Skip to main content
OpenTrials
Completed

NCT Number: NCT02524041

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HR-pQCT

Device

The Xtrem CT scanco device is a HR-pQCT used for 3D bone measurements at the tibia and the radius levels in humans

Other names: Xtrem CT scanco

blood specimen

Other

blood specimen

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • University Hospital, Geneva

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 14, 2015
Registry last updated
May 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.