Volumetric Bone Mineral Density and it's Relationship Wit... | NCT03095690

Studies
Volumetric Bone Mineral Density and it's Relationship With Osteoporotic Fractures in Parkinson's Disease

NCT03095690

Sponsor

Centre Hospitalier Régional d'Orléans

Status

Completed

Last Update Posted

Mar 13, 2018Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Idiopathic Parkinson's Disease

Interventions

High resolution peripheral scanner (HRpQCT).

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2016Actual

Primary Completion Date

Jul 2016Actual

Completion Date

Jun 21, 2017Actual

First Submitted Date

Feb 8, 2017

First Submission Date that Met QC Criteria

Mar 24, 2017

First Posted Date

Mar 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2018

Last Update Posted Date

Mar 13, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Idiopathic Parkinson's Disease patients	Other	High resolution peripheral scanner (HRpQCT).	Other: High resolution peripheral scanner (HRpQCT).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High resolution peripheral scanner (HRpQCT).	Other	radius and tibia osteodensitometry measurement	Idiopathic Parkinson's Disease patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of volumetric bone mineral density at the tibia and radius	Measurement performed by High Resolution peripheral Quantitative Computed Tomography (HRpQCT)	0 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric LESPESSAILLES, Ph	CHR d'ORLEANS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHR d'ORLEANS		Orléans		45067	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D010024	Osteoporosis

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided