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Volumetric Bone Mineral Density and it's Relationship With Osteoporotic Fractures in Parkinson's Disease (DOPPA)

Primary Purpose

Idiopathic Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High resolution peripheral scanner (HRpQCT).
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Idiopathic Parkinson's Disease focused on measuring Osteoporosis, Parkinson, HR-pQCT, bone microstructure, fracture risk

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHR d'ORLEANS

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Idiopathic Parkinson's Disease patients

Arm Description

High resolution peripheral scanner (HRpQCT).

Outcomes

Primary Outcome Measures

Measurement of volumetric bone mineral density at the tibia and radius
Measurement performed by High Resolution peripheral Quantitative Computed Tomography (HRpQCT)

Secondary Outcome Measures

Full Information

First Posted
February 8, 2017
Last Updated
March 12, 2018
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT03095690
Brief Title
Volumetric Bone Mineral Density and it's Relationship With Osteoporotic Fractures in Parkinson's Disease
Acronym
DOPPA
Official Title
Determinants of Volumetric Bone Mineral Density at the Tibia and Radius and it's Relationship With Osteoporotic Fractures in Idiopathic Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 7, 2016 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
June 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease
Keywords
Osteoporosis, Parkinson, HR-pQCT, bone microstructure, fracture risk

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Idiopathic Parkinson's Disease patients
Arm Type
Other
Arm Description
High resolution peripheral scanner (HRpQCT).
Intervention Type
Other
Intervention Name(s)
High resolution peripheral scanner (HRpQCT).
Intervention Description
radius and tibia osteodensitometry measurement
Primary Outcome Measure Information:
Title
Measurement of volumetric bone mineral density at the tibia and radius
Description
Measurement performed by High Resolution peripheral Quantitative Computed Tomography (HRpQCT)
Time Frame
0 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric LESPESSAILLES, Ph
Organizational Affiliation
CHR d'ORLEANS
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'ORLEANS
City
Orleans
ZIP/Postal Code
45067
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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