NCT03095690

Brief Summary

Idiopathic Parkinson's disease (IPD) is the second most frequent neurodegenerative disease. Its association with osteroporosis and fragility fracture is now clearly demonstrated, but the determinants of this osteoporosis are yet to be explained. Our aim was to study factors associated with volumetric bone mineral density (vBMD) and bone microstructure at the tibia and radius in IPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2017

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

6 months

First QC Date

February 8, 2017

Last Update Submit

March 12, 2018

Conditions

Idiopathic Parkinson's Disease

Keywords

OsteoporosisParkinsonHR-pQCTbone microstructurefracture risk

Outcome Measures

Primary Outcomes (1)

  • Measurement of volumetric bone mineral density at the tibia and radius

    Measurement performed by High Resolution peripheral Quantitative Computed Tomography (HRpQCT)

    0 hour

Study Arms (1)

Idiopathic Parkinson's Disease patients

OTHER

High resolution peripheral scanner (HRpQCT).

Other: High resolution peripheral scanner (HRpQCT).

Interventions

High resolution peripheral scanner (HRpQCT).OTHER

radius and tibia osteodensitometry measurement

Idiopathic Parkinson's Disease patients

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with idiopathic Parkinson's disease according to the criteria of the UKPDBB.
  • Parkinson's disease of moderate severity (Index HOEHN and Yahr \<5)
  • Patient can respond to questionnaires, with or without help

You may not qualify if:

  • Patients with active psychiatric illness preventing the realization of examinations
  • Severe Parkinson's disease (Index HOEHN and Yahr ≥5 )
  • Heavy-morbidity including heart failure NYHA\> 3 or chronic respiratory failure, terminal or severe renal impairment known dialyzed
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR d'ORLEANS

Orléans, 45067, France

Location

MeSH Terms

Conditions

Parkinson DiseaseOsteoporosis

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Eric LESPESSAILLES, Ph

    CHR d'ORLEANS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2017

First Posted

March 30, 2017

Study Start

January 7, 2016

Primary Completion

July 1, 2016

Study Completion

June 21, 2017

Last Updated

March 13, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)