Bone Architectural Parameters in Postmenopausal Women Affected With Primary Hyperparathyroidism (MicrOs)

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.

Study Overview

• Status: Completed
• Conditions: Primary Hyperparathyroidism; Bone Disease
• Intervention / Treatment: Device: HR-pQCT

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hopital Europeen Georges Pompidou
  • Paris, France, 75010
    • Hopital Lariboisiere
  • Paris, France, 75014
    • Hopital Cochin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 81 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• diseases or medications interfering with bone and mineral metabolism

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Control post menopausal women without PHPT	Device: HR-pQCT; HR-pQCT to evaluate cortical and trabecular bone
Experimental: Experimental; Post menopausal women with PHPT followed for one year	Device: HR-pQCT; HR-pQCT to evaluate cortical and trabecular bone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cortical thickness measured by HR-pQCT	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
Three-dimensional evaluation of the cortical and trabecular bone by HR-pQCT	one year
Biological and quantitative parameters (assessed by HR-pQCT)	one year
Clinical, biological and bone densitometry parameters (assessed by DXA)	one year

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Gerard MARUANI, MD, Hôpital Européen Georges Pompidou (HEGP)

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 3, 2015

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Primary Hyperparathyroidism; Parathyroid Hormone; Bone microarchitecture; High-Resolution peripheral Quantitative Computed Tomography; Bone densitometry
• Additional Relevant MeSH Terms: Endocrine System Diseases; Musculoskeletal Diseases; Parathyroid Diseases; Hyperparathyroidism; Hyperparathyroidism, Primary; Bone Diseases
• Other Study ID Numbers: P091113