Ignite Creation Date:
2024-05-06 @ 7:26 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02539498
Status:
COMPLETED
Last Update Posted:
2019-09-23
First Post:
2015-04-27
Brief Title:
Bone Architectural Parameters in Postmenopausal Women Affected With Primary Hyperparathyroidism
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Characterization of Bone Architectural Parameters Assessed by High-Resolution Peripheral Quantitative Computed Tomography in Post-menopausal Women Affected With Primary Hyperparathyroidism
Status:
COMPLETED
Status Verified Date:
2019-09
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:
MicrOs
Brief 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 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 25OHD 125OH2D 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
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 25OHD 125OH2D 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 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