Association Between Serum Periostin Levels and Cortical Porosity in Patients With Secondary Hyperparathyroidism
Primary Purpose
Hyperparathyroidism
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HR-pQCT
blood specimen
Sponsored by
About this trial
This is an interventional basic science trial for Hyperparathyroidism focused on measuring Hyperparathyroidism, microarchitecture, periostin
Eligibility Criteria
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.
Sites / Locations
- CHU de SAINT-ETIENNE
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
secondary hyperparathyroidism
Arm Description
Blood specimen and HR-pQCT for measure bone quality and quantity
Outcomes
Primary Outcome Measures
Correlation between periostin level and cortical porosity
Correlation between periostin serum level (ng/ml) and cortical porosity. Cortical porosity (%) is measured by HR-pQCT
Secondary Outcome Measures
Correlation between periostin level and other trabecular and cortical microarchitectural parameters (composite outcome)
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)
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
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
Correlation between parathyroid hormon serum level (pg/ml) and cortical porosity.Cortical porosity (%) is measured by HR-pQCT.
Full Information
NCT ID
NCT02524041
First Posted
August 13, 2015
Last Updated
May 24, 2016
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT02524041
Brief Title
Association Between Serum Periostin Levels and Cortical Porosity in Patients With Secondary Hyperparathyroidism
Official Title
Association Between Serum Periostin Levels and Cortical Porosity in Patients With Secondary Hyperparathyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
University Hospital, Geneva
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism
Keywords
Hyperparathyroidism, microarchitecture, periostin
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
secondary hyperparathyroidism
Arm Type
Experimental
Arm Description
Blood specimen and HR-pQCT for measure bone quality and quantity
Intervention Type
Device
Intervention Name(s)
HR-pQCT
Other Intervention Name(s)
Xtrem CT scanco
Intervention Description
The Xtrem CT scanco device is a HR-pQCT used for 3D bone measurements at the tibia and the radius levels in humans
Intervention Type
Other
Intervention Name(s)
blood specimen
Intervention Description
blood specimen
Primary Outcome Measure Information:
Title
Correlation between periostin level and cortical porosity
Description
Correlation between periostin serum level (ng/ml) and cortical porosity. Cortical porosity (%) is measured by HR-pQCT
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Correlation between periostin level and other trabecular and cortical microarchitectural parameters (composite outcome)
Description
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)
Time Frame
day 1
Title
Correlation between parathyroid hormon level and other trabecular and cortical microarchitectural parameters (composite outcome)
Description
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)
Time Frame
day 1
Title
Correlation between Sclerostin serum level and cortical porosity
Description
Correlation between Sclerostin serum level (ng/ml) and cortical porosity.Cortical porosity (%) is measured by HR-pQCT.
Time Frame
Day 1
Title
Correlation between parathyroid hormon level and cortical porosity
Description
Correlation between parathyroid hormon serum level (pg/ml) and cortical porosity.Cortical porosity (%) is measured by HR-pQCT.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry THOMAS, MD PhD
Organizational Affiliation
CHU de SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de SAINT-ETIENNE
City
Saint-etienne
ZIP/Postal Code
42000
Country
France
12. IPD Sharing Statement
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Association Between Serum Periostin Levels and Cortical Porosity in Patients With Secondary Hyperparathyroidism
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