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

Idiopathic Parkinson's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03095690
• Other study ID #: CHRO-2015-05
• Status: Completed
• Phase: N/A
• First received: February 8, 2017
• Last updated: March 12, 2018
• Start date: January 7, 2016
• Est. completion date: June 21, 2017

Study information

• Verified date: March 2018
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 21, 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Osteoporotic Fractures
• Parkinson Disease

Intervention

Other:
• High resolution peripheral scanner (HRpQCT).
radius and tibia osteodensitometry measurement

Locations

Country	Name	City	State
France	CHR d'ORLEANS	Orleans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

Outcome

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