HyperparathyroidismNCT02524041
Association Between Serum Periostin Levels and Cortical Porosity in Patients With Secondary Hyperparathyroidism
A study testing HR-pQCT and blood specimen in people with Hyperparathyroidism, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperparathyroidism
- What is being tested?
- HR-pQCT and blood specimen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hyperparathyroidism defined by a parathyroid hormone serum level above 65 ng/ml, secondary to Chronic Kidney Disease (CKD) ou vitamin D deficiency
Who cannot join
- 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.
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- Lack of study understanding.
- Lack of agreement.
- Under legal control.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- HR-pQCT, blood specimen
- Keywords
- Hyperparathyroidism, microarchitecture, periostin
- Medical subject headings
- Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR-pQCTDevice
Also called Xtrem CT scanco
The Xtrem CT scanco device is a HR-pQCT used for 3D bone measurements at the tibia and the radius levels in humans
blood specimenOther
blood specimen
| Study group | Role | What they receive |
|---|---|---|
| secondary hyperparathyroidism | Experimental | Blood specimen and HR-pQCT for measure bone quality and quantity Receives: Device: HR-pQCT; Other: blood specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between periostin level and cortical porosity
Correlation between periostin serum level (ng/ml) and cortical porosity. Cortical porosity (%) is measured by HR-pQCT
Measured: day 1
Secondary outcomes (4)
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)
- Trabecular distribution (mm)
Measured: day 1
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)
- Trabecular distribution (mm)
Measured: day 1
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.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startMar 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor
- Investigators
- Thierry THOMAS, MD PhD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524041
- Sponsor's protocol ID
- 1308046
- Other IDs
- 130560B-22
- Status last verified
- May 2016
- First submitted
- 13 Aug 2015
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Serum Periostin Levels and Cortical Porosity in Patients With Secondary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT02524041
- Acronym / sponsor ID
- 1308046
- Conditions
- Hyperparathyroidism
- Keywords
- Hyperparathyroidism, microarchitecture, periostin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- Mar 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| secondary hyperparathyroidism | Experimental | Device: HR-pQCT, Other: blood specimenBlood specimen and HR-pQCT for measure bone quality and quantity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hyperparathyroidism defined by a parathyroid hormone serum level above 65 ng/ml, secondary to Chronic Kidney Disease (CKD) ou vitamin D deficiency
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR-pQCTAlso: Xtrem CT scancoThe Xtrem CT scanco device is a HR-pQCT used for 3D bone measurements at the tibia and the radius levels in humans | Device | secondary hyperparathyroidism |
| blood specimenblood specimen | Other | secondary hyperparathyroidism |
Primary outcome
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
4 secondary outcomes
Correlation between periostin level and other trabecular and cortical microarchitectural parameters (composite outcome)
Time frame: day 1
Correlation between parathyroid hormon level and other trabecular and cortical microarchitectural parameters (composite outcome)
Time frame: day 1
Correlation between Sclerostin serum level and cortical porosity
Time frame: Day 1
Correlation between parathyroid hormon level and cortical porosity
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry THOMAS, MD PhD principal investigator
CHU de SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HR-pQCT and blood specimen in people with Hyperparathyroidism, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between periostin level and cortical porosity (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2016.