NCT02539498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

4.7 years

First QC Date

April 27, 2015

Last Update Submit

September 20, 2019

Conditions

Primary HyperparathyroidismBone Disease

Keywords

Primary HyperparathyroidismParathyroid HormoneHigh-Resolution peripheral Quantitative Computed TomographyBone densitometryBone microarchitecture

Outcome Measures

Primary Outcomes (1)

  • Cortical thickness measured by HR-pQCT

    one year

Secondary Outcomes (3)

  • 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

Study Arms (2)

Control

ACTIVE COMPARATOR

Control post menopausal women without PHPT

Device: HR-pQCT

Experimental

EXPERIMENTAL

Post menopausal women with PHPT followed for one year

Device: HR-pQCT

Interventions

HR-pQCTDEVICE

HR-pQCT to evaluate cortical and trabecular bone

ControlExperimental

Eligibility Criteria

AgeUp to 81 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • diseases or medications interfering with bone and mineral metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hopital Lariboisiere

Paris, 75010, France

Location

Hopital Cochin

Paris, 75014, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

MeSH Terms

Conditions

Hyperparathyroidism, PrimaryBone Diseases

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System DiseasesMusculoskeletal Diseases

Study Officials

  • Gerard MARUANI, MD

    Hopital Europeen Georges Pompidou (HEGP)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2015

First Posted

September 3, 2015

Study Start

April 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 23, 2019

Record last verified: 2019-09

Locations

FR(3)