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

NCT02524041 | Completed

• 2 other identifiers: 1308046130560B-22
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperparathyroidism

Keywords

Hyperparathyroidism; microarchitecture; periostin

Outcome Measures

Primary Outcomes (1)

• Correlation between periostin level and cortical porosity

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

  day 1

Secondary Outcomes (4)

• Correlation between periostin level and other trabecular and cortical microarchitectural parameters (composite outcome)

  day 1

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

  day 1

• Correlation between Sclerostin serum level and cortical porosity

  Day 1

• Correlation between parathyroid hormon level and cortical porosity

  Day 1

Study Arms (1)

secondary hyperparathyroidism

EXPERIMENTAL

Blood specimen and HR-pQCT for measure bone quality and quantity

Device: HR-pQCT; Other: blood specimen

Interventions

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

Also known as: Xtrem CT scanco

secondary hyperparathyroidism

blood specimen OTHER

blood specimen

secondary hyperparathyroidism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hyperparathyroidism defined by a parathyroid hormone serum level above 65 ng/ml, secondary to Chronic Kidney Disease (CKD) ou vitamin D deficiency

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• University Hospital, Geneva: collaborator

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Hyperparathyroidism

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Thierry THOMAS, MD PhD

  CHU de SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 14, 2015
• Study Start: March 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 25, 2016

Record last verified: 2016-05

Locations

FR (1)