Ignite Creation Date:
2024-05-06 @ 7:25 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02524041
Status:
COMPLETED
Last Update Posted:
2016-05-25
First Post:
2015-08-13
Brief Title:
Association Between Serum Periostin Levels and Cortical Porosity in Patients With Secondary Hyperparathyroidism
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Association Between Serum Periostin Levels and Cortical Porosity in Patients With Secondary Hyperparathyroidism
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 130560B-22 | OTHER | ANSM | None |