Primary HyperparathyroidismMicrOsNCT02539498
Bone Architectural Parameters in Postmenopausal Women Affected With Primary Hyperparathyroidism
A study testing HR-pQCT in people with Primary Hyperparathyroidism and Bone Disease, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Bone lesions are frequent in primary hyperparathyroidism (PHPT). Conventional measurement by Dual-Energy X-ray Absorptiometry does not provide enough information about the bone impact of excessive parathyroid hormone (PTH) secretion. Read more about this study
- Who is it for?
- Ages Up to 81 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Hyperparathyroidism, Bone Disease
- What is being tested?
- HR-pQCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 3 sitesFrance
- Study dates
- Apr 2012to Dec 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 Up to 81 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients: caucasian women, menopaused for at least one year, aged less than 81 years, affected with symptomatic or asymptomatic PHPT
- Control population: caucasian women, menopaused for at least one year, aged less than 81 years, without PHPT
Who cannot join
- diseases or medications interfering with bone and mineral metabolism
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hopital Lariboisiere
Paris, 75010
Hopital Cochin
Paris, 75014
Hopital Europeen Georges Pompidou
Paris, 75015
About this study
Official title: Characterization of Bone Architectural Parameters Assessed by High-Resolution Peripheral Quantitative Computed Tomography in Post-menopausal Women Affected With Primary Hyperparathyroidism
Bone lesions are frequent in primary hyperparathyroidism (PHPT). Conventional measurement by Dual-Energy X-ray Absorptiometry does not provide enough information about the bone impact of excessive parathyroid hormone (PTH) secretion. High-Resolution peripheral Quantitative Computed Tomography (HR-pQCT) assesses separately cortical and trabecular bone sites as well as geometric characteristics of peripheral skeleton. In postmenopausal women, HR-pQCT has shown that decreased microarchitectural parameters are associated with reduced bone strength independently of BMD. The purpose of this study is to characterize the impact of PHPT in cortical and trabecular bone measured by HR-pQCT in postmenopausal women with PHPT followed for one year, in comparison with control postmenopausal women.
Read the detailed description
Principal objective : To characterize the impact of PHPT in cortical and trabecular bone measured by HR-pQCT in postmenopausal women with PHPT followed for one year, in comparison with control postmenopausal women.
Secondary Objectives : 1) To compare the changes of bone micro-architecture in PHPT women with and without surgery to those of controls 2) To determine if the changes of micro-architecture are related to the severity of PTH secretion and to their changes after surgery 3) to evaluate the association of clinical and biological factors with quantitative bone micro-architectural indices and their changes.
Principal evaluation criteria : Cortical thickness
Secondary evaluation criteria : Quantitative parameters measured with HR-pQCT: trabecular microarchitecture (trabecular bone volume, number, separation, thickness and heterogeneity of trabeculae), cortical microarchitecture (total surface, polar moment of inertia), volumetric density of total, cortical and trabecular bone. Biological parameters: PTH, serum calcium and phosphorus, 25(OH)D, 1,25(OH)2D, biomarkers of bone remodelling, and urinary calcium. BMD measured by DXA. Clinical factor risks of bone loss.
Type of study : Pathophysiological, multicentric, comparative study, with a prospective follow-up of one year in postmenopausal caucasian women affected with PHPT (cases) or non affected by PHPT (controls). Each control will be matched for age, date of menopause, height and weight, to PHPT women.
Study design: assessment of bone and mineral metabolism, DXA and measurement of indices by HR-pQCT at the inclusion. Those tests will be renewed one year after surgery for the PHPT patients and one year after baseline for those without surgery and the controls.
Number of patients needed: 120 postmenopausal women, 60 cases and 60 controls
Total duration of the study: 56 months. Inclusion period : 42 months
Inclusion criteria and principal non-inclusion criteria :
Patients: caucasian women, menopaused for at least one year, aged less than 81 years, affected with symptomatic or asymptomatic PHPT and without any other disease or medication interfering with bone and mineral metabolism. Control population: caucasian women, menopaused for at least one year, aged less than 81 years, without PHPT, diseases or medications interfering with bone and mineral metabolism.
- Conditions
- Primary Hyperparathyroidism, Bone Disease
- Being tested
- HR-pQCT
- Keywords
- Primary Hyperparathyroidism, Parathyroid Hormone, High-Resolution peripheral Quantitative Computed Tomography, Bone densitometry, Bone microarchitecture
- Medical subject headings
- Hyperparathyroidism, Primary, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR-pQCTDevice
HR-pQCT to evaluate cortical and trabecular bone
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Control post menopausal women without PHPT Receives: Device: HR-pQCT |
| Experimental | Experimental | Post menopausal women with PHPT followed for one year Receives: Device: HR-pQCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical thickness measured by HR-pQCT
Measured: one year
Secondary outcomes (3)
Three-dimensional evaluation of the cortical and trabecular bone by HR-pQCT
Measured: one year
Biological and quantitative parameters (assessed by HR-pQCT)
Measured: one year
Clinical, biological and bone densitometry parameters (assessed by DXA)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startApr 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerard MARUANI, MD, Principal investigator, Hopital Europeen Georges Pompidou (HEGP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539498
- Sponsor's protocol ID
- P091113
- Acronym
- MicrOs
- Status last verified
- Sep 2019
- First submitted
- 27 Apr 2015
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Bone Architectural Parameters Assessed by High-Resolution Peripheral Quantitative Computed Tomography in Post-menopausal Women Affected With Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT02539498
- Acronym / sponsor ID
- MicrOs / P091113
- Conditions
- Primary Hyperparathyroidism, Bone Disease
- Keywords
- Primary Hyperparathyroidism, Parathyroid Hormone, High-Resolution peripheral Quantitative Computed Tomography, Bone densitometry, Bone microarchitecture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Sep 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.
Bone lesions are frequent in primary hyperparathyroidism (PHPT). Conventional measurement by Dual-Energy X-ray Absorptiometry does not provide enough information about the bone impact of excessive parathyroid hormone (PTH) secretion. High-Resolution peripheral Quantitative Computed Tomography (HR-pQCT) assesses separately cortical and trabecular bone sites as well as geometric characteristics of peripheral skeleton. In postmenopausal women, HR-pQCT has shown that decreased microarchitectural parameters are associated with reduced bone strength independently of BMD. The purpose of this study is to characterize the impact of PHPT in cortical and trabecular bone measured by HR-pQCT in postmenopausal women with PHPT followed for one year, in comparison with control postmenopausal women.
Detailed description
Principal objective : To characterize the impact of PHPT in cortical and trabecular bone measured by HR-pQCT in postmenopausal women with PHPT followed for one year, in comparison with control postmenopausal women.
Secondary Objectives : 1) To compare the changes of bone micro-architecture in PHPT women with and without surgery to those of controls 2) To determine if the changes of micro-architecture are related to the severity of PTH secretion and to their changes after surgery 3) to evaluate the association of clinical and biological factors with quantitative bone micro-architectural indices and their changes.
Principal evaluation criteria : Cortical thickness
Secondary evaluation criteria : Quantitative parameters measured with HR-pQCT: trabecular microarchitecture (trabecular bone volume, number, separation, thickness and heterogeneity of trabeculae), cortical microarchitecture (total surface, polar moment of inertia), volumetric density of total, cortical and trabecular bone. Biological parameters: PTH, serum calcium and phosphorus, 25(OH)D, 1,25(OH)2D, biomarkers of bone remodelling, and urinary calcium. BMD measured by DXA. Clinical factor risks of bone loss.
Type of study : Pathophysiological, multicentric, comparative study, with a prospective follow-up of one year in postmenopausal caucasian women affected with PHPT (cases) or non affected by PHPT (controls). Each control will be matched for age, date of menopause, height and weight, to PHPT women.
Study design: assessment of bone and mineral metabolism, DXA and measurement of indices by HR-pQCT at the inclusion. Those tests will be renewed one year after surgery for the PHPT patients and one year after baseline for those without surgery and the controls.
Number of patients needed: 120 postmenopausal women, 60 cases and 60 controls
Total duration of the study: 56 months. Inclusion period : 42 months
Inclusion criteria and principal non-inclusion criteria :
Patients: caucasian women, menopaused for at least one year, aged less than 81 years, affected with symptomatic or asymptomatic PHPT and without any other disease or medication interfering with bone and mineral metabolism. Control population: caucasian women, menopaused for at least one year, aged less than 81 years, without PHPT, diseases or medications interfering with bone and mineral metabolism.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: HR-pQCTControl post menopausal women without PHPT |
| Experimental | Experimental | Device: HR-pQCTPost menopausal women with PHPT followed for one year |
Who may qualify
- Ages
- Up to 81 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients: caucasian women, menopaused for at least one year, aged less than 81 years, affected with symptomatic or asymptomatic PHPT
- Control population: caucasian women, menopaused for at least one year, aged less than 81 years, without PHPT
Key exclusion criteria (1 listed)
- diseases or medications interfering with bone and mineral metabolism
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-pQCTHR-pQCT to evaluate cortical and trabecular bone | Device | Control, Experimental |
Primary outcome
Cortical thickness measured by HR-pQCT
Time frame: one year
3 secondary outcomes
Three-dimensional evaluation of the cortical and trabecular bone by HR-pQCT
Time frame: one year
Biological and quantitative parameters (assessed by HR-pQCT)
Time frame: one year
Clinical, biological and bone densitometry parameters (assessed by DXA)
Time frame: one year
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 23 Sep 2019.
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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.
Gerard MARUANI, MD principal investigator
Hopital Europeen Georges Pompidou (HEGP)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HR-pQCT in people with Primary Hyperparathyroidism and Bone Disease, run by Assistance Publique - Hôpitaux de Paris at 3 sites 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 2 inclusion and 1 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 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Cortical thickness measured by HR-pQCT (time frame: one year). 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 23 Sep 2019.