-staining techniques will be performed on the bone sample. Data from routine follow-up every six months will be also collected in this specific sub-group.

High resolution peripheral quantitative computerized tomography (HR-pQCT) gives the opportunity of performing a virtual bone biopsy providing information on trabecular and cortical microarchitecture in vivo. These microarchitectural parameters allow a more accurate evaluation of the alteration of the bone structure and therefore of the fracture risk as compared to current tools used in clinical practice such as densitometry. However, the availability of such HRpQCT facilities is limited and there is on-going development on the best way of measuring porosity for example. The definition of a biological profile including key proteins such as periostin and sclerostin involved in porosity mechanisms is therefore of great interest. A better understanding of the relationship between bone matrix components and parathyroid hormone effects also appears as critical. Follow-up of routine evaluation parameters reflecting bone status in a subgroup of specific patients could also provide new and additional information.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

22

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Saint-etienne, Frankrig, 42000
        • CHU de Saint-Etienne

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Hyperparathyroidism defined by a parathyroid hormone serum level above 65 ng/ml, secondary to Chronic Kidney Disease (CKD) ou vitamin D deficiency

Exclusion Criteria:

  • Concurrent bone disease (such as Paget's disease, osteomalacia),
  • Other endocrinopathy having an impact on bone metabolism (such as Cushing, hyperthyroidism, severe hypogonadism (except menopause)),
  • Current or previous bisphosphonate treatment.
  • Transplantation
  • parathyroidectomy
  • Life expectancy less than 3 months.
  • Lack of study understanding.
  • Lack of agreement.
  • Under legal control.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: secondary hyperparathyroidism
Blood specimen and HR-pQCT for measure bone quality and quantity
blodprøve
The Xtrem CT scanco device is a HR-pQCT used for 3D bone measurements at the tibia and the radius levels in humans
Andre navne:
  • Xtrem CT scanco

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation between periostin level and cortical porosity
Tidsramme: day 1
Correlation between periostin serum level (ng/ml) and cortical porosity. Cortical porosity (%) is measured by HR-pQCT
day 1

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation between periostin level and other trabecular and cortical microarchitectural parameters (composite outcome)
Tidsramme: day 1

Correlation between periostin serum level (ng/ml) and other trabecular and cortical microarchitectural parameters. Cortical microarchitectural parameters are a composite measure measured by HR-pQCT. The measures are : Total volumetric mineral density (mg/ccm HA), Trabecular volumetric mineral density (mg/ccm HA), Cortical volumetric mineral density (mg/ccm HA), Number of bone trabeculae (1/mm), Trabecular thickness (mm), Cortical thickness (mm), Trabecular spacing (mm)

o Trabecular distribution (mm)

day 1
Correlation between parathyroid hormon level and other trabecular and cortical microarchitectural parameters (composite outcome)
Tidsramme: day 1

Correlation between parathyroid hormon serum level (pg/ml) and other trabecular and cortical microarchitectural parameters. Cortical microarchitectural parameters are a composite measure measured by HR-pQCT. The measures are : Total volumetric mineral density (mg/ccm HA), Trabecular volumetric mineral density (mg/ccm HA), Cortical volumetric mineral density (mg/ccm HA), Number of bone trabeculae (1/mm), Trabecular thickness (mm), Cortical thickness (mm), Trabecular spacing (mm)

o Trabecular distribution (mm)

day 1
Correlation between Sclerostin serum level and cortical porosity
Tidsramme: Day 1
Correlation between Sclerostin serum level (ng/ml) and cortical porosity.Cortical porosity (%) is measured by HR-pQCT.
Day 1
Correlation between parathyroid hormon level and cortical porosity
Tidsramme: Day 1
Correlation between parathyroid hormon serum level (pg/ml) and cortical porosity.Cortical porosity (%) is measured by HR-pQCT.
Day 1

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Thierry THOMAS, MD PhD, CHU de Saint-Etienne

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2014

Primær færdiggørelse (Faktiske)

1. april 2016

Studieafslutning (Faktiske)

1. april 2016

Datoer for studieregistrering

Først indsendt

13. august 2015

Først indsendt, der opfyldte QC-kriterier

13. august 2015

Først opslået (Skøn)

14. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. maj 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. maj 2016

Sidst verificeret

1. maj 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 1308046
  • 130560B-22 (Anden identifikator: ANSM)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med blodprøve

3
Abonner