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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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 eff

Detailed Summary:
Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Current Primary Outcome: Correlation between periostin level and cortical porosity [ Time Frame: day 1 ]

Correlation between periostin serum level (ng/ml) and cortical porosity. Cortical porosity (%) is measured by HR-pQCT


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Correlation between periostin level and other trabecular and cortical microarchitectural parameters (composite outcome) [ Time Frame: 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)

  • Correlation between parathyroid hormon level and other trabecular and cortical microarchitectural parameters (composite outcome) [ Time Frame: 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)

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


Original Secondary Outcome:

  • Correlation between periostin level and other trabecular and cortical microarchitectural parameters (composite outcome) [ Time Frame: day 1 ]

    Correlation between periostin serum level (ng/ml) and other trabecular and cortical microarchitectural parameters. and 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)

  • Correlation between parathyroid hormon level and other trabecular and cortical microarchitectural parameters (composite outcome) [ Time Frame: day 1 ]

    Correlation between parathyroid hormon serum level (pg/ml) and other trabecular and cortical microarchitectural parameters. and 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)

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


Information By: Centre Hospitalier Universitaire de Saint Etienne

Dates:
Date Received: August 13, 2015
Date Started: March 2014
Date Completion:
Last Updated: May 24, 2016
Last Verified: May 2016