Clinical Trials Directory

Trials / Completed

CompletedNCT02524041

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
22 (actual)
Sponsor
Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 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.

Conditions

Interventions

TypeNameDescription
DEVICEHR-pQCTThe Xtrem CT scanco device is a HR-pQCT used for 3D bone measurements at the tibia and the radius levels in humans
OTHERblood specimenblood specimen

Timeline

Start date
2014-03-01
Primary completion
2016-04-01
Completion
2016-04-01
First posted
2015-08-14
Last updated
2016-05-25

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02524041. Inclusion in this directory is not an endorsement.